1, enter the market supervision bureau class II medical device office platform to view all the details of the process;
2, use the legal person's account login, because it is necessary to associated with the enterprise information in order to normalize the process;
3, through the audit can be issued class I and II medical filing certificate, print out by yourself can be.
The materials required for the second class of medical equipment record certificate are as follows:
1, the second class of medical equipment business record form;
2, a copy of the business license and organization code certificate;
3, the legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity of the person in charge of a copy of the certificate of qualifications or professional title;
4, the organization and departments Setting description;
5, the scope of business, business mode description;
6, business premises, warehouse address of the geographic location map, floor plan, documents proving ownership of the house or a copy of the lease certificate issued by the housing rental agency;
7, business facilities, equipment directory;
8, business quality management system, work procedures and other documents directory;
9, business quality management system, work procedures and other documents;
9, the legal representative of the quality person in charge of identification, education, or a certificate of quality. /p>
9, proof of authorization of the operator.
In summary, the company operating medical devices is required to provide the product registration certificate of the products operated by the company, this is also for the filing of Class II medical devices is a necessary material. Only regular qualified manufacturers will have this thing, so this is a dealer in the choice of manufacturers need to pay attention to one point. Only manufacturers with product registration certificates as well as medical device production licenses, wholesale out of the product is qualified; engaged in the operation of Class II medical devices, business enterprises 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.
Legal basis:
"Chinese People's Republic of China*** and the State Medical Devices Supervision and Administration Regulations"
Article 21
has been registered for the second class, the third class of medical device products, its design, raw materials, production processes, scope of application, use of methods and other substantial changes that may affect the safety and effectiveness of the medical device, the registrant shall Apply to the original registration department for a change in registration procedures; other changes, should be in accordance with the provisions of the State Council drug supervision and management department for the record or report.