China has established a China Compulsory Certification (CCC) system for medical devices that is similar to international fifth party certification models. The CCC system requires type testing, initial factory inspections, and follow up inspections. It covers 7 categories of medical devices including medical x-ray equipment, hemodialysis equipment, artificial heart-lung machines, implantable cardiac pacemakers, electrocardiographs. Standards are based on transformed international IEC standards and national standards. The certification process involves application, testing, factory inspection, evaluation, and issuing of certificates. Follow up inspections ensure continued compliance.
2018 Annual Report on China Medical Device RegulationsCIRS China
The annual report summarizes China's medical device regulatory environment and market in 2018. Some key points:
- China approved 206 innovative medical devices in 2018, with 185 produced domestically.
- The NMPA issued numerous regulatory updates, including proposed revisions to the Medical Device Supervision Regulations to reform clinical trials and registration pathways.
- Trends for 2019 include full implementation of the marketing authorization holder system, adjustments to the medical device classification system, and strengthened post-market supervision.
The Cardiovascular Monitoring System is a portable home monitoring device that measures blood pressure, heart rate, and blood oxygen levels during exercise. It consists of a finger monitor, display monitor, and physician programming software. The finger monitor uses the same blood pressure and pulse oximetry measurement techniques as previously cleared devices. The display monitor stores and transmits data to a physician. Non-clinical testing showed the device is safe and performs equivalently to predicate devices. Clinical studies further demonstrated substantial equivalence.
The document summarizes the regulation of in vitro diagnostic (IVD) medical devices in Australia. It outlines the regulatory framework, classification system, conformity assessment process, and key aspects of an inclusion application for IVD devices to be entered into the Australian Register of Therapeutic Goods (ARTG). The summary highlights that IVD devices are regulated under the Therapeutic Goods Act and must comply with essential principles, be appropriately classified, and have evidence of conformity assessment submitted with ARTG applications, which may be subject to audit.
This document describes the CardioQ-EDM+ hemodynamic monitoring system. It combines Doppler measurement of blood flow (flow monitoring mode) with pulse pressure waveform analysis (pressure monitoring mode) to measure both flow and pressure directly. This allows for a proven flow-based mode to guide intervention and a simply calibrated continuous pressure-based mode for extended monitoring. It is the first monitoring system to integrate these two measurement techniques.
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
Regulatory approval process for invitro diagnostics in usVinod Raj
This document summarizes the regulatory approval process for in vitro diagnostics (IVDs) in the United States. IVDs are classified into Class I, II, or III based on risk, with Class III devices requiring premarket approval. The main regulatory pathways for approval are 510(k) premarket notification for demonstrating substantial equivalence to a predicate device or the premarket approval (PMA) process for novel high-risk devices. Clinical Laboratory Improvement Amendments also provide quality standards for lab testing. The document reviews the classification system and options for 510(k), PMA, de novo, and lab developed tests.
The regulation of medical devices in AustraliaTGA Australia
The regulation of medical devices in Australia involves classifying devices based on their intended use and risk level. Higher risk devices undergo more rigorous assessment procedures to ensure they meet essential safety and performance principles before being approved for market. Ongoing monitoring is also conducted after devices enter the market to protect public health. The TGA regulates medical devices to confirm they are suitable for their intended purpose and that their benefits outweigh any risks when used correctly.
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
2018 Annual Report on China Medical Device RegulationsCIRS China
The annual report summarizes China's medical device regulatory environment and market in 2018. Some key points:
- China approved 206 innovative medical devices in 2018, with 185 produced domestically.
- The NMPA issued numerous regulatory updates, including proposed revisions to the Medical Device Supervision Regulations to reform clinical trials and registration pathways.
- Trends for 2019 include full implementation of the marketing authorization holder system, adjustments to the medical device classification system, and strengthened post-market supervision.
The Cardiovascular Monitoring System is a portable home monitoring device that measures blood pressure, heart rate, and blood oxygen levels during exercise. It consists of a finger monitor, display monitor, and physician programming software. The finger monitor uses the same blood pressure and pulse oximetry measurement techniques as previously cleared devices. The display monitor stores and transmits data to a physician. Non-clinical testing showed the device is safe and performs equivalently to predicate devices. Clinical studies further demonstrated substantial equivalence.
The document summarizes the regulation of in vitro diagnostic (IVD) medical devices in Australia. It outlines the regulatory framework, classification system, conformity assessment process, and key aspects of an inclusion application for IVD devices to be entered into the Australian Register of Therapeutic Goods (ARTG). The summary highlights that IVD devices are regulated under the Therapeutic Goods Act and must comply with essential principles, be appropriately classified, and have evidence of conformity assessment submitted with ARTG applications, which may be subject to audit.
This document describes the CardioQ-EDM+ hemodynamic monitoring system. It combines Doppler measurement of blood flow (flow monitoring mode) with pulse pressure waveform analysis (pressure monitoring mode) to measure both flow and pressure directly. This allows for a proven flow-based mode to guide intervention and a simply calibrated continuous pressure-based mode for extended monitoring. It is the first monitoring system to integrate these two measurement techniques.
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
Regulatory approval process for invitro diagnostics in usVinod Raj
This document summarizes the regulatory approval process for in vitro diagnostics (IVDs) in the United States. IVDs are classified into Class I, II, or III based on risk, with Class III devices requiring premarket approval. The main regulatory pathways for approval are 510(k) premarket notification for demonstrating substantial equivalence to a predicate device or the premarket approval (PMA) process for novel high-risk devices. Clinical Laboratory Improvement Amendments also provide quality standards for lab testing. The document reviews the classification system and options for 510(k), PMA, de novo, and lab developed tests.
The regulation of medical devices in AustraliaTGA Australia
The regulation of medical devices in Australia involves classifying devices based on their intended use and risk level. Higher risk devices undergo more rigorous assessment procedures to ensure they meet essential safety and performance principles before being approved for market. Ongoing monitoring is also conducted after devices enter the market to protect public health. The TGA regulates medical devices to confirm they are suitable for their intended purpose and that their benefits outweigh any risks when used correctly.
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
The document discusses medical device regulation, including:
- Why regulation is needed due to past issues like thalidomide
- The definition of a medical device and what is/isn't included
- An overview of the regulatory framework and requirements in countries like Australia, Europe, and the US
- Key parts of the regulatory process include classifying devices based on risk, meeting regulatory requirements through conformity assessments, maintaining quality management systems, and providing technical documentation
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Regulation of IVD medical devices - presentation at National Histotechnology ...TGA Australia
The document discusses regulations for in vitro diagnostic (IVD) medical devices in Australia. It provides an overview of the current regulatory framework, which implemented a new four-tier classification system in 2010 based on risk. All commercial IVDs and high-risk in-house IVDs must be included in the Australian Register of Therapeutic Goods. The document announces reforms planned for 2015 to simplify requirements for certain in-house IVDs and provides guidance for laboratories on identifying devices and complying with regulations by 2017 deadlines.
This document provides an in-depth analysis of the ultrasound market including key details about ultrasound systems, technologies, clinical applications, major industry players, market trends, and global market size and forecasts. Specifically, it surveys almost all companies marketing ultrasound equipment worldwide, discusses each in depth, and includes detailed tables and charts on sales forecasts, market share, and more.
Hybrid operating rooms (ORs) allow both minimally invasive surgeries and open procedures to be performed using imaging guidance in the same room. This enables more patients to undergo less invasive surgeries. Key considerations in designing a hybrid OR include determining the imaging system and equipment needed based on planned procedures, allocating sufficient space, and ensuring staff are properly trained on the new environment and equipment. Common hybrid ORs feature angiography, CT, or MRI systems to provide real-time imaging guidance during surgeries.
A failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true:
1. The chance of a death or serious injury
2.The malfunction affect the device in a catastrophic manner that may lead to a death or serious injury
3. The device fail to perform its essential function
4. The malfunction would be likely to cause or contribute to death or serious injury, regardless of how the device is used.
The document provides an introduction and guidelines for testing vital signs monitoring equipment. It describes the physiology of the respiratory system and circulation. It then discusses testing various vital signs monitoring functions, including non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulse oximetry (SpO2), electrocardiography (ECG), respiration, and temperature. The guidelines provide information on test setup and procedures for evaluating the accuracy, alarms, sensitivity and other performance characteristics of the monitoring equipment. Regular performance testing is recommended to ensure the equipment continues to provide accurate vital sign measurements.
Device Sponsor Information Day: Session 4B: Medical Devices (IVDs) - applicat...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
Why to conduct clinical trials in Ukraine? Ukrainian CRODariaAbulova
- Why to conduct clinical trials in Ukraine?
- Who we are - JERELO CRO
- Area of expertise of JERELO
- Cardio surgery case of JERELO CRO
- Stages of MD lifecycle and our facilities for clinical researches on its every stage
- Regulatory services and services of the Authorized Representative in Ukraine
All these issues are described in our presentation.
JERELO is your reliable CRO in Ukraine.
FDA GUIDANCE: Oversight Of Clinical Investigations Risk Based Approach To Mon...crr99999
This draft FDA guidance provides recommendations for using a risk-based approach to monitoring clinical investigations. It encourages sponsors to focus monitoring on critical data and processes, and to use centralized monitoring where appropriate in addition to on-site monitoring. The guidance aims to enhance human subject protection and data quality in clinical trials by making it clear that sponsors have flexibility in designing monitoring strategies.
Pharma leader series top stem cell technology companies 2015 2025Visiongain
For an Executive Summary of this report please contact ben.suntivarakom@visiongain.com
(+44 (0)20 7549 9976)
or refer to our website: http://goo.gl/bhNICQ
COMBINATION PRODUCTS – Perspectives on FDA RegulationMichael Swit
Overview of FDA regulation of combination products -- those featuring a drug and a device, a device and a biologic, or a biologic and a drug. Reviews key issues such as Primary Mode of Action, Requests for Designation, and how to handle GMPs and Adverse Event Reporting for combination products.
regulation for combination product and medical devicesSNEHADAS123
The document discusses regulations for combination products and medical devices. It begins by providing context on the pharmaceutical industry and need for regulations. Key points include:
- Combination products contain both a drug and medical device component. The FDA assigns a lead center for review based on the primary mode of action.
- Medical devices are defined and examples of products classified as drugs or devices are given. Software can be considered a medical device.
- Regulations provide a framework for safe, effective and quality products. Major regulatory bodies and pathways like 510(k) and PMA are outlined for the US, EU, and India. Recent developments aim to strengthen regulations in India.
1) Completing an AiS Challenge project is time consuming and intellectually challenging, so working in teams allows people to use their combined skills, sustain enthusiasm, and support one another to complete the project.
2) Teams work best when members are committed to common objectives, have defined roles and responsibilities, and effective communication, decision-making, and work procedures.
3) Successful teams go through forming, storming, norming, and performing stages where they establish roles and goals, work through conflicts, develop norms and understanding, and become high-performing.
The document discusses medical device regulation, including:
- Why regulation is needed due to past issues like thalidomide
- The definition of a medical device and what is/isn't included
- An overview of the regulatory framework and requirements in countries like Australia, Europe, and the US
- Key parts of the regulatory process include classifying devices based on risk, meeting regulatory requirements through conformity assessments, maintaining quality management systems, and providing technical documentation
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Regulation of IVD medical devices - presentation at National Histotechnology ...TGA Australia
The document discusses regulations for in vitro diagnostic (IVD) medical devices in Australia. It provides an overview of the current regulatory framework, which implemented a new four-tier classification system in 2010 based on risk. All commercial IVDs and high-risk in-house IVDs must be included in the Australian Register of Therapeutic Goods. The document announces reforms planned for 2015 to simplify requirements for certain in-house IVDs and provides guidance for laboratories on identifying devices and complying with regulations by 2017 deadlines.
This document provides an in-depth analysis of the ultrasound market including key details about ultrasound systems, technologies, clinical applications, major industry players, market trends, and global market size and forecasts. Specifically, it surveys almost all companies marketing ultrasound equipment worldwide, discusses each in depth, and includes detailed tables and charts on sales forecasts, market share, and more.
Hybrid operating rooms (ORs) allow both minimally invasive surgeries and open procedures to be performed using imaging guidance in the same room. This enables more patients to undergo less invasive surgeries. Key considerations in designing a hybrid OR include determining the imaging system and equipment needed based on planned procedures, allocating sufficient space, and ensuring staff are properly trained on the new environment and equipment. Common hybrid ORs feature angiography, CT, or MRI systems to provide real-time imaging guidance during surgeries.
A failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true:
1. The chance of a death or serious injury
2.The malfunction affect the device in a catastrophic manner that may lead to a death or serious injury
3. The device fail to perform its essential function
4. The malfunction would be likely to cause or contribute to death or serious injury, regardless of how the device is used.
The document provides an introduction and guidelines for testing vital signs monitoring equipment. It describes the physiology of the respiratory system and circulation. It then discusses testing various vital signs monitoring functions, including non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulse oximetry (SpO2), electrocardiography (ECG), respiration, and temperature. The guidelines provide information on test setup and procedures for evaluating the accuracy, alarms, sensitivity and other performance characteristics of the monitoring equipment. Regular performance testing is recommended to ensure the equipment continues to provide accurate vital sign measurements.
Device Sponsor Information Day: Session 4B: Medical Devices (IVDs) - applicat...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
Why to conduct clinical trials in Ukraine? Ukrainian CRODariaAbulova
- Why to conduct clinical trials in Ukraine?
- Who we are - JERELO CRO
- Area of expertise of JERELO
- Cardio surgery case of JERELO CRO
- Stages of MD lifecycle and our facilities for clinical researches on its every stage
- Regulatory services and services of the Authorized Representative in Ukraine
All these issues are described in our presentation.
JERELO is your reliable CRO in Ukraine.
FDA GUIDANCE: Oversight Of Clinical Investigations Risk Based Approach To Mon...crr99999
This draft FDA guidance provides recommendations for using a risk-based approach to monitoring clinical investigations. It encourages sponsors to focus monitoring on critical data and processes, and to use centralized monitoring where appropriate in addition to on-site monitoring. The guidance aims to enhance human subject protection and data quality in clinical trials by making it clear that sponsors have flexibility in designing monitoring strategies.
Pharma leader series top stem cell technology companies 2015 2025Visiongain
For an Executive Summary of this report please contact ben.suntivarakom@visiongain.com
(+44 (0)20 7549 9976)
or refer to our website: http://goo.gl/bhNICQ
COMBINATION PRODUCTS – Perspectives on FDA RegulationMichael Swit
Overview of FDA regulation of combination products -- those featuring a drug and a device, a device and a biologic, or a biologic and a drug. Reviews key issues such as Primary Mode of Action, Requests for Designation, and how to handle GMPs and Adverse Event Reporting for combination products.
regulation for combination product and medical devicesSNEHADAS123
The document discusses regulations for combination products and medical devices. It begins by providing context on the pharmaceutical industry and need for regulations. Key points include:
- Combination products contain both a drug and medical device component. The FDA assigns a lead center for review based on the primary mode of action.
- Medical devices are defined and examples of products classified as drugs or devices are given. Software can be considered a medical device.
- Regulations provide a framework for safe, effective and quality products. Major regulatory bodies and pathways like 510(k) and PMA are outlined for the US, EU, and India. Recent developments aim to strengthen regulations in India.
1) Completing an AiS Challenge project is time consuming and intellectually challenging, so working in teams allows people to use their combined skills, sustain enthusiasm, and support one another to complete the project.
2) Teams work best when members are committed to common objectives, have defined roles and responsibilities, and effective communication, decision-making, and work procedures.
3) Successful teams go through forming, storming, norming, and performing stages where they establish roles and goals, work through conflicts, develop norms and understanding, and become high-performing.
The document contains a collection of short quotes and sayings about topics like confidence, success, wisdom, relationships, positivity, and living life to the fullest. Some of the key messages expressed are: gain confidence through practice; think positively and creatively solve challenges; be honest, diligent, and work continuously toward your goals; and make the most of each day as a gift.
The document discusses achieving success through the review process. It has two main aims: to provide an understanding of the review process and to introduce the SMART approach to objective setting. The review process benefits both individuals and the university by clarifying expectations, improving communication, and celebrating successes. It also discusses different levels of objectives, the annual review cycle, roles and responsibilities, examples of SMART objectives, receiving feedback, and types of development.
The document discusses succession planning for key leadership positions. It defines succession planning as identifying and developing internal talent for senior roles. An effective succession plan involves setting goals, identifying successors, developing successors through training and mentoring, and communicating the transition when it occurs. The plan should be led by current leadership and overseen by the board of directors to ensure continuity and strong governance.
China Compulsory Certification Requirement And Procedures Of Medical DeviceJacobe2008
China has a compulsory certification (CCC) requirement for medical devices that went into effect in May 2002. There are 7 categories of devices that require CCC, including medical x-ray equipment, hemodialysis equipment, artificial heart-lung machines, implantable cardiac pacemakers, and electrocardiographs. The CCC process involves type testing, initial factory inspections, and follow-up inspections. Standards are based on translated international IEC standards and certification follows a typical international model of type testing plus initial and follow-up factory audits. Information about CCC, standards, and the certification process is publicly available on government websites.
Abbott overview medical device human factors standardsJones Wu
The document provides an overview of international medical device human factors standards, outlining their history and purposes. It summarizes that IEC 62366:2007 is now the key usability engineering standard, with IEC 60601-1-6:2010 pointing to it, and HE-74 being incorporated into IEC 62366 as an annex. Future revisions are planned to split and update IEC 62366 by 2014 to address additional topics and harmonize with FDA guidance.
The Biomedical Engineering department will provide full services for medical devices and systems, excluding major radiation equipment. Services include acceptance testing of new equipment, installation, maintenance, training, and a risk management program. The department needs office and workshop space with durable surfaces, task lighting, and connections for gases and electricity at workstations. Staff will include 7 technicians, a manager, and clerk.
EU Commission’s Draft Standardization RequestEMMAIntl
The EU MDR and the IVDR layout the performance and safety requirements for medical devices and In-vitro diagnostics respectively in the EU. According to Article 8 of the EU MDR and the IVDR, manufacturers that comply with the harmonized standards are presumed to conform to the requirements of the European regulations.
In the past, based on several standardization mandates issued by the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) have drafted harmonized standards in support of MDD and IVDD. The EU Commission is now proposing the revision of these harmonized standards to take into account the requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746 and help ensure a high level of public safety and to facilitate free movement of devices in the EU Union...
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
The document discusses the new IVD Medical Device Act in Korea and its impact on the Korean IVD industry. It provides a history of IVD regulations in Korea and an overview of the key aspects of the new Act, which was enacted in April 2019 and will be enforced starting May 2020. The new Act establishes a risk-based classification system for IVD devices and requirements for clinical laboratory accreditation for IVD testing. It is expected to harmonize Korean regulations with international standards and reduce regulatory burden through changes like a negative system for product changes.
This document discusses emerging FDA regulations and guidance related to medical device labeling during the COVID-19 pandemic. It provides details on recommended modifications to indications, functionality and labeling for several device types including remote ophthalmic devices, sterilizers, disinfectants, air purifiers, infusion pumps and face masks/respirators. The recommendations aim to expand device capabilities and environments of use while ensuring adequate instructions and safety information are provided in labeling.
Legal and regulatory developments in precision medicine and diagnostic devicesErik Vollebregt
The document discusses new regulations for precision medicine and diagnostic devices in Europe under the In Vitro Diagnostic Regulation (IVDR) and General Data Protection Regulation (GDPR). Key points include:
- The IVDR brings much higher standards for performance evaluation and clinical evidence compared to previous regulations. It requires use of personal health data, subject to GDPR rules.
- The GDPR requires strict consent and security protocols for use of personal data in performance studies and evaluations. Secondary use of data for research is allowed with safeguards.
- Implementation of both regulations together poses challenges around increased data requirements and protection of personal information. Notified bodies will see a large workload increase for device reviews.
The document discusses labeling requirements and changes for medical devices during the COVID-19 pandemic. It provides guidance on modifications allowed for remote assessment devices, sterilization equipment, disinfectants, and air purifiers. The guidance includes recommended labeling changes to clearly describe new intended uses and functions, performance data, and potential risks. It also provides standards and studies manufacturers should follow to demonstrate safety and effectiveness for things like UV light disinfection or air filtration claims.
AtharBuchheitHussein-A3-EU PLAN REGULATORY STRATEGYScott Buchheit
This 3-page document provides a regulatory strategy for obtaining CE marking and marketing approval for an implantable bone screw in the European Union. It outlines the key deliverables, timelines, and conformity assessment process. The strategy involves obtaining ISO 13485 certification, submitting a technical file including clinical data to a Notified Body for approval, and CE marking once all requirements are met to allow marketing in EU countries.
Educo Life Science [gathering clinical evidence] [module 1]Ali Abu
The slide are solely prepared by Educo Life Science
Module 1 will cover the following:
Regulatory, guidance and standards for gathering medical device clinical evidence
>How does the regulation apply to gathering of clinical evidence
>What guidance and standard documents need to be followed when gathering clinical evidence
>Clinical evidence for different device classes and the procedures relative to each
>What data, when, why, and how
>Clinical definitions and terminology
The document discusses upcoming changes to the IEC 60601 standards for medical device safety and performance. Key points include:
- IEC 60601-1 3rd Edition is expected to be published in late 2005, establishing risk management and identifying essential performance as requirements.
- Essential performance is performance necessary to avoid unacceptable risk. Manufacturers will identify which functions are essential.
- IEC 60601-1-2 for electromagnetic compatibility now requires testing essential performance and has expanded immunity test levels.
Medical devices play a crucial role in modern healthcare, encompassing a vast array of instruments, equipment, implants, and software used for diagnosis, treatment, monitoring, and rehabilitation. From simple tools like thermometers and stethoscopes to complex devices such as MRI machines and pacemakers, medical devices contribute to improving patient outcomes, enhancing quality of life, and advancing medical innovation. In this discussion, we explore the significance, types, regulation, challenges, and future trends of medical devices.
First and foremost, medical devices are indispensable assets in healthcare delivery, enabling clinicians to diagnose diseases, perform procedures, and manage patient care effectively. Diagnostic devices, including X-ray machines, ultrasound scanners, and blood glucose monitors, provide critical information for accurate diagnosis and treatment planning. Therapeutic devices, such as ventilators, defibrillators, and prosthetic limbs, aid in managing acute and chronic conditions, restoring function, and alleviating symptoms. Monitoring devices, such as cardiac monitors, continuous glucose monitors, and wearable fitness trackers, facilitate real-time assessment of patient health and enable early intervention when necessary. Additionally, surgical instruments, implants, and assistive devices enhance surgical precision, promote tissue repair, and improve mobility and independence for individuals with disabilities.
The landscape of medical devices is diverse and constantly evolving, encompassing a wide range of technologies and applications. Common categories include diagnostic imaging devices, in vitro diagnostic (IVD) devices, surgical instruments, dental equipment, orthopedic implants, cardiovascular devices, ophthalmic devices, and more. Furthermore, advances in digital health technologies have led to the development of connected medical devices, telemedicine platforms, health monitoring apps, and wearable sensors, revolutionizing the delivery of healthcare services and empowering patients to take an active role in their health management.
Given the critical role they play in patient care, medical devices are subject to stringent regulation to ensure safety, efficacy, and quality standards. In the United States, the Food and Drug Administration (FDA) oversees the regulation of medical devices through a comprehensive framework that includes premarket approval, post-market surveillance, quality systems regulation, and adverse event reporting. Similarly, regulatory bodies in other countries, such as the European Union's CE marking system and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), enforce standards and requirements to ensure the safety and effectiveness of medical devices sold in their respective markets.
Despite their numerous benefits, medical devices also present certain challenges and considerations. These include concerns related to device interoperability and integration with healthcare
Neuro-Stim System Neurostim FDA K140530 Electro Acupuncture Devicemcalipo
Neuro-Stim Electro Acupuncture device and Electro Acupuncture Stimulator. The Electro Auricular Device or PENS (Percutaneous Electrical Nerve Stimulation). Neurostimulation pain therapy medical devices deliver a therapeutic electrical signal into auricular nerves to help release endorphins and provide pain relief.
https://www.laserspineinstitute.com/spinal_orthopedic_procedures/neurostim/
ZMPCZM016000.13.03 Certificate of compliancepainezeeman
The Certificate of Compliance certifies that the Zynex Medical NexWave TENS unit was tested and found to comply with IEC 60601-1 and IEC 60601-2-10 standards. The NexWave is a portable TENS unit that can be powered by an internal battery or external power supply and has two independent stimulation channels to apply electrical stimulation to skin sites via electrode pads. Compliance testing was performed by Compliance Integrity Services and the NexWave was
Speed your time to market by following the step-by-step instructions.
You'll learn the steps to success for product testing by a certification agency (like UL, TÜV, BSI, Intertek, etc.) to the IEC 60601-1 series of standards on medical electrical equipment and systems.
See the mistakes others have made that have slowed down their certification process (and how you can avoid them).
Take proactive steps so your product doesn’t need to get redesigned after testing starts.
Specifically, you will learn:
-The scope of IEC 60601-1 standards & if they apply to your product.
-What you need to know to classify your products to the IEC 60601-1 series.
-What is an isolation diagram and how does that help me with my design?
-Determine the applicable tests for your device.
-What are the marking and labeling requirements for the device?
-Know your critical components.
-What pre-tests to run and what’s not worth testing?
-Resources to help with this process and ways to reduce the paperwork off your backs.
Watch the presentation here: https://www.greenlight.guru/webinar/iec-60601-1
Presentation: Conformity assessment evidenceTGA Australia
An overview of Conformity Assessment requirements and General Safety and Performance Requirements and demonstrating compliance in the Australian context.
This document provides an overview of medical devices:
It defines medical devices as instruments used for medical purposes like diagnosis and treatment. The history section outlines important medical device innovations from the late 19th century to present. Regulations for medical devices are described, including organizations that regulate quality, safety and efficacy. Medical devices are classified based on their risks. The document discusses the drug development process, therapeutic and diagnostic uses of devices, risks, and concludes that benefits generally outweigh risks when proper risk management is followed.
Presentation on what it takes to get a clinical study off the ground in the UK along with some info on the impact of directive 2007/47/EC will have on clinical data requirements
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
Similar to China Compulsory Certification Requirement And Procedures Of Medical Device (20)
Federal Regulatory Issues Us Food And Drug Administration Medical Device Amen...Jacobe2008
Authors:
Harvard-MIT Division of Health Sciences and Technology HST.535: Principles and Practice of Tissue Engineering Instructors: Myron Spector
Massachusetts Institute of Technology
Harvard Medical School Brigham and Women's Hospital VA Boston Healthcare
This document discusses risk management for medical devices. It defines key risk management terms and concepts. The risk management process involves risk assessment, analysis, evaluation, and control. Risk assessment tools include risk matrices, preliminary hazard analysis, fault tree analysis, failure mode and effects analysis, and hazard and operability analysis. Medical device risk management aims to ensure patient, user, and handler safety, as well as manage business and regulatory risks.
This document discusses medical device administration in China. It outlines the competent authorities that regulate medical devices, including the SFDA and Center for Medical Device Evaluation. It also describes the administration activities like registration, production, sales, and post-marketing surveillance. The document then summarizes the laws and regulations regarding medical devices and classifies medical devices into three categories based on risk. It provides details on administration of production, sales, and registration of medical devices in China.
Medical Device Regulations Global Overview And Guiding PrinciplesJacobe2008
WHO Library Cataloguing-in-Publication Data
World Health Organization.
Medical device regulations : global overview and guiding principles.
1.Equipment and supplies – legislation 2.Equipment and supplies –
standards 3.Policy making 4.Risk management 5.Quality control I.Title.
ISBN 92 4 154618 2 (NLM Classification: WA 26)
This document provides an overview of Japan's healthcare system and medical device market. It summarizes that Japan has universal healthcare coverage for its 127 million citizens, with total healthcare expenditures of $278 billion in 2000. The medical device market in Japan was worth $18 billion in 2000, with the United States having a large trade surplus of $4 billion in medical device exports to Japan. The regulatory system for medical devices is administered by the Ministry of Health and requires government approval and licensing for devices to be sold in Japan.
Statistical Issues In Medical Device TrialsJacobe2008
Authors:
George Koustenis,
FDA-CDRH
David Breiter,
Boston Scientific
Roseann White,
Abbott Vascular
George Woodworth, Univ. of Iowa
FDA/INDUSTRY STATISTICS WORKSHOP: Washington, D.C. Sept. 29, 2006
This document provides an overview of safety, WEEE-RoHS, and EMC compliance requirements for electronic products being sold in various markets. It discusses regulations in the US, Canada, Europe and other regions regarding electrical safety, hazardous materials restrictions, and electromagnetic compatibility. Evaluation methods are outlined for assessing products for safety hazards, electromagnetic emissions and immunity to interference. The basics of EMC design are also mentioned.
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NewBase 20 June 2024 Energy News issue - 1731 by Khaled Al Awadi_compressed.pdfKhaled Al Awadi
Greetings,
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NewBase 20 June 2024 Energy News issue - 1731 by Khaled Al Awadi
Regards.
Founder & S.Editor - NewBase Energy
Khaled M Al Awadi, Energy Consultant
MS & BS Mechanical Engineering (HON), USAGreetings,
Hawk Energy is pleased to present you with the latest energy news
NewBase 20 June 2024 Energy News issue - 1731 by Khaled Al Awadi
Regards.
Founder & S.Editor - NewBase Energy
Khaled M Al Awadi, Energy Consultant
MS & BS Mechanical Engineering (HON), USAGreetings,
Hawk Energy is pleased to present you with the latest energy news
NewBase 20 June 2024 Energy News issue - 1731 by Khaled Al Awadi
Regards.
Founder & S.Editor - NewBase Energy
Khaled M Al Awadi, Energy Consultant
MS & BS Mechanical Engineering (HON), USAGreetings,
Hawk Energy is pleased to present you with the latest energy news
NewBase 20 June 2024 Energy News issue - 1731 by Khaled Al Awadi
Regards.
Founder & S.Editor - NewBase Energy
Khaled M Al Awadi, Energy Consultant
MS & BS Mechanical Engineering (HON), USAGreetings,
Hawk Energy is pleased to present you with the latest energy news
NewBase 20 June 2024 Energy News issue - 1731 by Khaled Al Awadi
Regards.
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Hawk Energy is pleased to present you with the latest energy news
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MS & BS Mechanical Engineering (HON), USA
Adani Group's Active Interest In Increasing Its Presence in the Cement Manufa...Adani case
Time and again, the business group has taken up new business ventures, each of which has allowed it to expand its horizons further and reach new heights. Even amidst the Adani CBI Investigation, the firm has always focused on improving its cement business.
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L'indice de performance des ports à conteneurs de l'année 2023SPATPortToamasina
Une évaluation comparable de la performance basée sur le temps d'escale des navires
L'objectif de l'ICPP est d'identifier les domaines d'amélioration qui peuvent en fin de compte bénéficier à toutes les parties concernées, des compagnies maritimes aux gouvernements nationaux en passant par les consommateurs. Il est conçu pour servir de point de référence aux principaux acteurs de l'économie mondiale, notamment les autorités et les opérateurs portuaires, les gouvernements nationaux, les organisations supranationales, les agences de développement, les divers intérêts maritimes et d'autres acteurs publics et privés du commerce, de la logistique et des services de la chaîne d'approvisionnement.
Le développement de l'ICPP repose sur le temps total passé par les porte-conteneurs dans les ports, de la manière expliquée dans les sections suivantes du rapport, et comme dans les itérations précédentes de l'ICPP. Cette quatrième itération utilise des données pour l'année civile complète 2023. Elle poursuit le changement introduit l'année dernière en n'incluant que les ports qui ont eu un minimum de 24 escales valides au cours de la période de 12 mois de l'étude. Le nombre de ports inclus dans l'ICPP 2023 est de 405.
Comme dans les éditions précédentes de l'ICPP, la production du classement fait appel à deux approches méthodologiques différentes : une approche administrative, ou technique, une méthodologie pragmatique reflétant les connaissances et le jugement des experts ; et une approche statistique, utilisant l'analyse factorielle (AF), ou plus précisément la factorisation matricielle. L'utilisation de ces deux approches vise à garantir que le classement des performances des ports à conteneurs reflète le plus fidèlement possible les performances réelles des ports, tout en étant statistiquement robuste.
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Unlocking WhatsApp Marketing with HubSpot: Integrating Messaging into Your Ma...Niswey
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Unlock the full potential of the MECE (Mutually Exclusive, Collectively Exhaustive) Principle with this comprehensive PowerPoint deck. Designed to enhance your analytical skills and strategic decision-making, this presentation guides you through the fundamental concepts, advanced techniques, and practical applications of the MECE framework, ensuring you can apply it effectively in various business contexts.
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Enabling Digital Sustainability by Jutta EcksteinJutta Eckstein
This is a New Zealand wide meetup event with meetup groups from Auckland, Wellington and Christchurch attending and open to anyone with an interest in digital sustainability or agile. All welcome. Joke, this is how it started. Jutta is now also available in Germany, i.e. hosted by Berlin/Brandenburg
According to the World Economic Forum, digital technologies can help reduce global carbon emissions by up to 15%. However, digitalization also comes with some challenges. Thus, if we want to make a positive impact by increasing sustainability, we need to address challenges like the digital divide, energy consumption of IT, or the rise of electronic waste. In this talk, I want to explore how Agile can help to leverage Digital Sustainability.
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2. Outline
1 China Compulsory Certification (CCC)
requirement for Medical Devices
2 Defining Medical Devices
3 Main Contents of the Implementation
Rules for CCC for Medical Devices
4 Standards and Differences for Products
Compulsory Certification
5 Principles of Defining Application Units
6 Working Procedures for Application and
Certification
7 Application for Certification Mark
8 Interpretation on related issues
3. China Compulsory Certification
System for Medical Devices
1) Based on
Regulations of the People’s Republic of
China on Certification and Accreditation
4. China Compulsory Certification
System for Medical Devices
2) Categories:7
1. Medical X-ray Diagnostic Equipment
2. Hemodialysis Equipment
3. Extra corporeal Blood Circuit for Blood
Purification Equipment
4. Hollow Fiber Dialyzers
5. Implantable Cardiac Pacemakers
6. Electrocardiographs
7. Artificial Heart-Lung Machine
5. China Compulsory Certification
System for Medical Devices
3) Enforcement Date
1. Date of formal implementation (beginning to
accept): May 1, 2002.
2. Date of supervision and administration:
August 1, 2003.
Since August 1, 2003, the subject products
must obtain CCC certificates and be applied
CCC marks before imported.
7. China Compulsory Certification
System for Medical Devices
5) Accessibility of CCC documentation
Catalogue, Implementation Rules and
other relevant regulations are public and
transparent.
www.cnca.gov.cn
8. Defining Medical Devices
1. Medical X-ray Equipment
refers to medical devices which use X-ray imaging
for clinical diagnosis or realize operation or
treatment with the aid of X-ray imaging.
It means that medical X-ray imaging equipment is
subject to CCC.
9. 1. Medical X-ray Equipment
includes:
Radiographic X-ray system, Fluoroscopic X-ray system,
Gastrointestinal X-ray system, Mammography X-ray
system, Dental X-ray system, Surgical Imaging X-ray
system, Intervention Treatment X-ray system,
Angiographic X-ray system, X-ray Bone Densitometer,
X-ray Equipment for Computed tomography and other
equipment used the principle of X-ray imaging.
10. 1.Medical X-ray Equipment
The X-ray equipment used the X-ray
biological effect for radiation therapy is not
included in the scope of certification.
11. 2. Hemodialysis Equipment
The hemodialysis equipment is used for
hemodialysis treatment of patients
suffering renal failure.
12. 2. Hemodialysis Equipment
It includes: Hemodialysis Equipment,
Extracorporeal Blood Circuit for Blood
Hemodialysis Equipment, Hollow Fiber Dialyzer.
It does not include the Hemodialysis Equipment
used for treatment of patients suffering liver
failure.
13. 3.Artificial Heart-Lung Machine:
The artificial heart-lung machine is used during
open heart surgery, instead of the living heart-
lung in extra corporeal blood circulation.
14. 3.Artificial Heart-Lung Machine:
The artificial heart-lung machine consisting of
six parts are included in the scope:
1. Artificial Heart-Lung Machine Roller Pump
2. Artificial Heart-Lung Machine Pulsatile Roller Pump
3. Artificial Heart-Lung Machine Bubble Oxygenator (not
including membranous oxygenator)
4. Artificial Heart-Lung Machine Silicon Rubber Pump Tube
5. Artificial Heart-Lung Machine Water Heating/Cooling
System
6. Artificial Heart-Lung Machine Heat Exchanger
15. 4. Implantable Cardiac Pacemakers
The scope includes all implantable cardiac pacemakers,
but not include pacemaker powered by isotope cells.
5. Electrocardiographs
The scope includes detachable electrocardiographs for
diagnostic purposes, vector-cardiographs and equipment
for stress testing.
It does not include cardiac sounds graphs and equipment
monitoring heart.
16. Main Contents of the Implementation
Rules for Compulsory Certification
1. Scope of the products
2. Certification model
3. General requirements for certification including:
a) Principles of defining application unit for certification
b) Type testing and relevant test standards
c) Test samples, safety parts/components and relevant
requirements of testing
d) The requirements for inspection of factory,evaluation of
certification results and approval of certification
e) Follow-up inspection after issuing certificate
17. Main Contents of the Implementation
Rules for Compulsory Certification
4.Maintenance of the certificates and change for
covering product of certificate
5.Use of compulsory certification mark and
management of certificates
18. Certification Model of Compulsory
Certification of Medical Devices
The Certification model of medical Devices is
similar to the international fifth certification
model.
Type testing + Initial inspection of the factory +
Follow-up inspection.
19. Standards and Differences for Products
Compulsory Certification
1. The standards of compulsory certification for
medical X-ray diagnostic equipment are all in
accordance with the China national safety
standards transformed identically from the
IEC electrical safety standards, which issued
as the national compulsory safety standards. It
includes:
20. GB9706.1-1995 Medical electrical equipment
Part 1: General requirements for safety
(IEC 60601-1:1988 Medical electrical equipment- Part
1:General requirements for safety and amendment 1)
GB9706.3-2000 Medical electrical equipment
Part 2: Particular requirements for the safety of high-
voltage generators of diagnostic X-ray generators
(IEC 60601-2-7:1998 Medical electrical equipment-
Part 2:Particular requirements for the safety of high-
voltage generators of diagnostic X-ray generators)
21. GB9706.11-1997 Medical electrical equipment
Part 2: Particular requirements for the safety of X-ray
source assemblies and X-ray tube assemblies for
medical diagnosis
(IEC 60601-2-28:1993 Medical electrical equipment- Part
2:Particalar requirements for the safety of X-ray source
assemblies and X-ray tube assemblies for medical diagnosis)
GB9706.12-1997 Medical electrical equipment
Part 1: General requirements for safety
3. Collateral standard: General requirements for radiation
protection in diagnostic X-ray equipment
(IEC 60601-1-3:1988 Medical electrical equipment-Part
1:General requirement for safety 3. Collateral standard:
General requirements for radiation protection in diagnostic)
22. GB9706.14-1997 Medical electrical equipment
Part 2: Particular requirements for the safety of
associated equipment of X-ray equipment
(IEC 60601-2-32:1994 Medical electrical equipment-Part 2:
Particular requirements for the safety of associated
equipment of X-ray equipment)
GB9706.15-1999 Medical electrical equipment
Part 1: General requirements for safety
1. Collateral standard: safety requirements for medical
electrical systems
(IEC 60601-1-1:1995 Medical electrical equipment-Part 1:
General requirements for safety 1. Collateral standard Safety
requirements for medical systems)
23. GB9706.18-2000 Medical electrical equipment
Part 2: Particular requirements for the safety of X-ray equipment
for computed tomography
(IEC 60601-2-44:1999 Medical electrical equipment-Part 2:
Particular requirements for the safety of X-ray equipment for
computed tomography )
24. The differences between standards for certification
and international IEC standards
The standard of GB9706.1-1995 includes the amendment 1
(1991-11), and not cover the amendment 2 (1995-3 ).
The standard of GB9706.18-2000 was transformed according
to the IEC standard of IEC60601-2-44-1999. At present, the
GB standard is preparing to be transformed according to the
2.1 edition (2002-11) of the IEC standard.
25. 2. The standards for certification of
hemodialysis equipment
Hemodialysis Equipment is according to the standard:
GB9706.2-1991, which is identical with IEC601-2-
16:1989.change to GB9706.2-2003/IEC60601-2-16:1998
Extracorporeal Blood Circuit for Blood Purification
Equipment is according to the standard: YY0267-1995
Hollow Fiber Dialyzer is according to the standard:
YY0053-1991
26. 3. The standards for certification of Artificial
Heart-Lung Machine consisting of six parts
are as follows:
GB12260-90 for Artificial Heart-Lung
Machine-Roller Pump
GBYY0126-93 for Artificial Heart-Lung Machine-Pulsatile Roller
Pump
GB12261-90 for Artificial Heart-Lung Machine-Bubble Oxygenator
YY91048-99 for Artificial Heart-Lung
Machine-Silicon Rubber Pump Tube
YY91047-99 for Artificial Heart-Lung
Machine-Water Heating/Cooling System
GB12262-90 for Artificial Heart-Lung
Machine-Heat Exchanger
27. 4. The standard for certification of
Implantable Cardiac Pacemakers is
GB16174.1-1996.
It is identical with the standard of ISO 5841-
1989 Cardiac pacemaker-Part 1: Implantable
pacemaker
28. 5. The standard for certification of
Electrocardiographs is GB10793-2000.
It is identical with the standard of IEC60601-2-25:
1993 Medical electrical equipment- Part 2: Particular
requirements
for the safety of electrocardiographs
(IEC 60601-2-25:1993 Medical electrical equipment-
Part 2:Particular requirements for the safety of
electrocardiographs)
29. Principle of Defining Application Units
In principle, one type/model sample should be defined as
one application unit. The products, of same manufacturer,
but from different manufacturing premises, shall be in
different application units.
1. for the active medical electrical equipment, such as the
medical X-ray equipment etc. of which are the same or
similar of safety structure, main parts( assemblies ), and
safety critical components as the same series products
may be defined as one application unit.
30. Principle of Defining Application Units
2.for the passive medical electrical equipment,
such as Hollow fiber dialyzer etc., if the
materials and the processing of the products
are the same as well as the similar structure,
may be defined as one application unit.
31. The type testing shall be carried out on
the typical product to be selected in the
same application unit; for the product
with partial differences, of which only
need the testing.
32. Designated Certification Bodies
and Designated Laboratories
China Quality Certification Center (CQC)
Tel: +86 10 65994215
Address:
No.A10, Chaowai Dajie,
Beijing(100020) P.R.China
Http://www.cqc.com.cn
33. 4 laboratories authorized by CNCA
undertaking the testing work of medical
electrical equipment for certification
according to different categories of products.
34. Designated Certification Bodies
and Designated Laboratories
Liaoning Quality Supervision and Test
Institute for Medical Devices
medical X-ray diagnostic equipment
Shanghai Testing and Inspection Institute
for Medical Devices
electrocardiographs and implantable cardiac
pacemakers
35. Designated Certification Bodies
and Designated Laboratories
Guangzhou Testing and Inspection Institute for
Medical Devices
artificial heart-lung machine and
hemodialysis equipment
Beijing Testing and Inspection Institute for
Medical Devices
electrocardiographs, hemodialysis equipment
(not including extra corporeal blood
circuit for blood purification equipment
and hollow fiber dialyzer).
36. Working Procedures for
Application and Certification
Flow Chart on Application for CCC Certification
Application for certification
Acceptance of application
Testing of samples
Inspection of factory
Evaluation of certification
Issuing of certificates
37. 1. To make an application
The application can be made through the network/on
line.
The network address of CQC: www.cqc.com.cn
The application information and application form in
English edition can be available from the network
page.
38. 2. The applicant should send the relevant
documents to the Department 4 of CQC after
submitting the application. It should at least
includes:
39. Instructions for use, technical description and
service manual.
Product assembly chart, working (electrical)
principle diagram, circuit diagram and parts
diagram.
Product instructions for installation and
adjustment.
Product inspection/testing report (including basis
and method of testing).
40. List of the critical parts for the safety (including
mane, model, specifications, manufacturer,
executive standard and the case of safety
certification).
The applicant shall submit simultaneously the
description of product and of the differences among
types/models of the same application unit.
41. 3. Preparation and testing of samples
In principle, the samples should be sent to the appointive
laboratory for carrying out type testing.
The standards basis for testing samples shall be the
relevant standards listed in the implementation rules for
certification.
for the special case, applicant can make an application for
testing on site;
42. 4. Preparation and implementation on
inspection of factory
Factory quality assurance capability
Consistency of products (name plate, structure,
critical parts)
Witness test, if necessary
Timing of inspection
43. Application for Certification Mark
Issuing and Managing Center for CCC Mark
Tel: 0086-10-65994033
Fax: 0086-10-65994060
www.cnca.gov.cn
44. Interpretation on related issues
Follow up inspection
Procedure for change
Re-assessment on Medical Device
Testing on site
Medical product Standard status
45. Follow up inspection
Content of follow up inspection: assessment
of quality assurance capability, inspection on
consistency of products, and submission of
sampled specimens to test laboratories for
tests, if necessary.
The follow-up inspection shall normally be
implemented at least once per year.
46. Procedure for change
Standard revise on medical device
Implementation rules for CCC medical
device revise
Change of information list on CCC
Certificate
Change on critical component and martial of
the product
Change of design of the product on safety
47. Re-assessment on Medical Device
Samples testing
The testing of supplying samples shall be
compliance with the application unit
Factory quality assurance re-assessment
Timing of re-assessment
after getting the certificate for the fifth year
48. Testing on site
The sample shall be installed on site or test
expeditiously because of hard
After the approval of certification body
satisfy the relevant conditions and possess
facilities for testing samples.
49. Medical product Standard status
GB9706.23-2005 /IEC60601-2-45:2001
Medical electrical equipment-part 2-25
particular requirements for the safety of
mammographic X-ray equipment and mammographic
sterotactic devices
GB9706.23-2005/IEC60601-2-43:2000
Medical electrical equipment-part 2-43
particular requirements for the safety of X-ray
equipment for interventional procedures