Highest Decree of Medical Devices Revealed March 16, 2021

2021-03-25

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 , the NMPA took almost three years to finalize it.

The 41-page document includes the following sections:

General Principle
Registration & Filling
Manufacturing
Supply and Usage
Adverse Event Handling and Device Recall
Supervision and Inspection
Liabilities
Annex

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 follow up.

If you have any further questions about this amendment, please contact us at info@inspirativemed.com.