Since May 1st,  the new version of <the measures for the supervision and administration of medical device production >and <the measures for the supervision and administration of medical device operation> have been officially implemented.

The state pointed out that the two measures will be strictly implemented as the “four strictest” requirements.


Firstly, < the regulations on the supervision and administration of medical devices> should be implanted, the system of medical device registrants and recorders should be fully implemented. The administrative licensing process should be optimized, the supervision and inspection measures should be strengthened, the supervision and inspection means should be improved, the main responsibility of enterprises should be strengthened, and the punishment of illegal acts should be further strengthened.

Secondly, the management requirements for sales, transportation, storage and other aspects of business links should be improved, the relevant provisions on traceability management such as purchase inspection and sales records should be refined, and the quality and safety responsibility of registrants and filers for selling their registered and filed medical devices should be strengthened.

Thirdly, the production report system of medical devices should be established, specifying the requirements of product variety report, production dynamic report, production condition change report and annual self inspection report on the operation of quality management system.

Fourthly, supervision responsibility should be taken by related departments. The responsibilities of regulatory departments at all levels should be refined and improved, and various forms of supervision and inspection should be improved, such as supervision and inspection, key inspection, follow-up inspection, causal inspection and special inspection.

Some changes in management regulation

1. Principles and requirements of classified management:

The operation of class I medical devices does not require permission and filing. The operation of class II medical devices shall be subject to filing management. The operation filing of class II medical devices whose product safety and effectiveness are not affected by the circulation process may be exempted, and the operation of class III medical devices shall be subject to licensing management.

2. Regulatory principles and requirements:

Through the comprehensive use of random inspection, flight inspection, responsibility interview, safety warning, credit file and other systems, enrich regulatory measures, improve regulatory means and promote the implementation of regulatory responsibilities.

3. Requirements of traceability principle:

It is stipulated that the enterprise shall establish and implement the purchase inspection record system. Enterprises engaged in the wholesale business of class II and class III medical devices and the retail business of class III medical devices shall establish a sales record system.

Post time: May-16-2022