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CFDA: CFDA Announces 90 Additional New Industry Standards for Medical Products

24. April 2015

Certain medical products and devices are required to have prior approval by the CFDA (China Food and Drug Administration Chinese: 国家食品药品监督管理总局) before they can be sold or used in China. In an effort to insure continued safety and effectiveness of medical products, there have been numerous changes and revisions within the Chinese regulatory framework for CFDA certification.

In March of 2014 the CFDA published a completely new version of the “Regulations for the Supervision and Administration of Medical Devices” (Chinese: 医疗器械 监督管理条例(修订草案).

Previously in our “News” section we informed you (“CFDA Announces 120 New Industry Standards for Medical Products”) that the CFDA introduced 120 new Industry Standards (abbreviated as “YY Standards”) in announcement No. 30 dated July 3, 2014.

On April 8, 2015 the CFDA has released announcement No. 8 which introduced another 90 new Industry Standards for medical products. The announcement includes 14 mandatory and 76 recommended industry standards. The issuance of these changes will further improve the medical device standards system of China and help improve the overall quality of medical devices.
Portrait of two surgeons wearing surgical masks in the operatingThe new standards apply to the following products:

  • Implants for surgery
  • Medical electrical equipment
  • In vitro diagnostic reagents
  • Dentistry

The purpose for these changes is to promote the positive development of China’s medical equipment industry and to ensure the quality and safety of medical products. It is expected that there will be more announcements, reforms and changes to the CFDA regulations in the future. In our “News” section on our website, we will keep you informed regarding official announcements and changes to the regulations.

Please do not hesitate to call or email with any questions you may have.


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