Decree 739 Regulation on Supervision and Management of Medical Devices, announced on March 18, 2021, allows self-test report to replace the report submitted by authorized testing centers. It says that “testing report can be the self-test report of the medical device registration applicant or filing person, or the test report issued by a qualified medical device test agency”. In the Decree 680 issued in 2017, only Class I device can utilize self-test report.
Key Areas of the NMPA Self-Test Report
The NMPA asks manufacturers pay attention to the following aspects:
Applicants should incorporate the self-test work into the medical device quality management system. The regulations require applicants to have self-test capabilities in terms of personnel, equipment and environmental facilities, sample management, test quality control, and record control.
Requirements for inspectors
Applicants should conduct standardized management in terms of personnel recruitment, professional competence, training, job evaluation, authorization, etc. It is stipulated that inspectors can only work in the enterprise and be authorized to engage in test work.
Requirements for test laboratories
For biological evaluation, electromagnetic compatibility, biological safety, in vitro diagnostic reagents, etc., special environmental facility conditions should be set up.
Requirements for self-test of commissioned manufacturing
If the applicant authorizes a manufacturer to carry out its own self-test, the quality agreement of the two parties shall specify the requirements for the manufacturer’s test capabilities. If the authorized manufacture does not have the capability, the applicant shall entrust a qualified test agency to conduct the test.
Requirements for internal self-test of corporate group
An accredited CNAS laboratory can conduct self-test for the corporate group which the laboratory and the domestic applicant both belong to. The test report shall be issued by the applicant. Corresponding self-check report. The laboratory needs to be authorized by the group company, to avoid problems such as mutual entrustment between subsidiaries and unclear responsibilities.
Domestic or overseas group companies may have cross-border test laboratories. Domestic registration applicants can only conduct self-test by the domestic laboratories of their group company; overseas registration applicants can only be conducted by their group company overseas.
It also addresses the issues on qualification of the test agency and requirements for their NMPA self-test report, registration submission and on-site test.
For an English copy of the “Regulations on Self-test of Medical Device Registration”, please email info@ChinaMedDevice.com. We have testing engineers to help you with gap analysis and expedite your type testing needs and shorten your renewal or new approval time.