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Category: China IVD RA

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

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

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

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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