Emergency approval procedures for medical devices

The emergency approval procedure is to ensure that the related work of medical device registration and approval can be completed quickly within the prescribed time limit to meet the needs of public health emergencies. Innovative medical device special examination and approval procedures are based on the principles of early intervention, special person in charge, strengthening communication, giving priority to the examination and approval of medical devices with core technology invention patents, leading in the world, pioneering in China, and significant clinical application value.

First, the medical device emergency approval process:

1. Submit application summary materials to the General Administration.

2, the National Bureau to determine whether to accept, define the product management category, and inform the applicant of the results.

3, the organization of medical device registration inspection.

4. Evaluation report and administrative examination and approval.

Second, the medical device classification directory:

1, instruments: 680 1, 6802, 6803, 6804, 6805, 6806, 6807, 6808, 6809, 68 10, 68 12.

2. Equipment and appliances: 682 1 (Class II), 6822 (Class II), 6823, 6824, 6825, 6826, 683 1, 6834, 6840, 684 1, 6884.

3. Large medical equipment: 6824, 6825, 6828, 6830, 6832, 6833;

4. Implants, interventions and artificial organs: 682 1 (Category III), 6822 (Category III), 6846 and 6877;

5. Medical materials: 6863,6864,6865.

Legal basis: Article 6 of the Regulations on the Supervision and Administration of Medical Devices. Professional technical institutions such as medical device review, inspection, testing, monitoring and evaluation established or designated by the pharmaceutical supervisory and administrative department according to law undertake relevant technical work in accordance with the division of responsibilities, and provide technical support for the supervision and management of medical device production.