Hamburg, 01.10.2021, Yannan Xu

As a supplement to the State Council Decree No.739 and NMPA Order No.47 in China, NMPA released today the new medical device registration dossier requirements and the format of the certification of approval. It will be effective from January 1, 2022. The previous CFDA Notice No. 43 of 2014 is then repealed.

https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210930155134148.html

Attachments included in the announcement

  1. People’s Republic of China medical device registration certificate (format)
  2. People’s Republic of China medical device change registration (filing) documents (format)
  3. NMPA medical device clinical trial approval opinion sheet (format)
  4. Medical device format requirements of the registration dossier and certification of approval
  5. Medical device registration dossier requirements and instructions
  6. Medical device renewal registration dossier requirements and instructions
  7. Medical device change filing / change registration dossier requirements and instructions
  8. Medical device clinical trial registration documents requirements and instructions
  9. List of basic principles of medical device safety and performance