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Category: Resources

Must-read: NMPA Pre-submission consultation of Registration process for medical devices

2019-10-172019-10-17 jmedtec0

The Chinese authority NMPA has made a carton illustration for a pre-submission consultation of registration process for medical devices.

China IVD RA, China Medical Device RA, Resources

NMPA Overseas Audit at Medtronic, Inc. in the USA (2019/03/05)

2019-09-192019-09-19 jmedtec0

License Holder: Medtronic, Inc. Address of License Holder: 710 Medtronic Parkway N.E. Minneapolis MN 55432 USA Manufacturing Site: 3800 Annapolis Lane Plymouth, MN 55447, USA. China Agent: Medtronic Shanghai Product: Artificial heart valve Type of Inspection: Regular Supervision Guidelines for…

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China Medical Device RA, Resources

China issues revised drug administration law on August 26th, 2019

2019-08-282019-08-29 jmedtec0

On August 26th, 2019, China’s top legislature voted to adopt the revision to the drug administration law, which is an update from the version in the year of 2001. In the updated drug law, the concept of marketing authorization holder…

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China News, China Pharma RA, News, Resources

List of Innovative Devices Approved to Enter Green Channel Registration (Continuously updated)

2019-08-092019-08-09 jmedtec0
China Medical Device RA, Resources

List of Prioritized Devices Approved to Enter Green Channel Registration (Continuously updated)

2019-08-092019-08-09 jmedtec0
China Medical Device RA, Resources

Overview of the Most Important IVD Regulations in China (Continually updated)

2019-03-272019-03-28 jmedtec0

This page gives a summary of the most important in-vitro diagnostic reagent regulations in China, so regulatory professionals who are in charge of global regulatory management and do not speak Chinese can easily follow changes of the regulations. The regulations…

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China IVD RA, Resources

Guidelines for Specific Medical Devices (Continually Updated)

2019-03-272019-03-27 jmedtec0

The NMPA (ex-CFDA) has also published lots of product-specific guidelines for technical review and clinical trials. JMedTec has summarized the complete list of all the guidelines as below. Please use the product keywords to search whether any guidelines are relevant…

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China Medical Device RA, Resources1 Comment on Guidelines for Specific Medical Devices (Continually Updated)

Overview of the Most Important Medical Device Regulations in China (Continually updated)

2019-03-262019-03-27 jmedtec0

This page gives a summary of the most important medical device regulations in China, so regulatory professionals who are in charge of global regulatory management and do not speak Chinese can easily follow changes of the regulations. The regulations are…

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China Medical Device RA, Resources

Complete List of Medical Device and IVD Standards in China and the International Equivalence (Continually Updated)

2019-03-212019-03-28 jmedtec0

China has its own standard system including National Standards (GB) and Medical Industry Standards (YY), which is often confusing for foreign professionals to follow as the standards are only available in Chinese. Therefore, JMedTec has created this page to show…

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China IVD RA, China Medical Device RA, Resources

ICH Guidelines adopted in China (Continually Updated)

2019-03-19 jmedtec0
China Pharma RA, Resources

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Recent Posts

  • China Ministry of Science and Technology gives full support to the development and approval of rapid assay of Novel Coronavirus (2019-nCoV)
  • Approval of medical devices and IVDs within two weeks during the coronavirus emergency
  • China allows overseas medical devices import without registration into the country due to the coronavirus emergency
  • Some hospitals in the Greater Bay Area in China may exempt from the China NMPA registration for use the drug and medical devices registered in Hong Kong SAR
  • Booming Healthcare Sector at the 2nd China International Import Expo (CIIE) held in Shanghai

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