This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
[Infographic] A One Page Guide to Global GDP GuidelinesPharma IQ
http://www.coldchainiq.com/regulatory-resources/white-papers/a-one-page-guide-to-global-gdp-guidelines/
All GDP guidelines in one single place!
Good Distribution Practice (GDP) is the part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation (MA) or product specification. There is no single global GDP standard. Cold Chain IQ has created this easy to-assimilate summary of GDP requirements around the world, enabling you to navigate the landscape. You can keep it as a handy reference, share it around your colleagues or even stick it on your wall!
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
[Infographic] A One Page Guide to Global GDP GuidelinesPharma IQ
http://www.coldchainiq.com/regulatory-resources/white-papers/a-one-page-guide-to-global-gdp-guidelines/
All GDP guidelines in one single place!
Good Distribution Practice (GDP) is the part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation (MA) or product specification. There is no single global GDP standard. Cold Chain IQ has created this easy to-assimilate summary of GDP requirements around the world, enabling you to navigate the landscape. You can keep it as a handy reference, share it around your colleagues or even stick it on your wall!
Leading Practices for Distribution SuccessNet at Work
As the pace of change in business accelerates—especially for those still relying on aged, on-premise ERP systems, wholesale distributors are struggling to keep up. Today’s leading distribution businesses need a proven solution that can be deployed quickly, predictably, and affordably, setting you up for growth and success.
Marv Shepherd, PSM president, Member USP Package Storage and Distribution Expert Committee, and Professor at the University of Texas at Austin speaks about updates to United States Pharmacopeia's good distribution practices.
The purpose of Gap Analysis is to assist pharmaceutical manufacturers, distributors or 3 PLs (3rd Party Logistics Providers) to help them identify gaps in their cold chain supply chain network or systems.
What you will learn:
* The regulatory aspects related to the cold chain
* Responsibilities in the supply chain
* Requirements for the storage and handling of drug products
* Packaging, transportation and distribution of drug products
* Performing a gap analysis to know what needs to be done in order to fully comply with regulations and optimize your processes
* Ways and means to develop an executable action plan
How you will benefit:
* Understand how to execute a cold chain regulatory gap analysis
* Discover what should be covered when looking at cold chain compliance
* Gap analysis: The first step to develop a cold chain compliance program
* Uncover the requirements for the storage and distribution of drug products
* Sharing the responsibilities for a good cold chain compliance
A Step-By-Step Guide To CDSCO _Medical Device Registration.pdfPranshuCorpseed
In the complex world of healthcare, where people's lives are on the line, maintaining the quality, safety, and efficacy of medical devices is a non-negotiable need. The Central Drugs Standard Control Organization (CDSCO) is a vigilant monitor in India's vibrant healthcare business. The crucial role of CDSCO is around the rigorous registration and regulation of medical devices, and its impact is felt throughout the entire healthcare ecosystem.
IMDRF’s New Regulatory Landscape for Personalized Medical DevicesEMMAIntl
The International Medical Device Regulators Forum (IMDRF) has recently issued a final guidance document to outline its expectations around the regulatory landscape for personalized medical devices. This recent guidance document builds on the previous IMDRF document, ‘Definitions for Personalized Medical Devices’...
Quality Function Deployment (QFD) for Design ControlsEMMAIntl
The Food and Drug Administration (FDA) has requirements for medical device manufacturers to establish and maintain a quality system for their medical device(s). The requirement for a quality system does not necessarily introduce new concepts, but applies existing quality concepts to design, development, manufacturing, distribution and use of medical devices. Within the larger quality system requirement, a methodology to control device design and development of medical devices is required. This set of sub requirements is known as Design Controls. In this paper, the history and evolution of quality systems and their application to medical devices will be covered. A Quality tool that could be well applied to the specific area of design controls, Quality Function Deployment (QFD), is a focus of this paper.
A Review on Approval Process and Regulation of Medical Devices as Per US FDA ...ijtsrd
The approval process and regulation of medical devices constitute a crucial aspect of ensuring patient safety, efficacy, and the availability of innovative healthcare solutions. This comprehensive review examines the approval procedures and regulatory frameworks for medical devices in two prominent regulatory agencies the US Food and Drug Administration FDA and the Central Drugs Standard Control Organization CDSCO in India. The article provides insights into the evolving landscape of medical device regulations, beginning with an overview of the key definitions and classifications employed by both agencies. A detailed exploration of the pre market approval pathways, including 510 k clearance and premarket approval PMA in the US, and the various classes and application types in India, sheds light on the rigorous evaluation processes medical devices undergo. The review also delves into the post market surveillance and vigilance mechanisms implemented by the FDA and CDSCO, emphasizing the importance of continuous monitoring to identify and mitigate potential risks associated with medical devices. Comparative analysis between the two regulatory bodies elucidates the nuances in terms of regulatory requirements, timelines, and pathways, reflecting the diverse healthcare landscapes they serve. The challenges and future directions in medical device regulation are also addressed, including the need for harmonization, rapid technological advancements, and the importance of global collaboration. Ultimately, this review underscores the significance of robust regulatory frameworks in fostering patient safety, fostering innovation, and ensuring the accessibility of safe and effective medical devices on a global scale. Navya G | Veeresh N | Sumita Debnath "A Review on Approval Process and Regulation of Medical Devices as Per US FDA and CDSCO" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-4, August 2023, URL: https://www.ijtsrd.com/papers/ijtsrd59800.pdf Paper Url:https://www.ijtsrd.com/other-scientific-research-area/other/59800/a-review-on-approval-process-and-regulation-of-medical-devices-as-per-us-fda-and-cdsco/navya-g
Medical Devices Regulations in Hong Kong for Registration of Devices of different class based on risk profile.
In Hong Kong, all medical devices intended for local sale, import, or use must be registered with the MDCO. The Medical devices registration process involves the following steps:
a. Submission of Application: Manufacturers or their authorized representatives must submit a registration application along with relevant supporting documents, including the device's technical specifications, labelling services, and evidence of compliance with relevant standards.
b. Review and Evaluation: The MDCO reviews the application to ensure compliance with safety, performance, and quality requirements. They may request additional information or clarification during the evaluation process.
c. Approval and Issuance of Certificate: Upon successful review, the MDCO grants a registration certificate, allowing the manufacturer to market the medical device in Hong Kong. The certificate is valid for a specified duration, typically five years.
Classification of Medical Devices in Hong Kong
Medical devices in Hong Kong are classified based on the potential risks associated with their use. The classification system helps determine the regulatory requirements and level of scrutiny imposed on each device class. The classification categories in Hong Kong are as follows:
a. Class I: Low-risk devices, such as bandages or tongue depressors, which do not require registration but must comply with relevant safety standards.
b. Class II: Medium-risk devices, including certain diagnostic equipment and non-invasive devices, which require registration and conformity assessment.
c. Class III: High-risk devices, such as implantable devices and life-supporting equipment, which require registration, conformity assessment, and additional scrutiny.
Post-Market Surveillance of Medical Devices in Hong Kong
To ensure the ongoing safety and quality of medical devices in Hong Kong, the Medical Device Control Office (MDCO) carries out comprehensive post-market surveillance activities. These activities encompass:
a. Adverse Event Reporting: All manufacturers, healthcare professionals, and users have a responsibility to promptly report any adverse events or incidents associated with medical devices to the MDCO. This reporting system plays a critical role in identifying potential risks and facilitating appropriate actions to mitigate them.
b. Market Sampling and Inspections: The MDCO conducts regular random sampling and inspections of registered medical devices to assess their adherence to regulatory requirements and quality standards. This proactive approach helps ensure that the devices available in the market meet the necessary safety and performance criteria.
c. Device Recalls & Safety Alerts:
https://www.artixio.com/post/medical-devices-regulations-in-hong-kong
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
Medical Device Registration in India_ A Comprehensive Guide.pdfPranshuCorpseed
The dynamic landscape of healthcare, the regulatory framework governing medical devices plays a pivotal role in ensuring the safety, efficacy, and quality of products in the market.
A crucial stage in clinical research is clinical data management CDM , which produces high quality, reliable, and statistically sound data from clinical trials. This results in a significantly shorter period of time between drug development and marketing. Team members of CDM are laboriously involved in all stages of clinical trials right from commencement to completion. They should be able to sustain the quality standards set by CDM processes by having sufficient process expertise. colorful procedures in CDM including Case Report Form CRF designing, CRF reflection, database designing, data entry, data confirmation, distinction operation, medical coding, data birth, and database locking are assessed for quality at regular intervals during a trial. In the present script, theres an increased demand to ameliorate the CDM norms to meet the nonsupervisory conditions and stay ahead of the competition by means of brisk commercialization of products. With the perpetration of nonsupervisory biddable data operation tools, the CDM platoon can meet these demands. also, its getting obligatory for companies to submit the data electronically. CDM professionals should meet applicable prospects and set norms for data quality and also have the drive to acclimatize to the fleetly changing technology. This composition highlights the processes involved and provides the anthology an overview of the tools and norms espoused as well as the places and liabilities in CDM. Syed Shahnawaz Quadri | Syeda Saniya Ifteqar | Syed Shafa Raoof "Data Management in Clinical Research" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd55050.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/other/55050/data-management-in-clinical-research/syed-shahnawaz-quadri
“Current Approach of Quality by Design” An Overviewijtsrd
In this Analysis, well look at how QbD is being practised right now. QbD represents a cutting edge methodology for enhancing the safety and efficacy of pharmaceuticals. Quality by Design QbD is a relatively new idea in the pharmaceutical industry, but it has quickly become an integral aspect of the current approach to quality. Quality by Design relies on the ICH Guidelines as its basis. Guidelines Q8 for Pharmaceutical Development, Q9 for Quality Risk Management, and Q10 for Pharmaceutical Quality Systems from the International Council for Harmonization ICH served as inspiration for this document. QbD is the most effective method now available for improving the quality of all pharmaceutical goods, but it poses a significant problem for the pharmaceutical business, whose procedures are traditionally static. Eventually, despite inevitable process and material variation, It is crucial to establish the desired product performance profile Target product Profile TPP , Target Product Quality Profile TPQP and to pinpoint the attributes of quality that are most important to the products success throughout the QbD process CQA . We may then use this information to tailor the products composition and production method to those characteristics. This results in the identification and management of sources of variability and an understanding of the effect of raw materials critical material attributes CMA and critical process parameters CPP on critical quality attributes CQAs . To which the process and technique of development must have access. Quality by Design QbD encompasses the processes of drug development and manufacturing. that guarantees the product meets the standards set out in advance. R. Kavi Bharathi | R. Sanil Kumar | Shantaram Nangude "“Current Approach of Quality by Design” An Overview" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-1 , February 2023, URL: https://www.ijtsrd.com/papers/ijtsrd53873.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/53873/“current-approach-of-quality-by-design”-an-overview/r-kavi-bharathi
Similar to Good Distribution Practices For Medical Devices (20)
As per S.R.O. 526 (I)/2021 an extension in exemption period for registration of medical device has been announced and a new Schedule E has been introduced.
Medical device Regulations (Pakistan) flow timeMUHAMMAD SOHAIL
It indicates the flow time for Pakistan medical device rules.It begins from declaring some items as drug and making their registration compulsory afther that Medical Device term was introduced and in 2015 Medical Device Rules were notified.
Guidance document on GDPMD and Site Master File from DRAPMUHAMMAD SOHAIL
Guidance documents on Good Distribution Practices for Medical Devices and Site Master File as per Medical Devices Rule 2015 issued by Drug Regulatory Authority of PAKISTAN
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Navigating the Health Insurance Market_ Understanding Trends and Options.pdfEnterprise Wired
From navigating policy options to staying informed about industry trends, this comprehensive guide explores everything you need to know about the health insurance market.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
Welcome to Secret Tantric, London’s finest VIP Massage agency. Since we first opened our doors, we have provided the ultimate erotic massage experience to innumerable clients, each one searching for the very best sensual massage in London. We come by this reputation honestly with a dynamic team of the city’s most beautiful masseuses.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
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2. GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)
1
Introduction
Distribution is an important activity in the integrated supply-chain of medical
device. Various people and entities are generally responsible for the product
sourcing, procurement, transportation, delivery, storage, device tracking,
installation, commissioning, service and maintenance, calibration, need to be
appropriately managed and controlled to ensure the safety and performance of medical
devices at the point of use. In some cases, however, a person or entity is only
involved in and responsible for certain elements of the distribution process. The level
of risks associated with these activities may be of similar degree as those in the
manufacturing environment and the lack of control over these activities may affect
safety and performance of the devices. The Good Distribution Practice for Medical
Devices (GDPMD) is developed to elucidate the requirements for an appropriate
management and control of these activities.
GDPMD specifies the requirements for a quality management system to be established,
implemented and maintained by an establishment in carrying out activities in medical
device supply-chain to comply with Pakistan medical device regulatory requirements as
stipulated in Medical Devices Rules 2015. GDPMD requires an establishment to
demonstrate its ability to maintain quality, safety and performance of medical devices in
compliance with the Pakistan medical device regulatory requirement throughout the
supply-chain. It shall be used by both the internal and external parties to determine
the ability of an establishment to meet the requirements specified within.
The certification to GDPMD is to be conducted by the registered conformity assessment
body. The design and implementation of GDPMD by an establishment is dependent on
the types and categories and classification of medical device, size and structure of the
establishment, the processes employed it deals with. It is not the intent of the GDPMD to
imply uniformity in the structure of the quality management systems or uniformity
of documentation.
Certification to GDPMD does not imply compliance to any written laws. It is
the responsibility of the establishment to ensure that they are in compliance with
all applicable laws in Pakistan. In the event of any contradiction between the
requirements of GDPMD and any written law, the latter shall take precedence.
3. GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)
2
Contents
PART 1: PRELIMINARY............................................................................................................................. 4
Objective............................................................................................................................................. 4
Scope and application......................................................................................................................... 4
Definitions........................................................................................................................................... 4
PART 2: ORGANIZATION AND GDPMD REGULATORY COMPLIANCE SYSTEM ........................................ 6
Organization........................................................................................................................................ 6
GDPMD regulatory compliance system .............................................................................................. 7
General ........................................................................................................................................... 7
Documentation ............................................................................................................................... 7
Document control........................................................................................................................... 8
PART 3: ESTABLISHMENT RESPONSIBILITIES .......................................................................................... 8
Responsibilities and authorities.......................................................................................................... 8
Designated person .............................................................................................................................. 9
Management review........................................................................................................................... 9
Review input ....................................................................................................................................... 9
Review output...................................................................................................................................10
PART 4: RESOURCE MANAGEMENT......................................................................................................10
Personnel ..........................................................................................................................................10
Training, competency and awareness .............................................................................................. 10
Infrastructure....................................................................................................................................10
Work environment............................................................................................................................11
Cleanliness and pest control.............................................................................................................11
PART 5: SUPPLY CHAIN AND DEVICE SPECIFIC...................................................................................... 12
Authorization ....................................................................................................................................12
Communication channels .................................................................................................................12
Receipt of stock ................................................................................................................................12
Storage and stock handling...............................................................................................................12
Stock rotation ...................................................................................................................................13
Delivery to customers .......................................................................................................................13
Control of nonconforming medical devices including returned medical devices ............................ 14
Disposal of medical devices ..............................................................................................................14
Traceability .......................................................................................................................................15
Specific traceability requirements for implantable medical devices............................................ 15
Specific requirements for active medical devices ............................................................................ 16
Outsourced activities ........................................................................................................................17
Counterfeit adulterate, unwholesome and tampered medical services.......................................... 17
Secondary assembly including repackaging ..................................................................................... 17
General requirements...................................................................................................................17
Assembly documents....................................................................................................................18
Materials control ..........................................................................................................................18
Labeling.........................................................................................................................................19
Good assembly practices ..............................................................................................................19
Quality control ..............................................................................................................................19
PART 6: SURVEILLANCE AND VIGILANCE .............................................................................................. 20
General .............................................................................................................................................20
Medical device complaints ...............................................................................................................20
Distribution records ..........................................................................................................................20
Field corrective action (FCA) and field safety notice (FSN)............................................................... 21
Recall.................................................................................................................................................21
4. GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)
3
Mandatory problem reporting .........................................................................................................21
Internal audits...................................................................................................................................22
Corrective action...............................................................................................................................22
Preventive action ..............................................................................................................................22
5. GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)
4
PART 1: PRELIMINARY
Objective
1. The objective of this document is to ensure the quality, safety and performance of
medical device during all aspects of medical device supply-chain, which include, but not
limited to, product sourcing and procurement; transportation and delivery;
storage; installation, commissioning, service and maintenance, calibration and after sales
service; tracking, documentation and record-keeping practices.
Scope and application
2. (1) This document, “Good Distribution Practice for Medical Devices (GDPMD)”, is
made pursuant to Appendix 4 of Schedule 3 of the Medical Device Regulation 2012 and
is applicable to all parties involved in the supply-chain of medical device covering
authorized representatives of foreign manufacturers, importers or distributors of medical
devices in Pakistan. The scope of this document does not cover manufacturers and
retailers of medical devices.
(2) The design and implementation of GDPMD by an establishment is dependent
on the types and categories and classification of medical device, size and structure of
the establishment, the processes employed it deals with. If any requirement in GDPMD is
not applicable due to the type, category and classification of the medical device and
supply chain activities, a justification has to be provided for exclusion from fulfillment of
that particular requirement. If any requirement in GDPMD is not applicable due to the
nature and the range of the medical device and supply chain activities, a justification has
to be provided for exclusion from fulfillment of that particular requirement.
(3) When the terms “as appropriate” or “as applicable” are used to qualify a
requirement in the GDPMD, it is deemed to be “appropriate” or “applicable” unless the
establishment can document a justification otherwise.
(4) The certification to GDPMD is to be conducted by the registered conformity
assessment body and the scope of GDPMD certification is defined in Annex 1.
Definitions
3. In this document, unless the context otherwise requires—
“active medical device” means any medical device as defined in Medical Device
Rules 2015;
“adverse effect” means any debilitating, harmful or detrimental effect that
the medical device has been found to have or to be likely to have on the
body or health of humans when such a medical device is used by or
administered to humans;
“adverse event” means any event or other occurrence, that reveals any defect in
any medical device or that concerns any adverse effect arising from the
use thereof;
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“Authority” means the Medical Device Authority established under Medical Device
Rules 2015;
“customer complaint” means any written, electronic or oral communication that
alleges deficiencies related to the identity, quality, durability, reliability, safety
or performance of a medical device that has been placed on the market;
“distribution” means the activities of pre (release), placement (delivery) and
post-delivery of medical devices conducted by the establishment;
“distributor” means any natural or legal person in the supply chain who, on
his own behalf, places a medical device on the market and further the
availability of the medical device to the end user including persons in the supply
chain involved in activities such as storage and transport on behalf of
the authorized representative, importer or distributor;
“field corrective action (FCA)” is an action taken by a manufacturer to reduce
a risk of death or serious deterioration in the state of health associated with the
use of a medical device, which may include—
(i) return of a medical device to the manufacturer or its representative;
(ii) medical device modification, which may include—
- retrofit in accordance with the manufacturer's modification or design
change;
- permanent or temporary changes to the labeling or instructions for use;
- software upgrades including those carried out by remote access;
- modification to the clinical management of patients to address a risk of
serious injury; or
- death related specifically to the characteristics of the device.
(iii) medical device exchange;
(iv) medical device destruction;
(v) medical advice given by manufacturer regarding the use of the device. Note:
In assessing the need of the FCA the establishment is advised to use the
methodology described in the ISO 14971:2007 Medical devices –
Application of risk management to medical devices;
“field safety notice (FSN)” means a communication sent out by a manufacturer or
its representative to the device users in relation to a FCA;
“import” means to bring or cause to be brought a medical device manufactured in
another country or jurisdiction, into Pakistan by land, sea or air;
“importer” means any natural or legal person in the supply chain who imports
a medical device into Pakistan;
“installation qualification (IQ)” means a documented demonstration that facilities
and operations are installed as designed and specified and are correctly
interfaced with systems, with protocols that should include—
(i) engineering drawings and documents;
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(ii) building finishes;
(iii) process and utilities flow diagrams;
(iv) piping and instrumentation diagrams;
(v) equipment and instrument specifications;
(vi) manufacturers’ drawings, equipment maintenance and operating manuals;
(vii) spare lists; and
(viii)maintenance and calibration schedules;
“place in the market” means an activity as defined in Medical Devices Rules
2015;
“premises” for the purpose of this document, means any location that is used for
activities dealing with medical devices, including storage, manufacture, etc.
“packaging” for the purposes of this document, means the container and other
packaging material in which the medical device is supplied;
“primary package” means element of packaging system that maintains the
sterility and/or integrity of a medical device;
“regulatory requirement” means the requirement stipulated under Medical
Devices Rules 2015;
“secondary assembly” means the process of repackaging of a medical device
from its original packaging into another packaging, without breach of the primary
package, before the medical device is supplied.
PART 2: ORGANIZATION AND GDPMD REGULATORY COMPLIANCE
SYSTEM
Organization
4. The establishment shall—
(i) define the organization structure with the aid of an organizational chart and
indicate the responsibility, authority and interrelationship of all key personnel;
(ii) define the duties and responsibilities with written job descriptions for every
level of the organization;
(iii) ensure managerial and technical personnel have the authority and resources
needed to carry out their duties; and
(iv) set up and maintain a GDPMD regulatory compliance system and identify and
correct deviations from the established system.
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GDPMD regulatory compliance system
General
5. The establishment shall—
(i) establish, document and implement a GDPMD regulatory compliance system
and maintain its compliance with the regulatory requirements;
(ii) identify the processes needed for the GDPMD regulatory compliance system
and their application for all categories of medical devices, regardless of the
type or size of the organization;
(iii) determine the sequence and interaction of these processes;
(iv) determine criteria and methods needed to ensure that both the operation and
control of these processes are effective in ensuring compliance;
(v) ensure the availability of resources and information necessary to support the
operation and monitoring of these processes;
(vi) monitor, measure and analyze these processes;
(vii) implement actions necessary to achieve planned results and maintain the
effectiveness of these processes to ensure compliance;
(viii)manage the processes in accordance with the regulatory requirements; and
(ix) identify and control outsourced processes in accordance with the regulatory
requirements.
Documentation
6. (1) The establishment shall establish and maintain a Regulatory Compliance
Manual which shall include the following information—
(i) establishment’s profile, activities/operations, compliance to medical
device regulatory requirements and obligations of the establishment,
including those outsourced processes or activities/operations;
(ii) the scope of the GDPMD regulatory compliance system, including details
of, and justification for any exclusion and/or non-application;
(iii) the medical devices it deals with and their status of compliance;
(iv) procedures required by GDPMD regulatory compliance system and
reference to them;
(v) documents needed by the establishment to ensure the effective planning,
operation and control of processes for compliance; and
(vi) records required by the GDPMD regulatory compliance system;
(vii) information regarding—
- the premises where activities are conducted;
- personnel conducting the activities; and
- the medical device conformity assessment and the registration
holder;
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(viii) detailed description on how the relevant and applicable regulatory
requirements are addressed for each medical device specified in the scope
of the GDPMD regulatory compliance system;
(2) For each type of medical device it deals with, the establishment shall establish
and maintain a file containing documents that define—
(i) product specifications and installation qualifications (if applicable);
(ii) complete distribution process and, if applicable, installation and
servicing.
Document control
7. (1) The establishment shall—
(i) control the documents required by GDPMD regulatory compliance system;
and
(ii) establish a documented procedure for the control of documents.
(2) All documents shall be prepared, approved, signed and dated by an authorized
person.
(3) The establishment shall give appropriate authorization on any change on
authorized person permitted to carry out the task in sub-clause (2).
(4) When a document has been revised, the control system shall prevent
unintended use of the superseded version.
(5) The establishment shall—
(i) establish and maintain records of GDPMD regulatory compliance system
that are legible, readily identifiable and retrievable;
(ii) establish a documented procedure to define the controls for the
identification, storage, protection, retrieval, retention time and disposition
of records; and
(iii) retain the records for a period of time—
- specified by relevant regulatory requirements; or
- at least equivalent to the lifetime of the medical device product as
defined by the product owner of the medical devices; or
- no less than two years from the date that the medical device is
shipped from the establishment, whichever is the longest.
PART 3: ESTABLISHMENT RESPONSIBILITIES
Responsibilities and authorities
8. The establishment shall—
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(i) ensure that responsibilities and authorities are defined, documented and
communicated within the establishment; and
(ii) establish the interrelation between all personnel who manage, perform and
verify works that affect quality, safety and performance of medical device and
shall ensure the independence and authority to perform these tasks.
Designated person
9. The establishment shall appoint a designated person who shall have the defined
responsibility and authority that includes—
(i) ensuring the GDPMD regulatory compliance system is established,
implemented and maintained;
(ii) reporting to top management on the performance of the GDPMD regulatory
compliance system, as well as to identify and correct deviations from the
established GDPMD regulatory compliance system;
(iii) ensuring the awareness on obligations to comply with regulatory requirements
and any other applicable statutory requirements and any decision thereof
made by top management throughout the establishment and supply chain; and
(iv) liaising with external parties on matters relating to the Pakistan medical
device regulatory requirements.
Management review
10. The management shall—
(i) review its GDPMD regulatory compliance system at planned intervals, to ensure
its compliance to Pakistan medical device regulatory requirements;
(ii) ensure the review includes assessment of the status of compliance and the
need for changes; and
(iii) maintain records of management reviews.
Review input
11. The input for management review shall include—
(i) results of internal and external audits;
(ii) customer complaints/feedback;
(iii) GDPMD regulatory compliance system and medical device compliance;
(iv) surveillance and vigilance activities including field safety corrective actions,
advisory notes, recalls and adverse event /incident reporting;
(v) feedback from manufacturer;
(vi) feedback and directives from the Authority;
(vii) status of preventive and corrective actions;
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(viii)follow-up actions from previous management reviews;
(ix) changes that could affect the GDPMD regulatory compliance system; and
(x) recommendations for compliance.
Review output
12. The output from the management review shall include any decisions and actions
related to—
(i) the corrective and preventive actions required;
(ii) the effectiveness of the GDPMD regulatory compliance system and its
compliance with the Pakistan medical device regulatory requirements; and
(iii) resource needs.
PART 4: RESOURCE MANAGEMENT
Personnel
13. (1) Key personnel in charge of managing activities/operations within the scope of
the establishment including technical support shall be competent and possesses
appropriate professional knowledge, education, training, skills and experience.
(2) Skills of personnel providing post market technical support for active medical
devices shall conform to the requirements and/or standards recognized by the Authority.
(3) The establishment shall possess an adequate number of competent personnel
involved in all activities/operations in the supply chain of the medical devices in order to
ensure the quality, safety and performance of the medical device are maintained.
Training, competency and awareness
14. The establishment shall—
(i) determine the necessary competence for the key personnel;
(ii) provide training to satisfy these needs;
(iii) evaluate the effectiveness of the training; and
(iv) maintain records of education, training, skills and experience.
Infrastructure
15. (1) The establishment shall determine, provide and maintain the infrastructure
needed to achieve conformity to specified requirements which includes, as applicable—
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(i) buildings, workspace, workshop and associated utilities;
(ii) tools, measuring and test equipment; and
(iii) supporting services (such as transport or communication).
(2) The establishment shall, as applicable—
(i) ensure that the premises and equipment used are suitable , secure, safe
and adequate in accordance with the manufacturer and regulatory
requirements to ensure proper conservation and distribution of medical
devices;
(ii) establish documented requirements for maintaining the premises and
equipment, including their frequencies; and
(iii) maintain records of such maintenance activities.
Work environment
16. The establishment shall, as applicable—
(i) determine and manage the work environment needed to achieve conformity to
regulatory requirements;
(ii) establish documented requirements for health, cleanliness and clothing of
personnel if contact between such personnel and the medical devices or work
environment could adversely affect quality of the medical devices;
(iii) establish documented procedures or work instructions to monitor and control
the conditions for work environment that could adversely affect quality of the
medical devices;
(iv) ensure that all personnel who are required to work temporarily under special
environmental conditions within the work environment are appropriately
trained or supervised by a trained person; and
(v) establish special arrangements and document the control of contaminated or
potentially contaminated medical devices, work environment or personnel.
Cleanliness and pest control
17. (1) The establishment shall, as applicable—
(i) establish documented requirements for the cleaning of premises,
including frequency and methods; and
(ii) maintain records of cleaning.
(2) The establishment shall—
(i) establish a pest control program to identify and prevent pest infestation;
and
(ii) maintain records of pest control program.
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MDA/RR No 1: July 2013 12
PART 5: SUPPLY CHAIN AND DEVICE SPECIFIC
Authorization
18. The establishment shall—
(i) obtain appropriate authorization from the relevant party to become authorized
representative, importer or distributor of medical devices; and
(ii) establish and maintain written agreement with the relevant party pertaining to
supply of information required for regulatory matters relating to medical
devices it deals with.
Communication channels
19. The establishment shall—
(i) establish and maintain communication channels and feedback mechanisms
with the relevant party such that all relevant and updated medical device
information can be disseminated to the related parties effectively;
(ii) be responsible to manage and to communicate with users, public and Authority
on matters pertaining to medical devices it deals with;
(iii) establish and maintain efficient communication channels with the
manufacturers, such that all relevant medical device information and updated
device information can be disseminated to the related parties effectively;
(iv) establish feedback mechanism for collecting comments and complaints from
users and public, to be forwarded to the relevant party as applicable;
(v) as applicable, establish mechanism to provide information on maintenance
services, including calibration, provision of spare parts and other services, to
the users.
Receipt of stock
20. The establishment shall—
(i) establish and implement inspection or other activities necessary to ensure that medical devices
received meets the specified requirements; and
(ii) maintain records of verification.
Storage and stock handling
21. (1) The establishment shall—
(i) identify storage measures for specific medical devices and stored in
accordance with the manufacturer’s instructions;
(ii) provide suitable and adequate storage to ensure proper conservation of
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the medical devices; and
(iii) maintain an updated distribution records of medical devices it deals with,
including the make, model, batch number, serial number, and quantity of
the devices, as appropriate.
(iv) establish adequate precautions and control to prevent deterioration or
damage of the medical devices;
(2) Where quarantine status is ensured by storage in separate areas, these areas
must be clearly marked and access restricted to authorized personnel.
(3) Any system replacing physical quarantine should provide equivalent security.
(4) Medical device presenting special risks of abuse, fire or explosion (such as
combustible/flammable liquids and solids and pressurized gases) should be stored in a
dedicated area(s) that is subject to appropriate additional safety and security measures.
(5) Broken or damaged medical device should be identified and withdrawn from
usable stock and stored separately.
Stock rotation
22. The establishment shall—
(i) establish a system to ensure stock rotation;
(ii) separate medical devices beyond their expiry date or shelf life from usable
stock and clearly labeled ; and
(iii) dispose the expired medical devices in accordance with clause 25.
Delivery to customers
23. The establishment shall—
(i) verify that the registered medical device is accompanied by certificate of
registration and license and other applicable documents and instructions for
use;
(ii) ensure that the medical device bears a type, batch or lot number, model and
serial number or other elements of identification as well as name, trade name
and address of the manufacturer and/or distributor organization;
(iii) ensure the designated medical devices should only be sold and/or distributed
to persons or entities that are entitled to acquire such medical devices as
specified by the regulatory requirements by obtaining the proof of such
authority prior to the distribution of medical devices to such person;
(iv) provide documentation of all medical devices supplied to customers to
ascertain the date, the name of the medical device, the quantity supplied, the
batch or lot number and/or model and serial number and the name and
address of the distributor and addressee;
(v) keep the record of delivery transactions as the proof of medical devices
supplied to customers;
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(vi) obtain all relevant conditions for storage and transportation, installation,
testing and commissioning requirements, user and service manuals, spare
parts list and relevant certificates from the manufacturer and provide to the
customer ;
(vii) ensure the delivery of medical devices adhere to the conditions specified by
the manufacturer;
(viii)establish adequate and specialized methods of delivery to achieve safe and
secure delivery of medical device from the point of collection to the point of
delivery; and
(ix) ensure the delivery of medical devices which present special risks of abuse,
fire or explosion are stored in safe, dedicated and secure areas, and
transported in safe, dedicated and secure containers and vehicles, and shall
comply with the applicable regulatory and/or statutory requirements.
Control of nonconforming medical devices including returned medical devices
24. The establishment shall—
(i) establish documented procedures for handling of returned medical device and
shall be treated as a non-conforming medical device;
(ii) ensure that medical device which does not conform to essential principles of
safety and performance as stipulated in Rules, is identified and controlled to
prevent its unintended delivery and use;
(iii) define the controls and related responsibilities and authorities for dealing with
nonconforming medical device in a documented procedure;
(iv) deal with nonconforming product by one or more of the following ways—
- by taking action to eliminate the detected nonconformity; and
- by authorizing its delivery and use under concession;
(v) ensure that nonconforming medical device is delivered and used by concession
only if the regulatory requirements are met;
(vi) maintain records of the justification and identity of the person(s) authorizing
the concession;
(vii) maintain records of the nature of nonconformities and any subsequent actions
taken, including concessions obtained from the manufacturer and the
Authority; and
(viii)take action appropriate to the effects, or potential effects, of the
nonconformity, when nonconforming product is detected after delivery.
Disposal of medical devices
25. The establishment shall—
(i) establish a documented procedure for the disposal of medical devices in
accordance with regulatory requirements and any other applicable statutory
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requirements;
(ii) ensure, if the medical device have not been immediately sent for disposal, they
shall be kept in a clearly segregated, safe and secured area and identified in
accordance with regulatory requirements and any other applicable statutory
requirement; and
(iii) maintain records of the disposal.
Traceability
26. (1) The establishment shall—
(i) maintain an updated records providing traceability of medical devices
throughout the supply chain being dealt with, which include the make,
model, batch number, serial number, and quantity of devices, as
appropriate;
(ii) retain the records for a period of time—
- specified by relevant regulatory requirements; or
- at least equivalent to the lifetime of the medical device as defined by
the manufacturer of the medical devices; or
- no less than two years from the date that the medical device is
shipped from the establishment, whichever is the longest;
(iii) ensure all parties involved in the supply chain shall be identifiable; and
(iv) establish measures to ensure traceability of the medical device
throughout distribution channels from the manufacturer/importer to the
customer and to the patient.
(2) Records including expiry dates and batch records shall be part of a secure
distribution documentation enabling traceability.
Specific traceability requirements for implantable medical devices
27. (1) The establishment shall establish a tracking record for all implants especially
the following high-risk medical devices down to patient level—
(i) mechanical heart valves;
(ii) implantable pacemakers, their electrodes and leads;
(iii) implantable defibrillators, their electrodes and leads;
(iv) implantable ventricular support systems; and
(v) implantable drug infusion systems.
(2) If tracking is not possible for any individual medical devices (e.g. the tracking
does not have the patient’s consent), the tracking system is still required as follows—
(i) to track the medical devices down to the healthcare facility level; or
(ii) to keep track of the following—
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- the date of the medical device was put into service or implanted into
a patient, and
- the date the device permanently retired from use or for an implanted
medical device, the date it was explanted.
(3) The establishment shall submit surveillance reports to the Authority at least
once a year for all the above stated medical devices.
Specific requirements for active medical devices
28. (1) The establishment shall establish and maintain documented procedures and
work instructions for performing installation, testing and commissioning and
maintenance activities.
(2) The establishment shall—
(i) establish and maintain documented procedures, work instructions and
reference materials, tools and test equipment and reference
measurement procedures, for performing servicing activities including
calibration, repair, maintenance and verifying that they meet the
regulatory requirements and applicable standards;
(ii) establish documented requirements which contain acceptance criteria for
installation, testing and commissioning of the medical device;
(iii) establish installation qualification and maintain adequate installation and
inspection instructions for medical devices requiring specified installation
requirements, and where appropriate, test procedures;
(iv) ensure proper installation, testing and commissioning;
(v) ensure equipment used for testing, maintenance and conservation of
medical devices are calibrated or verified at specific intervals;
(vi) ensure the calibration and maintenance of test equipment conforms to
the applicable standards; and
(vii) maintain testing and commissioning, installation, calibration and
maintenance service records.
(3) The establishment shall, as appropriate—
(i) establish an appropriate technical support which include maintenance
service, training, calibration, management of spare parts, workshop setup
and management;
(ii) establish maintenance management mechanism to support the
customers;
(iii) ensure the technical and maintenance support services for active
medical devices conform to the applicable regulatory requirements.
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Outsourced activities
29. The establishment shall—
(i) ensure control over outsourced process within the scope of the GDPMD;
(ii) establish requirements to ensure that the outsourced activities conform to
specified requirements;
(iii) ensure the type and extent of control applied to the supplier are dependent on
the impact on meeting the requirements of GDPMD;
(iv) ensure, for outsourced activities, the supplier of outsourced activities is
audited as part of the establishment’s system unless the supplier is already
certified to GDPMD covering the scope of the outsourced activities; and
(v) develop written agreements with outsourced party to ensure that appropriate
measures are taken to safeguard the safety and performance of the medical
devices, including maintaining appropriate documentation and records, and
such agreements should be in accordance with regulatory requirements and
any relevant statutory requirements.
Note: Establishment shall ensure control over outsourced processes does not
absolve the establishment of the responsibility of conformity to GDPMD,
statutory and regulatory requirements.
Counterfeit adulterate, unwholesome and tampered medical services
30. The establishment shall, upon finding in this distribution network any counterfeit,
adulterate, and tampered medical devices—
(i) physically segregated from other medical devices to avoid any confusion;
(ii) clearly label any counterfeit, adulterate, and tampered medical devices found
in the distribution network as “Not for Sale” or other similar phrases/words;
and
(iii) inform the Authority and manufacturer immediately.
Secondary assembly including repackaging
General requirements
31. (1) The establishment shall plan and carry out secondary assembly of medical
devices under controlled conditions and shall include, as applicable—
(i) the availability of information that describes the characteristics of the
medical devices;
(ii) the availability of documented procedures, documented requirements,
work instructions, and reference materials and reference measurement
procedures as necessary;
(iii) the use of suitable equipment;
(iv) the availability and use of monitoring and measuring devices;
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(v) the implementation of monitoring and measurement activities;
(vi) the implementation of release of medical devices, their delivery and post-
delivery activities; and
(vii) the implementation of defined operations and packaging of medical
devices.
(2) The establishment shall—
(i) establish and maintain a record for each batch of medical devices that
provides traceability and identifies the amount assembled and the
amount approved for distribution; and
(ii) ensure the batch record shall be verified and approved by qualified
personnel.
Assembly documents
32. The establishment shall ensure—
(i) batch assembly record is kept for each batch or part batch assembled which
carries the batch number and the quantity of bulk medical devices to be
packed;
(ii) the assembly shall be made or completed at time each action is taken to trace
all significant activities concerning the assembly of medical device; and
(iii) the records are retained for a period of time—
- as specified in the regulatory requirements; or
- at least equivalent to the lifetime of the medical device as defined by the
product owner of the medical device; or
- no less than two years from the date that the medical device is shipped
from the establishment, whichever is longest.
Materials control
33. The establishment shall ensure—
(i) for each delivery, the incoming medical devices are checked for integrity of
package and seal, for correspondence between delivery note and the supplier’s
labels, and for compliance with quality specification;
(ii) medical devices with breached primary package are not used for secondary
assembly;
(iii) medical devices in the storage area are appropriately labeled;
(iv) appropriate procedures or measures are taken to assure the identity of the
contents of each packing of the medical devices;
(v) bulk containers from which quantities of the medical devices have been drawn
are clearly identified;
(vi) medical devices requiring special storage conditions are placed in areas which
are designed and equipped to provide the desired conditions;
(vii) the storage and conditions are continuously monitored and recorded;
(viii)the actual storage temperature are expressed quantitatively;
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(ix) the purchase, handling and control of all packaging materials are accorded
attention similar to that given to starting materials;
(x) packaging materials are issued for use only by authorized personnel in
accordance with the documented procedure;
(xi) when setting up a program for the packaging operations, particular attention is
given to minimize the risk of cross-contamination, mix-ups or substitutions; and
(xii) different medical devices shall not be packaged in close proximity unless there
is physical segregation.
Labeling
34. The establishment shall ensure the repackaged medical devices bear all original
labeling (including instruction for use, label and any other information sheet or leaflet,
etc) and all labeling information, except for quantity and the distributor identity.
Good assembly practices
35. The establishment shall ensure—
(i) all medical devices and materials used for assembly are checked before use by a
designated person for quantity, identity and conformity with the packaging
instructions;
(ii) line clearance are performed prior to commencement of the assembly
operation;
(iii) the correct performance of any printing operation which is carried out
separately or in the course of packaging are checked and recorded.
(iv) printing by hand is re-checked at regular intervals;
(v) assembly equipment/apparatus are cleaned according to detailed and written
procedures and stored only in a clean and dry condition;
(vi) assembly equipment/apparatus do not present any hazard to the medical
devices;
(vii) the parts of assembly equipment/apparatus that come into contact with the
medical devices do not affect the quality of the medical devices and present
any hazard; and
(viii)control equipment shall be calibrated and checked at defined intervals and
adequate records of the calibration shall be maintained.
Quality control
36. The establishment shall ensure—
(i) finished medical device assessment shall embrace all relevant factors,
including assembly conditions, a review of packaging documentation,
compliance with finished medical device specification and visual examination
of the final finished pack; and
(ii) the process of secondary assembly shall not compromise the conformity of the
medical device to essential principles of safety and performance.
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PART 6: SURVEILLANCE AND VIGILANCE
General
37. The establishment shall establish and implement a documented procedure for
monitoring safety and performance of medical devices imported, exported and placed in
the market.
Medical device complaints
38. (1) The establishment shall—
(i) establish and implement a documented procedure for handling
complaints regarding medical devices;
(ii) all complaints and other information concerning potentially defective and
counterfeit medical devices shall be reviewed including the description of
the action to be taken and reporting to all relevant parties, where
appropriate;
(iii) any complaint concerning a defective medical device shall be recorded
and thoroughly investigated to identify the origin or the reason for the
complaint;
(iv) maintain records of the complaint, investigation and any subsequent
actions taken; and
(v) where necessary, appropriate follow-up action should be taken after
investigation and evaluation of the complaint.
(2) The establishment should put in place a system by which the complaints, the
response received from the medical device manufacturer, or the results of the
investigation of the complaint, are shared with all the relevant parties.
Distribution records
39. The establishment shall—
(i) document all activities relating to the distribution of medical devices including
all applicable receipts, storage, delivery and disposal; and
(ii) the records shall contain at least the following—
- the name, address, e-mail and telephone number of the manufacturer,
authorized representative, importer, exporter, distributor and customer of
the device where appropriate; and
- the name of the device, its class and its identifier, including the identifier of
any medical device that is part of a system, test kit, medical device group,
medical device family or medical device group family.
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Field corrective action (FCA) and field safety notice (FSN)
40. The establishment shall—
(i) establish documented procedures for handling of FCA and field safety notice
(FSN);
(ii) define the responsibilities for planning, conducting and reporting of corrective
actions in the documented procedure;
(iii) establish in writing a recall or withdrawal procedure in consultation with
manufacturer;
(iv) inform the Authority prior to execution of FCA and FSN;
(v) inform all customers to whom the medical device was distributed with the
appropriate degree of urgency;
(vi) inform overseas counterparts on the FCA and FSN if the medical devices are
exported;
(vii) request that the affected medical devices be removed immediately from usable
stock and stored separately in a secure area until they are disposed of in
accordance with manufacturers’ instructions; and
(viii)maintain records of all actions taken in connection with the FCA and FSN and
their approval by the manufacturer and the Authority.
Recall
41. The establishment shall—
(i) establish a documented procedure to effectively and promptly recall medical
device known or suspected to be defective or counterfeit;
(ii) ensure that the system comply with the regulatory requirements;
(iii) the manufacturer and/or authorized representative shall be informed in the
event of a recall;
(iv) where a recall is instituted by an entity other than the manufacturer and/or
authorized representative, consultation with the manufacturer and/or
authorized representative should, where possible, take place before the recall
is instituted;
(v) recall information shall be reported to the Authority; and
(vi) the progress of a recall process should be recorded and a final report issued,
which includes a reconciliation between delivered and recovered quantities of
products.
Mandatory problem reporting
42. (1) The establishment shall establish documented procedure for incident/
problem reporting to comply with the regulatory requirements, which include—
(i) the identification of the nature of the incident/problem;
23. GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)
22
(ii) the investigation;
(iii) the evaluation and analysis; and
(iv) the action to be taken.
(2) Each incident report shall lead to a final report where corrective actions are
applicable.
Internal audits
43. The establishment shall—
(i) establish a documented procedure, defining the responsibilities and
requirements for planning and conducting audits and reporting of the results
and maintenance of the audit records;
(ii) plan an audit program, taking into consideration the status and importance of
the processes and areas to be audited, as well as the results of previous
audits;
(iii) define the audit criteria, scope, frequency and methods;
(iv) conduct internal audits at planned intervals to monitor the implementation of
and compliance with the requirements of GDPMD;
(v) records of the audits and their results shall be maintained; and
(vi) take actions to eliminate detected nonconformities and their causes without
undue delay.
Corrective action
44. The establishment shall—
(i) take action to eliminate the cause of nonconformities in order to comply with
GDPMD and regulatory requirements under ; and
(ii) a documented procedure shall be established to define requirements for:
- reviewing nonconformities (including customer complaints);
- determining the causes of nonconformities;
- evaluating the need for action to ensure that nonconformities do not recur;
- determining and implementing action needed, including, if appropriate,
updating documentation,
- recording of the results of any investigation and of action taken; and
- reviewing the corrective action taken and its compliance with GDPMD and
regulatory requirements.
Preventive action
45. The establishment shall—
24. GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)
23
(iii) determine proactive action to eliminate the causes of potential
nonconformities in order to comply with GDPMD and regulatory requirements
and preventive actions shall be appropriate to the effects of the potential
problems; and
(iv) establish a documented procedure to define requirements for—
- determining potential nonconformities and their causes;
- evaluating the need for action to prevent occurrence of nonconformities;
- determining and implementing action needed;
- recording of the results of any investigations and of action taken; and
- reviewing preventive action taken and its effectiveness.
25. GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)
24
ANNEX 1
Scope of GDPMD Certification
(1) The GDPMD certification shall specify the following—
(i) scope of activities performed by the establishment and medical devices
dealt with by the establishment;
(ii) outsourced activities, if applicable;
(iii) any special storage and handling conditions, such as chill room or cold
room for cold chain management; and
(iv) applicable sections of the Medical Device Rules.
(2) The following information shall be indicated in the certification of GDPMD—
(i) information on establishment seeking certification (which include name,
address and contact information);
(ii) information on other premises of the establishment (which include name,
address and contact information), if applicable, which are involved in
performing any activities within the scope of GDPMD certification and the
activities they perform; and
(iii) information on all premises (which include name, address and contact
information of all the premises), if applicable, which are involved in
performing any outsourced activities within the scope of GDPMD
certification of the establishment and the activities they perform.
(3) The certificate issued by the conformity assessment body (CAB) shall bear the
following information—
(i) particulars of CAB issuing the certificate which include the name and
address, company logo, registration number and the name and signature of
the certification manager of the CAB; and
(ii) particulars of the certificate issued to the establishment which include the
number, validity and expiry date of the certificate.
(4) Scope of activities for establishment (including those activities that are
outsourced) to be certified include anyone or combination of the following
activities—
(i) import;
(ii) storage and handling;
(iii) warehousing;
(iv) secondary assembly;
(v) distribution (including transportation);
(vi) installation, testing & commissioning (including the required facilities);
(vii) maintenance and calibration (including the required facilities); and
(viii) documentation (including traceability of medical devices).
26. GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)
25
(5) List of devices dealt with by the establishment—
No Name of
medical device
Manufacturer Brand/
model
Manufacturer
product
number/code
Grouping
(single/ family/
system/ test
kit/cluster
Class GMDN
code
Medical device
registration
number*
1
2
3
*If the medical device is pending registration, the GDPMD certification is provisional subject to the condition
that the medical device is registered. The provisional GDPMD certification is only valid during the transition
period for the medical device already in the market. The status of the GDPMD Certificate shall be stated
(provisional or valid).