According to the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Management, enterprises engaged in the management of Class II medical devices shall file with the municipal drug regulatory department where the district is located, and determine the operator's filing certificate.

Those who engage in medical device trading activities without filing a record will confiscate illegal income, illegal medical devices and tools, equipment, raw materials and other articles used for illegal production and business; If the value of the illegally traded medical devices is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; If the value of the goods is not less than 10,000 yuan, a fine of not less than 10 times but not more than 20 times the value of the goods shall be imposed; If the circumstances are serious, the application for medical device license submitted by the relevant responsible person and enterprise shall not be accepted within 5 years.

1. Copy of business license

2, legal representative, responsible person, quality responsible person identity, education, title certificate copy

3. Organization chart

4. Geographical location map, floor plan, proof of property rights or lease agreement of premises and warehouse (with proof of property rights)

5, operating equipment list

Remarks: As a municipal administrative business, the requirements vary from place to place, and the details are subject to the regional municipal requirements.

Expected period of Class II business filing: 1-1.5 months