Then you have to register a medical device company, the process of registering a medical device company (in Shanghai, for example)
1, submit the "pre-approval of the enterprise name notice";
2, submit the application materials to the Shanghai Municipal Food and Drug Administration;
3, the material review and approval of the Pharmaceutical Supervision and Administration Bureau of appointments and inspection of the business site;
4, submit written application materials, audit and approval of the issuance of "medical device business enterprise license";
5, the opening of the capital verification account, the shareholders to contribute, the accounting firm issued a capital verification report;
6, for the business license
7, engraved company seal;
8, for the organization code certificate;
9, for the tax registration certificate;
Medical equipment company registration time in 40-50 working days.
Then, you have to hold a medical device registration certificate and a medical device production license if you want to produce medical devices.
What materials or information should I prepare for the registration certificate of medical devices?
1, first of all, go to your city Food and Drug Administration, get the application form and electronic text (you can also download from the website). Then prepare the materials according to the following.
Declaration materials (1) "Medical Device Manufacturer License" (start-up) application form;
(2) the legal representative, the person in charge of the enterprise's basic information and proof of qualifications, including proof of identity, proof of academic qualifications, proof of title, a copy of the appointment documents, work resume;
(3) business administration department issued a notice of approval of the enterprise name or Original and copy of business license;
(4) documents proving the production site, including copies of property certificates or lease agreements and property certificates of the leased party, the general layout of the factory, and the layout of the main production workshops. Workshops with clean requirements, must be marked with functional rooms and human flow towards;
(5) the enterprise's production, technology, quality department responsible for the resume, a copy of the certificate of qualifications and titles; relevant professional and technical personnel, skilled workers registration form, a copy of the certificate, and indicate the department and position; the proportion of senior, middle and junior technical personnel table; a copy of the certificate of the internal auditor;
(6) the scope of products to be produced, varieties and related product profile. Product profile at least includes a description of the product's structural composition, principle, intended use and product standards;
(7) the list of major production equipment and inspection instruments;
(8) production quality management standardized documents catalog: including procurement, acceptance, production process, product inspection, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality accident reporting system and other documents, enterprise organization chart;
(9) the production of the product range, variety and related products. Documents, enterprise organization chart;
(9) the process flow diagram of the proposed product, and indicate the main control items and control points. Including critical and special process equipment, personnel and process parameters control instructions;
(10) proposed production of sterile medical devices, need to provide a clean room qualified test report. Recognized by the provincial food and drug supervision and management department of the testing agency issued within one year in line with the "production of sterile medical devices management norms" (YY0033) of the qualified test report;
(11) application materials for the authenticity of the self-assurance statement. Listed in the declaration materials catalog, and the material to make a commitment to bear legal responsibility if false. 2, followed by your product needs to have a class I medical device registration certificate:
The first class of medical device registration application materials
(a) the territory of the application form for registration of medical devices;
(b) proof of qualification of medical device manufacturers: a copy of the business license;
(c) the applicable product standards and descriptions: the use of national standards, industry standards as products of the Applicable standards, should be submitted to the text of the adopted national standards, industry standards; registered product standards should be signed by the manufacturer. Manufacturing enterprises should provide the application for products in line with national standards, industry standards, the statement that the manufacturer assumes responsibility for the quality of the product on the market, as well as the product model, specifications and division of the description. Here the "seal" means: enterprise seal, or its legal representative, the person in charge of the signature and enterprise seal (the following medical devices involved in the territory, the same meaning);
(d) the full performance of the product test report;
(e) the production of products of the enterprise's existing resources and quality management capabilities (including) the description of the means of testing;
(f) the production of products and quality management capacity (including) Testing methods) of the description;
(F) medical device instructions;
(VII) submitted by the authenticity of the self-assurance statement: should include a list of materials submitted, the commitment of the manufacturer to assume legal responsibility. 3, the Technical Supervision Bureau to apply for testing