The qualification of the second class of medical equipment for the record, not in the local business license.
Two different documents, the first for the business license is a must for business documents, and then because of the medical device special industry need to be registered for the record.
Engaged in the second class of medical equipment business, business enterprises should be located in the municipal food and drug supervision and management department for the record, fill out the second class of medical equipment business filing form, and submit the following information:
1. Business license and a copy of the organization code certificate.
2. Legal representative, the person in charge of the enterprise, the quality of the person in charge of the identity card, education or title certificate copy.
3. Organizational structure and departmental settings.
4. Description of the business scope and mode of operation.
5. Business premises, warehouse address of the geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copy.
6. Business facilities, equipment catalog.
7. Business quality management system, work procedures and other documents catalog.
8. Proof of authorization of the operator.
9. Other supporting materials.
References
The second class of medical devices for the record. Class II medical device filing[cited 2018-1-11]