1, "Class II medical device business filing application form" 1 original;
2, a copy of the business license;
3, legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of the certificate, a copy of the certificate of academic qualifications or professional titles;
4, the organizational structure and the departments Set up a description;
5, the scope of business, business mode description of the original 1;
6, business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or a copy of the lease agreement (with documents proving ownership of the house) 1;
7, business facilities, equipment directory 1;
8, the "enterprise power of attorney
8, "the original letter of authorization for the enterprise" and a copy of the operator's identity card (only the entrusted need to provide);
9, declaration of authenticity of the material self-assurance statement of the original;
10, medical device business enterprise practitioners and meet the relevant qualification requirements of the quality of management, operation and other key positions in the qualification of personnel materials.
Regulatory requirements for medical devices:
Strengthening the supervision and management of medical device registrants, clarifying the responsibilities of both registrants and commissioned manufacturers, incorporating the relevant requirements for commissioned production management into the quality management system, and further improving the regulatory requirements for inspection duties, inspection methods, disposal of results, and investigation and collection of evidence in the production of medical devices. Improve the management requirements of sales, transportation, storage and other aspects of the business process, refine the import inspection, sales records and other relevant provisions of traceability management, and strengthen the registrant, the filing of the sale of its registration, filing of the quality and safety of medical devices responsibility.
In summary, Class II medical device business filing need the above information, should ensure that the information submitted is legal, true, accurate, complete and traceable.
Legal basis:
"Supervision and Administration of Medical Device Production" Article 10
In the territory engaged in the production of Class II and Class III medical devices, shall apply to the local provincial, autonomous regions and municipalities directly under the central drug supervision and management department for a license to produce, and submit the following materials:
(a) the registration certificate of the medical device produced, as well as the technical requirements of the product Copies;
(ii) legal representative (person in charge of the enterprise) a copy of identification;
(iii) production, quality and technical personnel in charge of the identity, education, title copies of relevant materials;
(iv) production management, quality inspection positions of practitioners, education, title list;
(v) copies of the relevant documents of the production site, there are special production environment requirements, should also be submitted to the facilities, environment, copies of relevant documents;
(vi) the main production equipment and inspection equipment catalog;
(vii) quality manuals and procedural documents catalog;
(viii) the production process flow chart;
(ix) proof of after-sales service capacity of the relevant materials;
(j) the operator of the authorization documents.