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 to log in, because it is necessary to associate with the enterprise information in order to normalize the process;
3, the audit can be issued through the Class II medical filing certificate, print it out by yourself can be.
The materials required for Class II medical device filing certificate are as follows:
1, Class II medical device business filing 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 quality of the identity of the person in charge of a copy of the certificate of qualifications or titles;
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:
"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, use of methods and other substantial changes that are likely to affect the safety of the medical device, effective, the registrant should be registered to the original registration department to apply for changes in the 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.