Medical Device Emergency Approval Procedures

Emergency approval procedure is to ensure that the response to the needs of the emergency public **** health incidents, within the time limit for the rapid completion of medical device registration and approval of related work.... Innovative medical device special approval process is for the core technology invention patents, international leading, domestic first, with significant clinical application value of medical devices, take in accordance with the early intervention, specialists responsible for strengthening communication, the principle of priority to be supported.

I. Medical Device Emergency Approval Process:

1. Submit the application synthesis information to the National Bureau

2. The National Bureau determines whether to agree to accept, defines the product management category, and notifies the applicant of the result.

3, the organization of medical device registration inspection.

4, out of the assessment report, for administrative approval.

Two, the medical device classification directory:

1, device class: 6801, 6802, 6803, 6804, 6805, 6806, 6807, 6808, 6809, 6810, 6812, 6813, 6816, 6820, 6827;

2, equipment, appliances: 6821 (Class II) 6822 (Class II) 6823, 6824, 6825, 6826, 6831, 6834, 6840, 6841, 6845, 6854, 6855, 6856, 6857, 6858;

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

4, implantation, intervention and artificial organs: 6821 (Class III), 6822 (Class III) 6846, 6877;

5, medical materials: 6863, 6864, 6865.

Legal basis: "supervision and management of medical devices regulations" Article 6 Drug supervision and management departments set up or designated by law, medical device review, inspection, testing, monitoring and evaluation of professional and technical institutions. , monitoring and evaluation and other professional and technical institutions, in accordance with the division of responsibilities to undertake the relevant technical work, for the supervision and management of medical device production and provide technical support.