ISSUING AUTHORITY:

National Medical Products Administration

DATE OF ISSUANCE:

December 29, 2021

EFFECTIVE DATE:

December 29, 2021

On December 29, 2021, the National Medical Products Administration (NMPA) announced the Procedures for Emergency Approval of Medical Devices (the “Procedures”), which took effect on December 29, 2021.

The Procedures clarify that provincial drug administrations may, when necessary, take the way of early intervention to evaluate the products to be declared and timely guide the applicant for registration to carry out the relevant declaration work. The NMPA shall organize experts to timely confirm whether the products are subject to emergency approval and notify the results to the applicant, the corresponding technical agency, and the drug administration of the province, autonomous region or municipality directly under the Central Government. With regard to registration inspection, the NMPA may designate an inspection institution with inspection capability to carry out the inspection. In terms of technical review, the materials submitted by enterprises for registration will be pre-reviewed according to the principle of “review upon receipt”.

It is worth noting that, in the previous version of the Procedures, products subject to emergency approval were only “medical devices under the application for emergency approval”. The newly revised Procedures add “medical devices required by emergency response and recommended by the national working mechanism of emergency response”. The NMPA organizes experts to timely confirm whether a product is subject to emergency examination and approval, which provides strong support for the emergency examination and approval of national emergency products.

In addition, the Procedures add new requirements on the time limit for emergency approval and the exit mechanism. With respect to the time limit for emergency approval for a medical device subject to emergency approval that is approved for marketing with conditions, the Procedures require that the validity period of the medical device registration certificate shall be consistent with the time limit for completion of the conditions indicated on the registration certificate and shall not exceed 1 year in principle. If the registrant has satisfied the conditions, it may apply for renewal of registration before the expiry date. If the requirements are met, the renewal shall be granted, and the validity period of the registration certificate shall be 5 years.

Meanwhile, the Procedures propose an exit mechanism for medical devices subject to emergency approval, stating that if an applicant for registration fails to complete the preparation of the application documents and has the registration application accepted under the registration requirements within 90 days after the emergency approval is confirmed, the application shall no longer be subject to emergency approval. In principle, the Procedures for Priority Approval of Medical Devices may be referred to for priority review and approval upon acceptance.

Reference:

国家药监局关于发布《医疗器械应急审批程序》的公告（2021年第157号）