An amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted by the China State Council on December 22, 2020. On March 16, 2021 the amendment was signed into law, Decree 739, with the effective date of June 1, 2021.
After the draft version issued on June 25, 2018 (For RAPS interview with Grace Palma, CEO of China Med Device, on the draft please click HERE), the NMPA took almost three years to finalize it.
The 41-page document includes the following sections:
- General Principle
- Registration & Filling
- Supply and Usage
- Adverse Event Handling and Device Recall
- Supervision and Inspection
The Decree regulates every aspect in the medical device industry in China. It is:
- to establish the Market Authorization Holder (MAH) system, specify the responsibility of enterprises, and vitalize the market
- to implement reform measures, simplify and optimize review and approval procedures, improve clinical evaluation and clinical trial management, and encourage the innovation
- to further enrich the supervision means, improve the supervision system, and improve the supervision efficiency
- to increase the penalties for illegal acts, implement punishment measures to increase the cost of violations, and drive serious offenders out of the market
We will do an in-depth analysis on the Decree, please sign up our latest NMPA news HERE.