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CFDA: CFDA Issues Working Procedures for the Audit of Quality Management Systems for the Registration of Medical Devices

26. August 2015

Certain medical products and devices are required to have CFDA registration 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 imported, bought, sold, used or traded in China. In an effort to insure safety and effectiveness of medical products, there have been numerous changes and revisions within the Chinese regulatory framework of the CFDA registration.

Recently the CFDA issued Working Procedures for the Audit of Quality Management Systems for the registration of Medical Devices in the “Domestic Class III” sector. The Working Procedures stipulate the work linkage between the CFDA technical evaluation institutions and provincial regulatory departments. They also set the formal framework of the auditing system including the required audit documents, the audit timeline, the audit results, and the relation between audit results and product registration evaluation.

In an effort to control and increase the safety of medical devices in China, there have been many regulatory restructuring and revisions of the regulations in recent years. It is important that manufacturers stay up to date with the current regulations. Some of the more recent published updates are as follows:

• March 2014 – The CFDA published a completely new version of their “Regulations for the Supervision and Administration of Medical Devices” (Chinese: 医疗器械 监督管理条例(修订草案)
• July 2014 – The CFDA launched “120 new industry standards for medical devices” (abbreviated as “YY-Standard”).
• 2015 – The CFDA introduced another 90 industry standards (you can find more information on these in our news section).
medical healthcare testThe 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