Requirements for application
Units engaged in the business (retail) of Class III medical devices can apply for the Medical Device Business License, which needs to be examined and approved by other departments before being examined and approved by their own departments: they should obtain the Business License (enterprises that do not indicate "Organization Code CertificateNo." in the Business License should also obtain the Organization Code Certificate). Necessary conditions for the examination and approval of matters: medical device business enterprises meet the requirements of the quality management standards for medical device business and the guiding principles for on-site inspection of the quality management standards for medical device business.
materials to be prepared for the application
1. Sample form of Application Form for Medical Device Business License
2. Copy of Business License
3. Copy of Organization Code Certificate
4. Copy of identity, education background and professional title certificate of the legal representative and person in charge of the enterprise
5. ID card of quality management personnel. I signed a medical device retail enterprise that is on-the-job and not part-time, and has a labor contract
6. I intend to operate contact lenses (excluding orthokeratology contact lenses) and their nursing fluids, and provide a copy of professional and technical personnel's ID card, a copy of academic certificate with academic qualifications, a copy of professional title certificate with professional titles and a copy of relevant qualification certificates; Personnel who have employment access posts in the country must pass the vocational skill appraisal and obtain a valid vocational qualification certificate before they can take up their posts.
7. Name list of company personnel (indicating name, gender, age, education background, position, professional title and ID number)
8. Example of Self-inspection Form of Medical Device Management Quality Management Specification
9. Description of organization and department setting
1. Description of business scope and mode
11. Catalogue of business facilities and equipment. The address plan (indicating the area) and geographical location map of the business premises and warehouses
13. Catalogue of documents such as management quality management system and working procedures
14. Basic introduction and function description of the computer information management system, with purchase invoice
15 and authorization certificate of the manager
16. The copies mentioned in the above materials need to be submitted to the original
17. The proposed enterprise is responsible for the administration. All application materials are required to write page numbers, and the range of page numbers should be indicated in the statement of authenticity assurance.
Sample application process
(1) Review the application materials to check whether the application materials are complete and conform to the legal form:
1. If the application matters fall within its scope of authority and the application materials are complete and conform to the legal form, the application shall be accepted;
2. If the application materials are incomplete or do not conform to the statutory form, the applicant shall be informed of all the contents that need to be corrected on the spot or within 5 working days. If the application materials are not informed within the time limit, it will be accepted as of the date of receipt of the application materials; 3. If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;
4. If the application matters do not fall within the scope of functions and powers of the department, it shall immediately make a decision of rejection, and inform the applicant to apply to the relevant administrative department.
(2) The examination and approval department shall complete the data review and on-site review within 2 working days from the date of acceptance, and make a decision on whether to issue the Medical Device Business License. To meet the requirements of the medical device business (retail) enterprises, in the website or office of the Food and Drug Administration to the public related content, within 5 days from the date of publicity, did not receive complaints, reports or other objections, within 1 days from the date of making a decision, the applicant issued a "medical device business license".
for medical device business (retail) enterprises that do not meet the requirements, notify the applicant in writing, explain the reasons, and inform the applicant that he has the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
Important note:
1. To engage in the business (retail) activities of the third kind of medical devices, you should first apply for the Business License (the enterprise that does not indicate the "organization code certificate number" in the Business License should also obtain the Organization Code Certificate), and then apply for the Medical Device Business License.
2. The business license must be of an enterprise nature, and individual industrial and commercial households cannot apply for the Medical Device Business License.
3. If an independent business place is newly established, it shall apply for a medical device business license separately.
4. The third category of management medical instruments that may meet the retail conditions are mainly distributed in the following sub-categories: 6815 injection puncture instruments (disposable sterile syringes and needles), 6822 medical optical instruments (soft contact lenses and nursing fluids), 6825 medical high-frequency instruments and equipment (high-frequency physiotherapy instruments), 684 in-vitro diagnostic reagents (molecular diagnostic reagents for personal use), 6854 operating room and emergency room.