On December 29th, 2021, the National Medical Products Administration (NMPA) in China published new emergency approval procedures for medical devices under Procedure No. 157. This procedure applies in public health emergencies and is designed for cases where no similar product is listed in China. The intent is to address situations where the product supply does not meet the demands of emergency handling and has been verified by the NMPA for the urgent use of domestic class III and imported class II and class III medical devices.

Steps for Application

The steps for the application of the procedure are:

1. The applicant submits the "Application Form for Emergency Approval of Medical Devices" along with product research summary data and relevant instructions to the acceptance department of the NMPA.
2. NMPA will evaluate and confirm whether the product qualifies for emergency approval.
3. Conduct tests for the medical device seeking emergency approval.
4. The China National Medical Device Evaluation Center (CMDE) will designate special personnel to intervene early and conduct pre-acceptance pre-review.
5. The relevant medical provinces, autonomous regions, and municipalities will organize and conduct quality management system inspections.
6. The registration applicant must select "emergency approval" in the application form, after which the CMDE will conduct a file review.
7. Review time limit for Import Class II/III: After acceptance of the registration application and confirmation of payment, NMPA shall complete the technical review in a timely manner.
8. Within 90 days from the date of confirmation of emergency approval, if the registration applicant cannot complete the preparation of registration application materials according to the requirements, the emergency approval will no longer be processed.