Which drug management is more standardized, Class I medical devices or Class II medical devices?

Class II medical devices are relatively strictly controlled. The regulations point out:

Article 8: Class I medical devices are subject to product registration management, and Class II and III medical devices are subject to product registration management.

Article 21: Those engaged in the production of Class I medical devices shall register with the food and drug supervision and administration department of the people's government of the districted municipality where they are located and submit their compliance with the provisions of Article 20 of these Regulations Documentation proving conditions.

Article 22: To engage in the production of Class II and Class III medical devices, the manufacturing enterprise shall apply for a production license to the food and drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where it is located and submit its production license in compliance with this provision. Documents proving the conditions specified in Article 20 of the Regulations and the registration certificate of the medical devices produced.

As well as the business quality management regulations: Article 4: According to the risk level of medical devices, medical device operations are subject to classified management.

The operation of Class I medical devices does not require licensing and registration, the operation of Class II medical devices is subject to filing management, and the operation of Class III medical devices is subject to licensing management.