On January 2023, the CMDE issued Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries.
In order to urge medical device registrants and filers to implement the main responsibility for the quality and safety of medical devices, The China National Medical Products Administration (NMPA) and Center for Medical Device Evaluation (CMDE) published new rules for the supervision and management of enterprises implementing medical device safety, as well as draft guidelines for the registration and review of implantable medical device batteries.
Specification applies for:
- It will go into effect March 1, 2023
- Registrants and record filers must ensure the quality and safety of medical devices.
- The Interpretation of the Regulations on the Supervision and Management of Companies Implementing Primary Responsibility for the Quality and Safety of Medical Devices further discusses the provisions of the Regulations.
- The CMDE notice opening the public consultation of the draft Guidelines, which will standardize the technical review requirements and provide guidance for the application/registration of enterprises.
- Comments or suggestions must be sent via email before January 6, 2023.
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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.
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