Interpretation of Applicable Requirements for Medical Device Products, Production and Operation

Release time:

2020-07-03 11:38

With the reduction of the level of emergency response to the prevention and control of the new coronary pneumonia epidemic, the local drug administrations have stopped the acceptance of emergency review and approval of medical device registration since March 1, 2020. What are the requirements for filing/registration/licensing of products/production/operation of medical devices of different categories?

The state implements classified management of medical devices according to the degree of risk (* For specific classification, please refer to the "Medical Device Classification Rules" (China Food and Drug Administration Order No. 15))

The first category is a low degree of risk, the implementation of regular management can ensure its safety and effectiveness of medical devices.

The second category is a medical device with moderate risk and requires strict control and management to ensure its safety and effectiveness.

The third category is medical devices with high risk, which need to take special measures to strictly control and manage to ensure their safety and effectiveness.

1. products

Medical device products use a classification management system for filing/registration. The first category of medical device products is suitable for product filing, and the second and third categories are suitable for product registration.

l Domestic production products

For the filing of the first category of medical device products, the filing person can submit the filing materials to the food and drug supervision and administration department of the municipal people's government with districts. Under the premise that the materials meet the requirements, the general processing time limit is not more than 5 working days (There are differences between regional management departments).

For the registration of Class II medical device products, the registrant shall submit the registration application materials 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. The acceptance department shall make an approval decision within 20 working days after receiving the technical review opinions.

For the registration of Class III medical device products, the registrant shall submit the registration application materials to the Food and Drug Administration of the State Council. The acceptance department shall make an approval decision within 20 working days after receiving the technical review opinions.

l Products imported from abroad

The filing/registration of imported products shall be submitted to the food and drug administration department of the State Council. In addition to the corresponding filing/registration materials, it is also necessary to submit the certification documents of the competent department of the country (region) where the medical device is allowed to go on the market, and the representative office established in China or the designated domestic enterprise legal person shall act as the agent.

2. production

l The first type of medical device production is applicable to record management: the production enterprise shall file with the food and drug supervision and administration department of the municipal people's government with districts and submit the certification materials that meet the requirements.

l The second and third categories of medical device production are applicable to production license management: the production enterprise shall apply to the food and drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the central government for production license and submit the certification materials that meet the requirements. After examination and approval to meet the conditions, issued a medical device production license, valid for 5 years.

3. operation

l Class I medical device business without filing or business license

l The second type of medical device business is subject to filing management: the operating enterprise shall file with the food and drug supervision and administration department of the municipal people's government with districts and submit the certification materials that meet the requirements.

l The third category of medical device production is subject to business license management: the business enterprise shall apply to the food and drug supervision and administration department of the municipal people's government with districts for business license and submit the certification materials that meet the requirements. After examination and approval to meet the conditions, issued a medical device business license, valid for 5 years.

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