1. "Medical Device Business License Application Form" (1 original);
2. "Business License" (copy);
3. Organizational Code Certificate (copy);
4. Legal representative, responsible person of the enterprise, the person in charge of quality of the identity of the person in charge, Proof of education or title (1 copy);
5. Quality management personnel resume (1 original);
6. Professional and technical staff list (1 original) and professional and technical staff of identity cards, academic certificates, title certificates (1 copy each);
7. Organizational and departmental setup instructions;
8. Business scope, mode of operation description;
9. Business premises, warehouse address location map, floor plan, documents proving ownership of housing or housing lease issued by the housing lease certificate copy. Is warehousing commissioned by the third-party logistics of medical devices, provide a commissioning contract (copy 1,).
10. Business facilities, equipment catalog;
11. Business quality management system, work procedures and other documents catalog. Including procurement, acceptance, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality incident reporting system and other documents (1 original);
12. for medical device license companies have installed computer information management system basic information and functional description , print information management system home page (1 original).
13. Where the application for corporate reporting materials, the person handling the material is not the legal representative or the person in charge of the enterprise himself, the enterprise should submit a "power of attorney" (original 1).
14. Self-assurance statement of the authenticity of the declaration materials, including the catalog of application materials and the enterprise to the material to make a commitment to bear legal responsibility if false (original 1).
Three types of medical equipment business license conditions
1, the business premises should be used area of not less than 40 square meters, the use of the business premises of the branch of the legal entity should be used area of not less than 25 square meters (except across the regional municipalities to set up); business hearing aids, the use of the business premises should be used area of not less than 25 square meters; business contact lenses and nursing fluids, contact lenses and nursing fluid. Business premises should be no less than 10 square meters.
2, the warehouse area should be not less than 30 square meters; the operation of single-use sterile medical devices, the warehouse should be in the same building, the use of the area should be not less than 200 square meters.
3, quality management, quality institutions should have a nationally recognized, and business products related to the profession, college degree or above, or intermediate or higher technical title in related disciplines. Operating single-use sterile medical devices, there should be more than one medical device quality management system internal auditor certificate of internal auditor and other relevant application conditions.
The process of applying for a medical device license
Phase I: application for: drug supervision department to check whether the application information meets the basic requirements, to decide whether to accept or not to accept the decision to apply for; (the application needs to be filled out as many as nearly a hundred copies of the information, acceptance of the application staff, if you find that any one place to fill in the information on the need to return to modify, such as the discovery of major non-conformities are
The second stage: on-site review: that is, the Department of Pharmaceutical Supervision assigned one to three auditors to the business site audits, audits for the on-site questioning and assessment and on-site inspection and assessment, such as a factual record of the audit information and audit conclusions, such as non-compliance with the requirements of the requirements can be requested to rectify the business until the rectification requirements, such as rectification Reng does not meet the requirements of the notice of the disallowance of the permit; (the purpose of the audit) The purpose is: to audit the legality, compliance and authenticity of the business site, such as found not in accordance with the laws and regulations, rules and regulations implemented, the audit conclusion will have a direct impact on whether or not to pass the audit, * the final impact is whether the enterprise can obtain the license qualification)
The third stage: review, publicity, licensing: that is, by the leadership of the drug supervision department to approve the relevant information to decide whether or not to give the enterprise to issue a business license If the review of the relevant website in the relevant information on the enterprise to publicize the public notice of no objection, then notify the enterprise to receive the medical equipment business license.