China’s State Council publishes a new Medical Device Regulation (Order no. 739) replacing Order no. 680 to follow conditional approvals on rare diseases treating medical devices.
Order no. 739 covers
- Balancing clinical needs and risks
- Encouraging innovation
- Emphasizing MAH’s compliance responsibilities
- Re-positioning local legal agents
The new regulation will be in effect from June 1, 2021 for conditional approval of medical devices in public health emergencies. Products already approved in other countries can be easily accessed in Chinese markets without Clinical Evaluation. The revised order also introduces personal liability on the legal representatives, main responsible persons, directly responsible supervisors, or other personnel of MAHs.
Clinical Aspect of the order
Expanded access to investigational devices will be made available for patients in the study sites upon ethics committee approval and the patients’ giving informed consent, provided that the investigational devices are used for critical, life-threatening diseases without an effective treatment method and can confer clinical benefits on patients based on medical judgment.
Distributors of certain Class 2 medical devices whose safety and effectiveness will not be affected by the distribution process can be exempted from filing a distribution record with local MPAs.
R&D focusing aspect
The order provides a good opportunity for medical device companies to review their market entries and growth strategies in China. R&D-focused companies with a product portfolio that demonstrates clinical values will be able to take advantage of the new pathways to accelerate their time to market. Moreover, it will be critical for foreign medical device companies to select Chinese partners who have the necessary capabilities and a strong compliance culture to act as local appointees. Finally, Order #739 calls for a careful examination of companies’ existing operations in China, as failure to address legacy issues can result in more serious consequences in the future.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.