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CFDA: The CFDA Issues an Announcement regarding the Filing of Records for Clinical Trials of Medical Products and Devices

7. August 2015

Certain medical products and devices are required to have registration of medical devices approval by the China Food and Drug Administration (CFDA, 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. There have been many changes and revisions within the Chinese regulatory framework of the CFDA regulations in an effort to ensure the safety and effectiveness of medical products for the Chinese market.

The CFDA issued an announcement regarding the filing of records for clinical trials of medical products and devices. The goal is to standardize the record filing of clinical trials and to improve the supervision and management of medical device clinical trials.
Portrait of two surgeons wearing surgical masks in the operating

The CFDA recently issued the Measures for Unannounced Inspection of Drugs and Medical Devices, which will take effect on September 1, 2015. The measures provide that development, production, operation and the processing of drugs and medical devices are included in the scope of unannounced inspections. The goal of these inspections is to make sure that that manufacturers stay up to date with the current regulations and to support the positive development of China’s medical equipment industry, guaranteeing the quality and safety of medical products. It is expected that there will be more announcements, reforms and updates to the CFDA regulations in future.

In our News section on our website, we will keep you informed regarding the official announcements and changes to these regulations.

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