S.R.O.32(I)/2018.— In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with the approval of the Federal Government, is pleased to make the following rules, namely
The document outlines the Pakistan Medical Devices Rules of 2017. It includes 15 chapters that cover topics such as establishing licenses for medical device manufacturers and importers, classifying and registering medical devices, importing and exporting, labeling, responsibilities of parties, exemptions, usage and maintenance, the Medical Device Board for appeals, the medical device register, fees, and advertising. It also lists the forms associated with the rules.
This document outlines the rules and regulations for medical devices in Pakistan, including classification, licensing, registration, labeling, and other requirements. Key points include:
- The Medical Device Board is responsible for regulating medical devices and conformity assessment bodies.
- Medical devices must be classified based on risk and undergo conformity assessment prior to registration and import/sale.
- Manufacturers and importers must obtain establishment licenses, which require meeting quality and premises standards and are valid for 5 years.
- Detailed procedures are defined for licensing, registration, labeling, post-market surveillance, exemptions, and other aspects of the medical device approval process.
Community Pharmacy: Defined as a place where the medicines are stocked and dispensed to the patients or patient care givers under the supervision of a qualified and registered pharmacist upon the production of a prescription or when legally permitted without the prescription
Good regulatory practice are internationally recognized process, system, tools and method for improving the quality of regulation.
It includes
1)COMMUNITY PHARMACY RETAIL AND WHOLESALE PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
2) HOSPITAL PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
3) PHARMA MANIFACTURING
-Dacumentation
-Licenses
-Renewal
-E-governance
4) IMPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
5) EXPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Rea...Greenlight Guru
While the enforcement of EU MDR might have been delayed another year, your preparations addressing requirements for post-market surveillance (PMS) should not be! These new PMS requirements push manufacturers to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current. Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered. In this session, learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
Talk takeaways:
• Understanding the new requirements of PMS under MDR
• What is the impact to the business?
• How do the requirements affect your current product lifecycle approach/QMS?
• Relationship between PMCF and PMS
• What to include in your plans and reports?
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
A combination product is defined as a product composed of two or more regulated components (drug, device, biologic) that are combined and produced as a single entity. Combination products may be classified as drugs or devices depending on their principal mechanism of action. Health Canada and the US FDA have policies for classifying combination products and determining which agency regulations apply. The sponsor can request a classification from the agencies, which will consider the product's components and principal mechanism of action.
This document discusses the WHO Prequalification of Medicines Programme and its requirements for active pharmaceutical ingredients (APIs). The programme facilitates access to priority medicines for diseases like HIV/AIDS, malaria, and tuberculosis. Manufacturers can submit dossier information on APIs using a Certificate of Suitability, an Active Pharmaceutical Ingredient Master File, or by providing all requested API data directly. The document outlines the guidelines and standards used to assess API quality in applications for prequalification.
The document discusses India's Drugs and Magic Remedies (Objectionable Advertisements) Act and provides several examples of misleading drug advertisements that have been prohibited under the Act. It outlines the objectives of the Act to control drug advertising and prohibit remedies alleged to possess magic qualities. It also defines key terms like advertisement, magic remedy, and drug. The document examines classes of prohibited advertisements, exempted advertisements, and penalties for violations of the Act. Overall, it analyzes India's laws around misleading and unsubstantiated claims in drug advertising.
The document outlines the Pakistan Medical Devices Rules of 2017. It includes 15 chapters that cover topics such as establishing licenses for medical device manufacturers and importers, classifying and registering medical devices, importing and exporting, labeling, responsibilities of parties, exemptions, usage and maintenance, the Medical Device Board for appeals, the medical device register, fees, and advertising. It also lists the forms associated with the rules.
This document outlines the rules and regulations for medical devices in Pakistan, including classification, licensing, registration, labeling, and other requirements. Key points include:
- The Medical Device Board is responsible for regulating medical devices and conformity assessment bodies.
- Medical devices must be classified based on risk and undergo conformity assessment prior to registration and import/sale.
- Manufacturers and importers must obtain establishment licenses, which require meeting quality and premises standards and are valid for 5 years.
- Detailed procedures are defined for licensing, registration, labeling, post-market surveillance, exemptions, and other aspects of the medical device approval process.
Community Pharmacy: Defined as a place where the medicines are stocked and dispensed to the patients or patient care givers under the supervision of a qualified and registered pharmacist upon the production of a prescription or when legally permitted without the prescription
Good regulatory practice are internationally recognized process, system, tools and method for improving the quality of regulation.
It includes
1)COMMUNITY PHARMACY RETAIL AND WHOLESALE PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
2) HOSPITAL PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
3) PHARMA MANIFACTURING
-Dacumentation
-Licenses
-Renewal
-E-governance
4) IMPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
5) EXPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Rea...Greenlight Guru
While the enforcement of EU MDR might have been delayed another year, your preparations addressing requirements for post-market surveillance (PMS) should not be! These new PMS requirements push manufacturers to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current. Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered. In this session, learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
Talk takeaways:
• Understanding the new requirements of PMS under MDR
• What is the impact to the business?
• How do the requirements affect your current product lifecycle approach/QMS?
• Relationship between PMCF and PMS
• What to include in your plans and reports?
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
A combination product is defined as a product composed of two or more regulated components (drug, device, biologic) that are combined and produced as a single entity. Combination products may be classified as drugs or devices depending on their principal mechanism of action. Health Canada and the US FDA have policies for classifying combination products and determining which agency regulations apply. The sponsor can request a classification from the agencies, which will consider the product's components and principal mechanism of action.
This document discusses the WHO Prequalification of Medicines Programme and its requirements for active pharmaceutical ingredients (APIs). The programme facilitates access to priority medicines for diseases like HIV/AIDS, malaria, and tuberculosis. Manufacturers can submit dossier information on APIs using a Certificate of Suitability, an Active Pharmaceutical Ingredient Master File, or by providing all requested API data directly. The document outlines the guidelines and standards used to assess API quality in applications for prequalification.
The document discusses India's Drugs and Magic Remedies (Objectionable Advertisements) Act and provides several examples of misleading drug advertisements that have been prohibited under the Act. It outlines the objectives of the Act to control drug advertising and prohibit remedies alleged to possess magic qualities. It also defines key terms like advertisement, magic remedy, and drug. The document examines classes of prohibited advertisements, exempted advertisements, and penalties for violations of the Act. Overall, it analyzes India's laws around misleading and unsubstantiated claims in drug advertising.
“The regulatory landscape for biotech products in Ukraine”
Illustrates the current norms in place in Ukraine for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars
The pharmaceutical value chain involves three main components: manufacturing the drug, distributing it, and dispensing it to patients. Manufacturing includes research and development, clinical trials, regulatory approval, and commercial production. It represents a significant cost, especially for innovative drugs that can take over a decade to develop. Generic manufacturers have lower costs. The value provided includes new medical treatments and wider health and economic benefits. Manufacturers' net prices are often lower than list prices due to discounts negotiated with buyers. The level of discount varies between generic and branded drugs and countries.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
WHO-ART and MedDRA are medical terminologies used for adverse event reporting. WHO-ART has a 4-level hierarchical structure with over 6,000 terms, while MedDRA is more extensive with over 72,000 terms organized into system organ classes. Both terminologies aim to standardize terminology for use by drug regulators and manufacturers, though MedDRA was developed further through international collaboration and is now the predominant global standard.
The regulatory guidelines of Australia provide a comprehensive framework for regulating therapeutic goods including medicines. Key aspects of the framework include:
1. Therapeutic goods are classified as either registered or listed medicines depending on their risk level. Registered medicines undergo more rigorous assessment of safety, quality and efficacy.
2. The main legislation is the Therapeutic Goods Act of 1989, which establishes national controls for medicines. Other regulations and committees provide supportive governance.
3. For approval, medicines must be listed or registered on the Australian Register of Therapeutic Goods through a pre-market assessment of safety, quality and sometimes efficacy. Extensive evaluation and oversight is provided by the Therapeutic Goods Administration and its committees.
The document outlines the procedures for registering medical devices in Pakistan according to the Medical Devices Rules of 2015. It discusses what constitutes a medical device and the application process for initial registration and renewal of registration. It lists the conditions of registration including maintaining records of clinical investigations and reporting adverse events. It also describes the procedures for cancelling or suspending a registration if the conditions are not met.
Schedule Y is the law in India that regulates clinical trials. It was established in 1988 under the Drugs and Cosmetics Act and amended in 2005 to better protect citizens and ensure data is acceptable internationally. Schedule Y outlines requirements for permission to import or manufacture new drugs and conduct clinical trials. It describes the responsibilities of sponsors, investigators, and ethics committees. It provides guidelines for informed consent, different trial phases, and special populations. Overall, Schedule Y aims to enable stringent yet favorable regulations for clinical trials in India.
This document discusses pharmacovigilance and adverse drug reaction reporting. It defines types of adverse drug reactions and the role of pharmacovigilance in monitoring drug safety. It describes the Yellow Card Scheme used in the UK to collect reports of suspected adverse reactions which are then analyzed by the MHRA to ensure drug safety. New drugs are placed under additional monitoring through the Black Triangle Scheme to closely track any adverse effects.
The document provides an overview of the history and development of pharmacy as a profession in India. It discusses the ancient, pre-independence, and post-independence periods. It also covers the historical background of pharmacy education and the pharmaceutical industry in India. Additionally, it introduces key pharmacopoeias including the Indian Pharmacopoeia, and summarizes the editions published to date.
This document discusses pharmacovigilance and the need for monitoring drug safety post approval. It describes how historical drug safety issues like the Elixir Sulfanilamide and Thalidomide tragedies revealed limitations in pre-approval testing and established the need for ongoing pharmacovigilance. The aims, application and reporting processes of pharmacovigilance are outlined along with terminology and examples of regulatory actions taken based on adverse event reporting.
The document compares the drug approval processes in the US and India. In the US, the process involves an Investigational New Drug (IND) application to begin clinical trials, followed by a New Drug Application (NDA) if clinical studies show the drug is safe and effective. In India, companies must apply for permission by submitting data to the Drugs Controller General of India and conduct clinical trials according to guidelines. Both countries have stringent approval standards aimed at safeguarding public health by ensuring drugs are properly tested and manufactured.
Medicines registration & licensing of pharmaceutical establishments of NepalSR drug laboratories
This document discusses medicines registration and licensing of pharmaceutical establishments according to Nepal's Drugs Registration Rules, 2038. It outlines the legal framework and institutional setup, including requirements to obtain recommendation letters from the Drug Development Agency to establish a drug industry or for export/import, as well as licenses needed for manufacturing and marketing drugs. It notes some areas for improvement, such as clarifying procedures, setting time limits, separating registration by drug type, reducing duplicate registration efforts, and simplifying the registration process through online facilities.
The document discusses the evolving role of pharmacists from a focus on dispensing medications to a greater focus on patient care and disease management. It outlines how pharmacists can work with patients and healthcare providers to optimize drug therapy, educate patients, manage chronic conditions like asthma and diabetes, and reduce healthcare costs through interventions and prevention of drug-related problems. Pharmacist involvement in disease management has demonstrated improvements in patient outcomes.
This document discusses good regulatory practices across different pharmacy settings. It defines good regulatory practices as internationally recognized processes, systems, tools and methods for improving the quality of regulation. It then discusses good regulatory practices for community pharmacies, wholesale pharmacies, hospital pharmacies, and manufacturing and import/export of drugs and medical devices. Key aspects of good regulatory practices include online licensing and renewal systems, electronic record-keeping for traceability, documentation standards, and the use of electronic medical record systems.
1) Poison information centres provide information to identify and treat poisonings from any compound. They aim to reduce accidental poisoning deaths, provide rapid access to treatment information, and assist with poison prevention.
2) Poison information centres operate 24/7 to provide immediate assistance, handle a high call volume, and respond to more complex cases compared to drug information centres. They are also better staffed and funded.
3) Organizing an effective poison information centre requires qualified personnel like medical directors, managers, information specialists, and educators. It also requires appropriate facilities, equipment, resources, policies, training, and quality improvement programs.
The document provides information on India's drug regulatory system. It states that the Drug Controller General of India heads the Central Drug Standard Control Organisation, which regulates drugs in India. The objectives of the drug regulatory authority are to ensure medicinal products are of acceptable quality, safe, and effective. It also discusses new drug approval processes, definitions of new drugs, application forms and fees for various regulatory processes like clinical trials, manufacturing, and import of drugs.
The Mansoura CPD-DIC is an academic drug information center operated under the faculty of medicine at Mansura University. It aims to increase community knowledge about drugs and proper drug use. The DIC provides drug information to healthcare professionals by answering questions about drug availability, identification, therapy, side effects, dosage, interactions and more. It offers information services, consultations, and participates in pharmacology research. The DIC team consists of a chief, director, and vice director. It is equipped with sources like primary literature, secondary publications, formularies and internet resources to thoroughly research and respond to drug information requests.
summary of indian medical device rule 2017Arshadib
This document outlines the key points of the Indian Medical Device Rules of 2017. It defines medical devices and explains why regulation is necessary. It describes the various authorities and bodies involved in enforcement and oversight. The rules cover the classification, manufacturing, import, labeling, clinical investigation, and sale of medical devices in India. Manufacturers must comply with quality management standards and obtain the necessary licenses from the Central or State Licensing Authorities depending on the class of device. Clinical investigations require approval and oversight from ethics committees. The rules aim to improve safety, quality and ensure medical devices meet appropriate standards.
Guidelines for import and manufacture of medical devicesluojn126
This document outlines guidelines for importing and manufacturing medical devices in India. It declares certain sterile devices like stents and implants to be considered drugs and regulated accordingly. It provides procedures for registering and obtaining import licenses for these medical devices. Manufacturers must apply to state licensing authorities and provide details about manufacturing facilities, processes, and product standards to be allowed to locally produce these devices. The guidelines aim to regulate and monitor the quality of imported and locally-made medical devices.
“The regulatory landscape for biotech products in Ukraine”
Illustrates the current norms in place in Ukraine for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars
The pharmaceutical value chain involves three main components: manufacturing the drug, distributing it, and dispensing it to patients. Manufacturing includes research and development, clinical trials, regulatory approval, and commercial production. It represents a significant cost, especially for innovative drugs that can take over a decade to develop. Generic manufacturers have lower costs. The value provided includes new medical treatments and wider health and economic benefits. Manufacturers' net prices are often lower than list prices due to discounts negotiated with buyers. The level of discount varies between generic and branded drugs and countries.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
WHO-ART and MedDRA are medical terminologies used for adverse event reporting. WHO-ART has a 4-level hierarchical structure with over 6,000 terms, while MedDRA is more extensive with over 72,000 terms organized into system organ classes. Both terminologies aim to standardize terminology for use by drug regulators and manufacturers, though MedDRA was developed further through international collaboration and is now the predominant global standard.
The regulatory guidelines of Australia provide a comprehensive framework for regulating therapeutic goods including medicines. Key aspects of the framework include:
1. Therapeutic goods are classified as either registered or listed medicines depending on their risk level. Registered medicines undergo more rigorous assessment of safety, quality and efficacy.
2. The main legislation is the Therapeutic Goods Act of 1989, which establishes national controls for medicines. Other regulations and committees provide supportive governance.
3. For approval, medicines must be listed or registered on the Australian Register of Therapeutic Goods through a pre-market assessment of safety, quality and sometimes efficacy. Extensive evaluation and oversight is provided by the Therapeutic Goods Administration and its committees.
The document outlines the procedures for registering medical devices in Pakistan according to the Medical Devices Rules of 2015. It discusses what constitutes a medical device and the application process for initial registration and renewal of registration. It lists the conditions of registration including maintaining records of clinical investigations and reporting adverse events. It also describes the procedures for cancelling or suspending a registration if the conditions are not met.
Schedule Y is the law in India that regulates clinical trials. It was established in 1988 under the Drugs and Cosmetics Act and amended in 2005 to better protect citizens and ensure data is acceptable internationally. Schedule Y outlines requirements for permission to import or manufacture new drugs and conduct clinical trials. It describes the responsibilities of sponsors, investigators, and ethics committees. It provides guidelines for informed consent, different trial phases, and special populations. Overall, Schedule Y aims to enable stringent yet favorable regulations for clinical trials in India.
This document discusses pharmacovigilance and adverse drug reaction reporting. It defines types of adverse drug reactions and the role of pharmacovigilance in monitoring drug safety. It describes the Yellow Card Scheme used in the UK to collect reports of suspected adverse reactions which are then analyzed by the MHRA to ensure drug safety. New drugs are placed under additional monitoring through the Black Triangle Scheme to closely track any adverse effects.
The document provides an overview of the history and development of pharmacy as a profession in India. It discusses the ancient, pre-independence, and post-independence periods. It also covers the historical background of pharmacy education and the pharmaceutical industry in India. Additionally, it introduces key pharmacopoeias including the Indian Pharmacopoeia, and summarizes the editions published to date.
This document discusses pharmacovigilance and the need for monitoring drug safety post approval. It describes how historical drug safety issues like the Elixir Sulfanilamide and Thalidomide tragedies revealed limitations in pre-approval testing and established the need for ongoing pharmacovigilance. The aims, application and reporting processes of pharmacovigilance are outlined along with terminology and examples of regulatory actions taken based on adverse event reporting.
The document compares the drug approval processes in the US and India. In the US, the process involves an Investigational New Drug (IND) application to begin clinical trials, followed by a New Drug Application (NDA) if clinical studies show the drug is safe and effective. In India, companies must apply for permission by submitting data to the Drugs Controller General of India and conduct clinical trials according to guidelines. Both countries have stringent approval standards aimed at safeguarding public health by ensuring drugs are properly tested and manufactured.
Medicines registration & licensing of pharmaceutical establishments of NepalSR drug laboratories
This document discusses medicines registration and licensing of pharmaceutical establishments according to Nepal's Drugs Registration Rules, 2038. It outlines the legal framework and institutional setup, including requirements to obtain recommendation letters from the Drug Development Agency to establish a drug industry or for export/import, as well as licenses needed for manufacturing and marketing drugs. It notes some areas for improvement, such as clarifying procedures, setting time limits, separating registration by drug type, reducing duplicate registration efforts, and simplifying the registration process through online facilities.
The document discusses the evolving role of pharmacists from a focus on dispensing medications to a greater focus on patient care and disease management. It outlines how pharmacists can work with patients and healthcare providers to optimize drug therapy, educate patients, manage chronic conditions like asthma and diabetes, and reduce healthcare costs through interventions and prevention of drug-related problems. Pharmacist involvement in disease management has demonstrated improvements in patient outcomes.
This document discusses good regulatory practices across different pharmacy settings. It defines good regulatory practices as internationally recognized processes, systems, tools and methods for improving the quality of regulation. It then discusses good regulatory practices for community pharmacies, wholesale pharmacies, hospital pharmacies, and manufacturing and import/export of drugs and medical devices. Key aspects of good regulatory practices include online licensing and renewal systems, electronic record-keeping for traceability, documentation standards, and the use of electronic medical record systems.
1) Poison information centres provide information to identify and treat poisonings from any compound. They aim to reduce accidental poisoning deaths, provide rapid access to treatment information, and assist with poison prevention.
2) Poison information centres operate 24/7 to provide immediate assistance, handle a high call volume, and respond to more complex cases compared to drug information centres. They are also better staffed and funded.
3) Organizing an effective poison information centre requires qualified personnel like medical directors, managers, information specialists, and educators. It also requires appropriate facilities, equipment, resources, policies, training, and quality improvement programs.
The document provides information on India's drug regulatory system. It states that the Drug Controller General of India heads the Central Drug Standard Control Organisation, which regulates drugs in India. The objectives of the drug regulatory authority are to ensure medicinal products are of acceptable quality, safe, and effective. It also discusses new drug approval processes, definitions of new drugs, application forms and fees for various regulatory processes like clinical trials, manufacturing, and import of drugs.
The Mansoura CPD-DIC is an academic drug information center operated under the faculty of medicine at Mansura University. It aims to increase community knowledge about drugs and proper drug use. The DIC provides drug information to healthcare professionals by answering questions about drug availability, identification, therapy, side effects, dosage, interactions and more. It offers information services, consultations, and participates in pharmacology research. The DIC team consists of a chief, director, and vice director. It is equipped with sources like primary literature, secondary publications, formularies and internet resources to thoroughly research and respond to drug information requests.
summary of indian medical device rule 2017Arshadib
This document outlines the key points of the Indian Medical Device Rules of 2017. It defines medical devices and explains why regulation is necessary. It describes the various authorities and bodies involved in enforcement and oversight. The rules cover the classification, manufacturing, import, labeling, clinical investigation, and sale of medical devices in India. Manufacturers must comply with quality management standards and obtain the necessary licenses from the Central or State Licensing Authorities depending on the class of device. Clinical investigations require approval and oversight from ethics committees. The rules aim to improve safety, quality and ensure medical devices meet appropriate standards.
Guidelines for import and manufacture of medical devicesluojn126
This document outlines guidelines for importing and manufacturing medical devices in India. It declares certain sterile devices like stents and implants to be considered drugs and regulated accordingly. It provides procedures for registering and obtaining import licenses for these medical devices. Manufacturers must apply to state licensing authorities and provide details about manufacturing facilities, processes, and product standards to be allowed to locally produce these devices. The guidelines aim to regulate and monitor the quality of imported and locally-made medical devices.
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
The healthcare industry in the UAE is growing rapidly as the government aims to improve healthcare standards and establish Dubai as a regional medical tourism hub. All medical devices sold in the UAE must be registered with the Ministry of Health. The registration guidelines were developed to prevent unsafe devices while providing access to beneficial technologies, and were modeled after international standards from the EU and US. Registration requires an application including device details, manufacturing and quality certifications, clinical evidence, and post-market monitoring plans. The process aims to ensure medical devices meet safety and efficacy requirements before approval and sale in the UAE market.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
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.
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
overview of Anvisa Requirements, Medical device classification and grouping, cadostro registration pathway,resgistro pathway,INMETRO Certification, Summary of Anvisa Registration Process
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
The New Drugs and Clinical Trials (Amendment) Rules, 2023. ClinosolIndia
The latest rules for the registry of Clinical Research Organisations (CRO) in India were issued in The New Drugs and Clinical Trials (Amendment) Rules, 2023. These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies.
The registration process requires the CRO to submit an application with all the necessary details about the clinical trial or study, including the name and address of the sponsor, the name and qualifications of the principal investigator, details of the investigational drug, and other relevant information.
Once the application is submitted, the Central Licensing Authority will examine it to ensure that all necessary information has been provided and that the CRO has the necessary infrastructure, personnel, and equipment to conduct the study safely and effectively. If the Authority is satisfied with the application, it will grant registration to the CRO, after which it can conduct the clinical trial or study as per the approved protocol.
These rules are a significant step forward in ensuring the safety and ethical conduct of clinical trials and studies in India, and in providing greater accountability and transparency in the research process.
Medical device and Patency
By MDD 93/42
Any devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
investigation, replacement or modification or support of the anatomy or of a physiological process;
supporting or sustaining life;
disinfection of medical devices; and
control of conception.
What is 510(k) ?
A 510(k) is a premarket submission made to FDA to demonstrate
that the device to be marketed is as safe and effective, that is,
substantially equivalent, to a legally marketed device
(section 513(i)(1)(a) FD&C act).
Medical Devices are notified as DRUGS under Drugs & Cosmetics Act. Section 3 (b) (iv) defines,
Medical Devices as “Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals”
India had no regulation for medical devices in place prior to 2005.
The import, manufacturing, distribution and Sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945)
Control and inspection are carried out by the CDSCO, state drug controllers and central/state laboratories.
Procedure for getting the manufacturing license of notified IVDs Products in ...Mayank Saini
1) The document outlines the procedure for obtaining a manufacturing license for notified in vitro diagnostic (IVD) products in India. It involves submitting an application with documents to the state and central drug authorities, who may request additional information.
2) If approved, joint inspections are conducted by state and central inspectors. If deficiencies are found, corrections must be made and reinspection may occur. Test batches are produced and evaluated.
3) Upon receiving positive evaluation reports and recommendations, the state authority can issue the manufacturing license, which is valid for 5 years. The process generally takes 6-9 months for notified IVDs. Non-notified IVD licenses have fewer requirements.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, medical devices, and clinical trials. CDSCO has headquarters in New Delhi and is overseen by the Drug Controller General of India. It has various zonal and sub-zonal offices that perform GMP audits, inspections, and quality control tests. CDSCO uses a multi-step process to approve clinical trials, drugs, cosmetics, and medical devices that involves submitting documents and gaining permission from the DCGI. It also has an online portal called SUGAM to streamline the application process.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
2- Pre Requirements for registration of MD.pdfssusercbd395
This document provides information on the pre-requirements for registering medical devices in Oman. It discusses medical device definitions, classifications, and categories. It outlines three stages for medical device registration: before importing, during supply/marketing, and after supplying/marketing. For each stage, it lists specific requirements like manufacturer and product authorization, storage licensing, clearance requirements, and commitments around after-sales support, modifications, disposal, and safety reporting. The overall document serves as a guideline for medical device registration in Oman from import to post-market obligations.
English Drug and Alcohol Commissioners June 2024.pptxMatSouthwell1
Presentation made by Mat Southwell to the Harm Reduction Working Group of the English Drug and Alcohol Commissioners. Discuss stimulants, OAMT, NSP coverage and community-led approach to DCRs. Focussing on active drug user perspectives and interests
Emotional and Behavioural Problems in Children - Counselling and Family Thera...PsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
This particular slides consist of- what is Pneumothorax,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
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Certain chemicals, such as phthalates and parabens, can disrupt the body's hormones and have significant effects on health. According to data, hormone-related health issues such as uterine fibroids, infertility, early puberty and more aggressive forms of breast and endometrial cancers disproportionately affect Black women. Our guest speaker, Jasmine A. McDonald, PhD, an Assistant Professor in the Department of Epidemiology at Columbia University in New York City, discusses the scientific reasons why Black women should pay attention to specific chemicals in their personal care products, like hair care, and ways to minimize their exposure.
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2. CHAPTER I
PRELIMINARY
CHAPTER II
ESTABLISHMENT LICENCE
CHAPTER III
CLASSIFICATION AND GROUPING OF MEDICAL
DEVICES
CHAPTER IV
ENLISTMENT AND REGISTRATION OF MEDICAL
DEVICES
CHAPTER V
IMPORT AND EXPORT
CHAPTER VI
LABELLING OF MEDICAL DEVICES
CHAPTER VII
RESPONSIBILITIES AND OBLIGATIONS
CHAPTER VIII
EXEMPTIONS, PROHIBITIONS AND SAMPLING
CHAPTER IX
USAGE, OPERATION, MAINTENANCE, ETC.
CHAPTER X
MEDICAL DEVICE BOARD (MDB)
CHAPTER XI
APPEAL
CHAPTER XII
MEDICAL DEVICE REGISTER
CHAPTER XIII
FEE
CHAPTER XIV
ADVERTISMENT OF MEDICAL DEVICES
CHAPTER XV
MISCELLANEOUS
Agenda / Content
3. CHAPTER II
ESTABLISHMENT LICENCE
Types of establishment licences
The MDB shall issue following types of establishment licensees,
(a) licence to manufacture medical devices; and
(b) license to import medical devices
Application procedure for establishment licence
The application for an establishment licence for manufacturing or import shall, on the format as set:
Form-1 Application for Grant/ Renewal of Establishment Licence to Locally Manufacturer Medical Devices
Form-2 Application for Grant/ Renewal of Establishment Licence to Import Medical Devices
4. Procedure for grant of establishment licence
1.After submission, the MDB shall consider the application and may inspect the premises to
verify any information, particulars, documents and other requirements
2.for this purpose, the MDB may constitute a panel of experts which may include inspectors
or auditors
3.If satisfied with all requirements, the MDB shall issue a licence to the establishment for
manufacturing or import on the format as set out in Form-3 or Form-4
4.Licence will be valid for a period of five years from the date of its issuance
5.And shall be entered in the medical device register (MDR)
CHAPTER II
ESTABLISHMENT LICENCE
5. Renewal of establishment licence
1.An application for renewal of establishment licence for manufacturing or import shall be made sixty
days before its expiry, to the MDB on Form-1 or Form-2 (as the case may be)
2.The MDB may inspect the premises or constitute a panel of experts, include inspectors or auditor
3.The MDB may approve renewal of establishment licence for a period of five years from the date of
expiry of previous licence
4.If an application is made after expiry (but within one year), the applicant shall deposit an additional fee
equivalent to renewal fee for each month
If an application is made after one year, the establishment licence shall cease to exist and the application
shall be treated as a fresh application for grant of establishment licence
CHAPTER II
ESTABLISHMENT LICENCE
6. CHAPTER III
CLASSIFICATION AND GROUPING OF MEDICAL DEVICES
For the purpose of registration and enlistment, the method of classification and grouping
of medical devices shall be in accordance with Schedule A and B respectively,
CLASSIFICATION SYSTEM FOR MEDICAL DEVICES - Schedule A
(a) MDB should establish a device classification system consisting of four classes where Class A represents the lowest
hazard and Class D the highest.
CLASS LEVEL DEVICE EXAMPLES
A Low Hazard tongue depressors/ disposable masks
B Low-moderate Hazard Hypodermic Needles / suction equipment
C Moderate-high Hazard Lung ventilator / bone fixation plate
D High Hazard Heart valves / implantable defibrillator
7. GROUPING OF MEDICAL DEVICES - Schedule B
General principles of grouping.
1.For the purpose of registration, the medical devices shall be grouped in accordance with these
methods of grouping.
2.Medical devices may be grouped into one of the following categories, namely:
3.single
4.family
5.system
6.set
7.in-vitro test kit
8.in-vitrocluster.
3. The basic methods of grouping consist of the following, namely:—
a)one generic proprietary name
b)one manufacturer; and
c)one common intended purpose
8. CHAPTER IV
ENLISTMENT AND REGISTRATION OF MEDICAL DEVICES
12. Enlistment and registration of medical devices
The MDB shall enlist and register medical devices which include any instrument, apparatus,,
machine, appliance, implant, reagent for in-vitro use, software, material or other similar or
related article, intended by the manufacturer to be used, alone or in combination, for human
beings or animals for one or more of the specific medical purposes of —
(a) diagnosis, prevention, monitoring, treatment or alleviation of disease;
(b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
(c) investigation, replacement, modification or support of the anatomy or of a physiological
process;
(d) supporting or sustaining life;
(e) control of conception;
(f) disinfection of medical devices; or
(g) providing information by means of in-vitro examination of specimens derived from the
human body,
9. 13. Classes of medical devices for enlistment and registration, (1) The MDB shall issue
following types of medical devices enlistment and registration, namely:—
(a) Enlistment of Class A medical devices and
(b) Registration for Class B, C and D medical devices
14. Procedure for enlistment and registration of medical devices, (1) An application for
enlistment or registration of a medical device shall be made by—
(a) An establishment having valid licence to manufacture medical devices; or
(b) An importer in his capacity as authorized representative in Pakistan having valid
establishment licence.
Enlistment of Class A
Local – Form 6
Imported – Form 6A
Registration of Class B, C & D
Local – Form 7
Imported – Form 7A
Complete labelling and prescribing information shall be same as approved in the country of
origin or as approved in European Union, USA, Japan, Canada or Australia.
CHAPTER IV
ENLISTMENT AND REGISTRATION OF MEDICAL DEVICES
10. 15. Procedure for grant of certificate for enlistment or registration of medical device
1)Upon receipt of the application, the MDB may inspect the premises of the establishment. Through a panel of experts
which may include inspectors or auditors. However, such inspection shall be exempt for the countries as specified
2)USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain,
Sweden, Switzerland and United Kingdom or pre-qualified by World Health Organization.
3)If the MDB is satisfied with all requirements, it shall enlist and register the medical device and enter it in the medical
device register.
4)The enlistment or registration shall be for a period of five years from the date of enlistment or registration, as the case
may be, unless it is cancelled or suspended by the MDB before its expiry
5)The MDB shall assign an enlistment and registration number and issue a certificate of enlistment and registration
FORM-8
CERTIFICATE OF ENLISTMENT OR REGISTRATION OF A MEDICAL DEVICE OR ACCESSORY OR COMPONENT FOR LOCAL
MANUFACTURE
FORM-8A
CERTIFICATE OF ENLISTMENT OR REGISTRATION OF A MEDICAL DEVICE OR ACCESSORY OR COMPONENT FOR IMPORT
6) If application rejected by the MDB, it shall inform the applicant about its decision in writing with reasons of such
decision
CHAPTER IV
ENLISTMENT AND REGISTRATION OF MEDICAL DEVICES
11. 16. Renewal of certificate for enlistment and registration of medical device
An application for renewal of enlistment and registration for local manufacture or import shall be made
Renewal of Enlistment of Class A
Local – Form 6
Imported – Form 6A
Renewal of Registration of Class B, C & D
Local – Form 7
Imported – Form 7A
Application fee as specified in rule 63;
The MDB may inspect the premises or constitute a panel of experts, include inspectors or auditor
If an application is made after expiry (but within one year), the applicant shall deposit an additional fee equivalent
to renewal fee for each month till one year
After one-year, the enlistment or registration, shall cease to exist and shall be treated as a fresh application
If an application for renewal is made before expiry or within one year, it shall continue to be valid until orders are
passed on such application.
The renewal certificate shall be granted on the following format
FORM-8
CERTIFICATE OF ENLISTMENT OR REGISTRATION OF A MEDICAL DEVICE OR ACCESSORY OR COMPONENT FOR
LOCAL MANUFACTURE
FORM-8A
CERTIFICATE OF ENLISTMENT OR REGISTRATION OF A MEDICAL DEVICE OR ACCESSORY OR COMPONENT FOR
IMPORT
12. CHAPTER VI
LABELLING OF MEDICAL DEVICES
38. General provisions of labelling of medical devices
(1) No person shall
(a)Place any medical device in the market unless it has been appropriately labeled with
• Establishment-license’s details
• Enlistment or registration number
• MRP
(2) If a medical device has either not been appropriately labeled, or partially labeled, the importer may request MDB to
comply with these rules by printing the information at establishment‘s licensed premises.
(3) The importer, in special cases where the strict application of the labelling is impractical or may impact the quality and
safety, may obtain exemption from the labelling requirements.
(4) The label of a medical device shall be readable, permanent and prominent
39. Location of labelling of medical devices,—
•Shall be appropriately located depending medical device and its intended use
•Where feasible, the label shall be provided on or it be attached to the medical device itself
•If unfeasible, the label shall be provided on the packaging of the individual medical device;
40. Format of labelling of medical devices
The format of labelling shall be in accordance with the international standards for medical device‘s labelling.
41. Language used for labelling of medical devices,
Shall be English, however, the use of Urdu language shall be required for home used medical devices
13. 42. General contents of labelling of medical devices,
The label of a medical device shall contain the following information, namely:
(a)Name
Model if any
Lot or batch or serial number
Enlistment or registration number
Date of manufacturing
Date of expiry
Maximum retail price (MRP) fixed by the manufacturer
(b) Name and complete address of the manufacturer, his licence number, for Imported, also the name and
complete address of importer or authorized representative
(c) Technical details concerning the medical device
(d) Description and intended use of the medical device
(e) Instructions for use of the medical device
(f) Any side effects, limitations, warnings and precautions on the safe use of the medical device
(g) Any necessary post-market servicing needs for the medical device
(h) Any decommissioning or disposal information
(i) Storage or handling.
14. 49. Post-marketing surveillance and vigilance system
A licensee shall establish, maintain and implement an appropriate and effective
post-marketing surveillance and vigilance system of medical devices, which shall
include the following elements, namely
(a) Distribution records;
(b) Complaint handling system;
(c) Mandatory problem reporting, including investigation of problem or incident;
(d) Field corrective action; and
(e) Recall procedure.
15. CHAPTER VIII
EXEMPTIONS, PROHIBITIONS AND SAMPLING
Exemption from operation of the rules
Sr.No. Establishment and class of medical devices Exemption period
1. Import and manufacturing establishments 6 months
2. Class D medical devices 9 months.
3. Class C medical devices 12 months.
4. Class B medical devices 18 months.
5. Class A medical devices 24 months.
The establishment shall on the Form-19, make application to the MDB along with original valid
agency agreement from medical-device-market-authorization-holder for grant of provisional
establishment certificate.
Chairman MDB shall decide application within seven working days for grant of provisional
establishment certificate (in Form-20) which shall be valid till the date of validity of exemption
period
After that an application to the MDB for the grant of provisional enlistment or registration of medical
device is made
The Chairman MDB shall decide and grant provisional enlistment or registration certificate (in Form-22)
which shall be valid till the date of validity of exemption periods
No life saving or life sustaining medical devices specified in Schedule-D shall be imported, sold and
used unless such medical devices are imported from the sources specified (
reference countries)
16. 53. Fabrication of custom-made medical devices, (1) No person shall fabricate a custom-made medical
device, unless that person
•is a qualified person for the use of patient under his care
•fabricates a custom-made medical device for:
(i) hospital, medical clinic, dental clinic or health clinic
(ii) private healthcare facility
54. Sampling of medical device for testing, (1) The MDB may, at any time in writing, ask establishment
for the samples of enlisted or registered medical for appropriate analysis or testing.
(2) Any expense incurred for the sampling, testing or analysis of the medical devices shall be borne by
the establishment
17. CHAPTER X
MEDICAL DEVICE BOARD (MDB)
The MDB consist of 15 members in total
1 Director Chairman
Shaikh Akhtar
Hussain
1 Additional director Member-cum-Secretary Dr. Ghazanfar
5-Apr Director General Health Member
2
Pharmacists having relevant
experience
Member
1 Biomedical engineer Member
1 Radiologist Member
1
software or electromechanical engineer
Member
1 General or orthopedic surgeon Member
1 Cardiovascular surgeon Member
1 Hospital pharmacist Member
1 Pathologist or medical technologist Member
Assistant Directors: 1.
Hira Bhutto
2. Dr. Anum
3. Hafiz Asif Iqbal
4. Ayub
18. CHAPTER XI
APPEAL
Appeal against decision of the MDB , person or party may prefer appeal
before the Appellate Board against the decision of MDB within a period of
sixty days.
19. CHAPTER XII
MEDICAL DEVICE REGISTER
The MDB shall maintain separate registers for
•Enlisted or registered medical devices
•Establishments licensed and
•Decisions of the MDB
20. CHAPTER XIII
FEE
ESTABLISHMENT LICENCES
Local manufacturing 100,000
Import 20,000
Renewal of establishment licence - Local 50,000
Renewal of establishment licence - Import 10,000
Note: Fee for change in particulars of licensed establishment shall be fifty percent of the licensing fee.
Schedule C for Fee