1, submit an application for filing. According to the relevant regulations, 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 person in charge of the enterprise, the person in charge of quality of proof of identity, education or title certificate copies, as well as the enterprise warehouse address of the house property rights documents and lease agreements and other information;
2, Review. After the submission of materials, food and drug supervision and management department will be on the spot on the integrity of the information submitted by the enterprise to check, the application materials are complete and in accordance with the statutory form, then accept the record information, and issued to the enterprise class II medical device business record voucher.
The second class of medical equipment business filing certificate for the materials:
1, "Medical Device License Application Form" (original 1);
2, "Business License" (copy);
3, Organization Code Certificate (copy);
4, legal representative, responsible person for business, the person in charge of quality of identification, education or professional title (copy).
5, quality management personnel's work resume (1 original);
6, list of professional and technical personnel (1 original) and professional and technical personnel's identity card, proof of academic qualifications, professional title certificates (a copy of each);
7, organization and departmental setup description;
8, Description of the business scope, mode of operation;
9, business premises, warehouse address of the geographic location map, floor plan, documents proving ownership of the house or by the housing lease issued by the housing lease certificate copy. Is warehousing commissioned by the third-party logistics of medical devices, provide a commissioning contract (a copy);
10, business facilities, equipment catalog.
In summary, the second class of medical devices business record certificate procedures, submit the record application. According to the relevant regulations, engaged in the operation of Class II medical devices, the business enterprise should be located in the municipal food and drug supervision and management department for the record, fill out the Class II medical device business filing form, and submit the person in charge of the enterprise, the person in charge of quality of proof of identity, education or title certificate copies, as well as the enterprise warehouse address of the house property rights documents and lease agreements and other information.
Legal basis:
"Supervision and Administration of Medical Devices Regulations," Article 21
Registered Class II, Class III medical device products, its design, raw materials, production processes, scope of application, methods of use, etc., substantial changes that are likely to affect the safety of the medical device, effective, the registrant shall apply to the original registration department to apply for a change in the registration formalities Other changes, should be in accordance with the provisions of the State Council drug supervision and management department for the record or report.