Legal analysis: need to "set up a medical device business license"
(a) apply for the establishment of a medical device business enterprise report, fill out or print the "Medical Device Business License Application Form" (four copies);
(b) the administrative department for industry and commerce issued the "pre-approval of the enterprise name notification";
(c) the information of personnel;
1, the proposed legal representative and the person in charge of the enterprise's identity card, household register or relevant certificates issued by the public security organs and other documents and educational certificates, health certificates;
2, the proposed quality management personnel of the enterprise's identity card, copies of certificates of academic or professional and technical positions and individual practitioner's resume, employment agreement, and health certificates;
3, the proposed enterprise personnel Roster, and health certificates. The content of the roster includes: name, gender, age, professional and technical position/education, position/post.
(d) the proposed enterprise organization and functions;
enterprises to develop the organizational structure of the block diagram, clearly and unambiguously identifies the internal division of labor within the enterprise, as well as the functions of the enterprise personnel positions.
(E) the proposed enterprise registered address, warehouse address of the geographical location map, floor plan (indicating the area), proof of ownership of housing (or lease agreement) copy.
(F) the proposed enterprise product quality management system documents and storage facilities, equipment catalog;
(G) the proposed enterprise business varieties catalog;
Catalog includes the following: product name, manufacturer, specifications, registration certificate number, and the corresponding product storage conditions, requirements of the description.
Legal basis: "Supervision and Administration of Medical Device Network Sales" Article 4 Enterprises engaged in the online sale of medical devices, medical device network trading services third-party platform provider shall comply with medical device laws, regulations and norms, establish and improve the management system, in accordance with the law and integrity of the business, to ensure the quality and safety of medical devices.
Enterprises engaged in the sale of medical devices network, refers to the medical device marketing license holder (i.e., medical device registrant or filer, hereinafter referred to as the holder) and medical device production and management enterprises through the network sales of medical devices.
The third-party platform provider of medical device network trading services refers to the enterprise that only provides trading services such as web space, virtual trading place, trading rules, transaction aggregation and electronic order in medical device network trading for trading parties or multiple parties to carry out trading activities without directly participating in the sale of medical devices.
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