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CFDA: Chinese Product Names Compulsory for Foreign Medical Devices

26. February 2016
Starting April 1, 2016, all foreign medical devices are currently registered or that will be registered with the CFDA in China will need a Chinese product name. This new requirement spelled out in paragraph 26 of the CFDA regulations for medical devices (announced in version 650 by the State Council of the PR China).

This new requirement is to ensure that users of medical devices have a better understanding of their functions. In its announcement the Chinese State Council stated similar requirements for naming medical devices in the USA, Europe, Japan and other countries.

In choosing Chinese product names several requirements need to be followed to be in compliance with the CFDA regulations. Some of the requirements include:

  • Choosing a product name that directly refers to the product’s use/function
  • If the device has different model versions and functions, there should be a common core word with not more than three additional words
  • Product names should not include registered trademarks, company names or symbols

Team of surgeons in the operating room, female surgeon holding s
You can find further information about our services for CFDA registration on our website.

It is expected that there will be more announcements, revisions and changes to the CFDA regulations in the near future. In our News section on our website, we will keep you informed regarding the official announcements.

Please do not hesitate to call (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673) or email and we will be happy to answer questions.


MPR Author

About the author: Julian Busch is founder and managing director of MPR China Certification GmbH
Publisher: MPR China Certification GmbH

Tel.: +49 69 271 37 69 150