1. Scope of Application:
This procedure applies to public health emergencies that need processing, and there is no similar product listed in China. Or although similar products have been listed in China already, however the product supply cannot meet the needs of emergency handling of public health emergencies and has been confirmed by NMPA for the approval of domestic class III and imported class II and class III medical devices. Products that are urgently used in accordance with the Regulations on the Supervision and Administration of Medical Devices do not apply for this procedure.
(1) The applicant submits the "Application Form for Emergency Approval of Medical Devices" and the product research summary data and relevant instructions to the acceptance department of NMPA.
(2) NMPA will evaluate and confirm whether the product is subject to emergency approval.
(3) Conduct test for medical device of emergency approval.
(4) CMDE shall designate special personnel to intervene early and conduct pre-acceptance pre-review.
(5) The corresponding medical products administration of provinces, autonomous regions and municipalities directly under the Central Government shall organize and conduct quality management system inspections.
(6) The registration applicant shall select "emergency approval" in the application form, and CMDE will conduct a file review.
(7) Review time limit for Import Class II/III: After the registration application is accepted and the payment is confirmed to be transferred to the technical review stage, NMPA shall complete the technical review within 5/10 days; after the technical review is completed, the administrative review and approval shall be completed within 3 days.
(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 registration requirements and obtain the registration application acceptance, the emergency approval will no longer be handled.
Emergency review and approval procedures for medical devices-No.157 in 2021