The NMPA “Medical Device Registration and Filing Management Measures” and “In Vitro Diagnostic Reagents Registration and Filing Management Measures” 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 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 NMPA released a Q&A to address issues manufacturers are often concern of:
On Class II Device Registration
What changes will be made to the registration materials’ requirements for Class II devices?
From January 1, 2022, the application materials for Class II device registration shall comply with the “Application Materials Format and Approval Document Format for Medical Device Registration” and the “Application Materials Format and Approval Document Format for In Vitro Diagnostic Reagent Registration”
If a new mandatory medical device standard or national standard product is released within the validity period of the device registration certificate, is it necessary to apply for a change of registration (modification)?
There will be two circumstances:
If the changes made to the products are subject to a change of registration (modification), the registrant should submit an application for modification.
If the changes made to the products are not subject to a modification, the registrant shall provide a description of the situation and relevant certification materials.
On Inspection of Quality Management System (QMS)
How to carry out the inspection of QMS for the registration of Class III medical devices?
From January 1, 2022, the inspection of the quality management system for the registration of Class III medical devices will continue to follow the “Work Procedures for the Inspection of the Quality Management System for the Registration of Class III Medical Devices in China (Interim)”. After the NMPA revises and issues new verification procedures, it will be implemented in accordance with the new regulations.
How to carry out inspection for Class II device if the registration application is accepted before the implementation of the Measures?
If the application acceptance number of Class II medical device is 2021, they can submit the QMS inspection data according to the prior regulations; if the registration application acceptance number is 2022, the inspection data will not be submitted separately.
The Q&A also provides guidance on self-testing and market authorization holder system. For more information, please email us at info@ChinaMedDevice.com.