The materials to be submitted are roughly as follows:
(a) "Medical Device Business License Application Form";
(b) the industrial and commercial administration department issued a pre-approval of the enterprise name certificate document or a copy of the business license;
(c) the enterprise's legal representative, the person in charge of the enterprise's basic profile, ID card copy; quality management personnel, After-sales service personnel basic information, identity cards and certificates of education or title copies;
(d) the basic situation of the enterprise, which should include the enterprise premises, warehouses, the basic situation of the personnel, the configuration of the quality management personnel whether the scope of business with the business is appropriate, the enterprise's organizational chart and its related functions, the enterprise can provide after-sales service, the operation of the main types of species categories (according to the "Medical Device Classification Catalogue") and so on. Classification Catalog of Medical Devices"), etc.
(e) the registered address of the enterprise, warehouse address of the geographical location map, floor plan (indicating the area), a copy of the certificate of property rights (or certificate of property rights + lease agreement);
(f) the enterprise product quality management system documents and storage facilities, equipment catalog;
(g) the applicant's statement on the authenticity of the substance of the submitted materials.
These materials are to be submitted to the Food and Drug Administration in your area to apply.
Frida Medical Device Consulting is a professional company specializing in providing one-stop consulting and services for medical device companies, hope it can help you.