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State Food and Drug Administration: Medical devices are registered first and then produced

2019/04/29

State Food and Drug Administration: Medical devices are registered first and then produced

Pharmaceutical Industry (HC) On the morning of April 1, the State Food and Drug Administration and the State Council promulgated "regulations" for the supervision and management of medical devices. The newly revised "regulations" are based on the risk level. According to the degree of risk, to ensure product safety and effectiveness, pipes, combined with strict no, high-risk product production and operation enterprises "compress" and low-risk product production and operation enterprises "relax", promote medical device production and operation enterprises to be bigger and stronger.

The new "Regulations" amends the regulations on medical equipment, the original "production license, after product registration" is changed to "first product registration, production license is issued", providing medical product registration licenses for manufacturers, who can apply for medical devices Production License. Changes in the regulatory model, not only to further encourage business innovation, but also reduce the previous real estate investment in the enterprises to obtain registered products. In addition, new "regulations" reflect the need for further decentralization. The newly revised "Regulations" will be the first class of medical equipment production, from the original to the local provincial food and drug supervision department for the record, to the local municipal food and drug supervision department for the record. At the same time, the domestic first-class medical device registration changes are filed by the municipal food and drug supervision department, so as to realize the unified supervision and management agency filing of medical equipment products and production, and the supervision power and responsibility are more clearly defined.

The new "Regulations" also adjusted the range of penalties. The original "rule" is generally 2-5 times the fine for serious violations of the law, and the new "rule" is 5 to 10 times better, or even 10 to 20 times better, which greatly increases the cost of breaking the law and significantly improves the deterrent effect.

Key words:

medical instruments