July 13, 2018

In order to optimize the evaluation system of medical device and encourage the innovation of medical equipment, the Ministry of Justice of China has drafted some changes on Regulation on the Supervision and Administration of Medical Devices. This draft is open for public comments until July 24.

The revised regulation covers the following topics:

  • "Enhancement of system for license holders",
  • "Reform of Clinical Trial Management System",
  • "Optimization of Reviewing and Approval procedures",
  • "Improvement of requirements for post-market supervision".           

Qualtech outlines the following key points from the drafted guidance:           

1. The approval of the Class II domestic products shall be changed by the CNDA, and not by the local government.           

2. Additional obligations of license holders of medical devices.           

3. Additional obligations of local authorities in charge of foreign medical devices.           

4. Adjustments in the requirements for the preparation of a clinical evaluation document.           

5. Added permissions for license holders to establish their own manufacturing site or to entrust a contractor company to produce the products.           

6. Medical devices shall have unique device identification.           

7. Publishing of relevant regulations on the registration of medical devices which are urgently needed in clinical trial.           

8. Manufacturer may submit the test report by themselves, or by the certified test institution to the CNDA for registration.

9. Strengthen post-market supervision;           

10. Increase fines for illegal acts.   



1. The amendments to the regulations on the supervision and administration of medical devices (Draft)           

2. Explanation on the amendment to the regulations on the supervision and administration of medical devices (Draft)