Two different certificates need to apply for a business license first, and then they need to be registered because they are special medical device industries.
Engaged in the operation of second-class medical devices, the operating enterprise shall file with the municipal food and drug supervision and administration department located in the district, fill in the filing form for the operation of second-class medical devices, and submit the following materials:
1. Copy of business license and organization code certificate.
2 copies of the identity certificate, education or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality.
3. Description of organization and department settings.
4. Description of business scope and mode of operation.
5. A copy of the geographical location map, floor plan, house title certificate or lease agreement (with house title certificate attached) of the business premises and warehouse address.
6. Catalogue of operating facilities and equipment.
7. Directory of documents such as operation quality management system and working procedures.
8. Agent's authorization certificate.
9. Other supporting materials.
reference data
Filing of Class II medical devices. Filing of Class II medical devices [citation time: 2018-1-1]