Two Provisions for Medical Device Registration and Filing Issued in One Day!
On August 31, 2021, China issued the Provisions for Medical Device Registration and Filing and the Provisions for In-vitro Diagnostic Reagent Registration and Filing, which shall come into force as of October 1, 2021
Background
As Order #739 (the new Medical Device Regulations) was recently has become effective on June 1, 2021, the two new Provisions are released to further implement the reform changes on the medical device supervision, management and registration. The new Provisions follows the legislative structure of former Provisions for Medical Device Registration and Filing and the Provisions for In-vitro Diagnostic Reagent Registration and Filing.
Major Contents
The key contents of the revision are as follows:
1.Strengthen the responsibilities of regulatory authorities and intensify supervision to registration applicants.
- Improve the relevant provisions for risk control of clinical trials and on-site inspection of clinical trials.
- Strengthen responsibilities of medical device registration applicants, requiring them to improve the quality management over the whole life cycle of medical devices and bear responsibilities for the safety, effectiveness and quality controllability of medical devices.
QMS/PMS is much more important for the manufacturers. Detailed interpretation of this part can be find in our upcoming webinar to be launched on September 2, 2021, 7:00-8:00 AM Pacific Time:
2.Simplify the requirements for registration/filling dossiers including overseas marketing certificate and test report.
- For the innovative medical devices not marketed overseas, there is no need to submit the overseas marketing certificate, which aims to encourage the innovative products to be marketed in China as soon as possible.
- Adjust the requirements for test report of Class II and Class III medical devices and specify that registration applicants may submit self-test report.
3.Optimize the review and approval procedure.
- Specify the circumstances under which the clinical evaluation data are exempted to be submitted and the requirements for the implied licensing of clinical trials.
- Improve the work efficiency of medical device registration and filing.
