The NMPA issued the “Notice regarding implementation of Medical Device Registration and Filing Management Measures and In Vitro Diagnostic Reagents Registration and Filing Management Measures” which have been effective since October 1, 2021.
The new registration measures have impacts in new submissions in its format and content requirement particularly now it requires GMP related documents. In addition, clinical evaluation content and format need to be updated as a result of the new series of clinical evaluation related guidelines. E-filing (Electronic Regulated Product Submission, eRPS) flow also needs to be reorganized. To avoid rework, try to have your new registration accepted before the end of 2021.
The new medical device & IVD registration and filing measures was introduced in support of the China State Law, Order 739 with significant changes in the complete product life cycle such as expediting innovation, streamlining premarket submission, and post market penalty. State Order 739 “Regulation on the Supervision and Administration of Medical Devices” was introduced on March 16, 2021.
Medical Device IVD Registration
The NMPA explains the following to better implement the measures:
For applications accepted before January 2021
For registration applications accepted before January 2021 and have not been approved, the NMPA will continue to review and approve based on the original regulations.
About the inspection report involved in the supplementary materials
For registration applications accepted before 1, 2021 and have not been approved, if the supplementary materials involve inspection reports, the registration applicant shall entrust a qualified medical device inspection agency to issue a supplementary inspection report; if the applicant has inspection capabilities, self-inspection report can be submitted.
For applications accepted before the implementation of the new mandatory standards
For the applications accepted before the implementation of the new mandatory standards, unless the NMPA has otherwise mentioned, the applications can still be reviewed based on the previous standards.
About the biological test
If biological tests are involved in the biological evaluation of medical devices, the biological test reports shall be submitted by the applicant as research materials. To carry out biological tests, a medical device inspection institution with biological test qualification shall be entrusted to conduct tests in accordance with relevant standards. The biological test report issued by a foreign laboratory should be accompanied by a quality assurance document that the foreign laboratory shows that it meets the requirements of the GLP laboratory.
For Class I medical devices
No clinical evaluation data is required for the filing of Class I medical devices.