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Medical device company registration process
The medical device industry involves many industries such as medicine, machinery, electronics and plastics. It is a multi-disciplinary, knowledge-intensive and capital-intensive high-tech industry. Class 1 medical devices can be sold directly; Class 2 requires a license to operate.
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Medical device company registration process China Sourcing agent for Medical device products
1. Pre-approval of the business name;
2. Sign the industrial and commercial registration materials;
3. Open a special account for capital verification to go through the capital verification formalities and issue a capital verification report;
4. Apply for a permit;
5. Apply for business registration;
6. Engraving the official seal and other required seals;
7. Handling tax registration;
8. Open a bank basic account (tax account);
9. Handling tax registration;
10. Go to the tax department to apply for general taxation qualification;
11. Go to the tax department to verify the tax type and purchase the invoice;
Materials required for the establishment of second and third types of medical device operating enterprises
1. "Xi'an Medical Device Business Enterprise License Application Form";
2. Registration Form for Medical Device Business Enterprise License Application Materials;
3. A copy of the pre-approval certificate of the enterprise name issued by the administrative department for industry and commerce or a copy of the Business License;
4. A copy of the ID card, academic qualification or professional title certificate and personal resume of the person in charge of the quality management of the company;
5. A copy of the ID card, academic qualification or title certificate of the company's quality management personnel;
6. The functions of the organization and functions of the enterprise or the full-time quality management personnel;
7. A copy of the geographical location map, floor plan (specify area), house property certificate or lease agreement (with proof of ownership of the leased house) of the registered address and warehouse address of the company;
8. The company plans to set up product quality management system documents and storage facilities and equipment catalogues;Chinese Sourcing agent for Medical device products
9. The scope of business of the company to be established shall be determined according to the management category and class code name specified in the medical device classification catalogue;
10. Electronic filing materials;
What are the registration procedures for medical devices?
Medical device registration process:
1. First, go to your city's Food and Drug Administration to receive the application form and electronic text (also available on the website). Then prepare according to the following materials.
Application materials:
(1) Application Form for Medical Device Manufacturing Enterprise License (Starting);
(2) Basic information and qualification certificates of the legal representative and the person in charge of the enterprise, including identification of identity, academic certificate, certificate of title, copy of appointment document, and work resume;
(3) The original and a copy of the business name approval notice or business license issued by the administrative department for industry and commerce;
(4) Production site certification documents, including a copy of the property certificate or lease agreement and the property certificate of the leased party, the general plan of the plant, and the layout of the main production workshop. Workshops with cleanliness requirements shall indicate the function room and human logistics direction; (5) Copy of the person in charge of the production, technology and quality department of the enterprise, copy of academic qualifications and title certificate; relevant professional and technical personnel, technical worker registration form, certificate copy And indicate the department and position; the proportion of high, medium and junior technical personnel; a copy of the internal auditor's certificate;
(6) Introduction to the product range, variety and related products to be produced. The product brief includes at least the description of the structural composition, principle, intended use and product standards of the product;
(7) A list of major production equipment and inspection instruments;
(8) Catalogue of production quality management norms: including documents such as procurement, acceptance, production process, product inspection, warehousing, delivery, quality tracking, user feedback, adverse event monitoring and quality accident reporting system, and corporate organization chart; 9) Process flow chart of the product to be produced, and indicate the main control items and control points. Description of equipment, personnel and process parameter controls including key and special processes;
(10) If it is intended to produce sterile medical devices, it is necessary to provide a qualified test report for the clean room. A qualified inspection report in accordance with the "Standards for the Management of Sterile Medical Devices" (YY0033) issued by a testing agency approved by the provincial food and drug supervision and administration department within one year;
(11) Self-assurance statement on the authenticity of the application materials. List the list of application materials and make a commitment to the material if it is legally and legally liable.
2. Secondly, your product needs a type of medical device registration certificate: The first type of medical device registration application materials (1) Domestic medical device registration application form;
(2) Qualification certificate of medical device manufacturing enterprise: copy of business license;
(III) Applicable product standards and explanations: If national standards and industry standards are adopted as applicable standards for products, the texts of the adopted national standards and industry standards shall be submitted; the registered product standards shall be signed by the production enterprises. The production enterprise shall provide a statement that the applied product conforms to the national standards and industry standards, and the manufacturer shall bear the statement of the quality responsibility after the product is listed and the description of the product model and specification. The [signature" here means: the seal of the enterprise, or the signature of the legal representative and the person in charge, plus the seal of the enterprise (the following refers to the domestic medical device, the meaning is the same);
(4) Test report of full performance of the product;
(5) A description of the existing resource conditions and quality management capabilities (including testing means) of the products produced by the enterprise;
(6) Medical device instructions;
(7) Self-guarantee statement on the authenticity of the submitted materials: It should include a list of the submitted materials and a commitment of the production enterprise to assume legal responsibility.
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