Application requirements
Units engaged in the business (retail) of Class III medical devices may apply for the business license of medical devices for approval by other departments before the approval of their own departments: they shall obtain a business license (enterprises that do not indicate the "organization code certificate number" in the business license shall also obtain an organization code certificate). Necessary conditions for the examination and approval of matters: medical device business enterprises meet the requirements of "Quality Management Standard for Medical Device Business" and "Guiding Principles for On-site Inspection of Quality Management Standard for Medical Device Business".
Materials to be prepared when applying.
1, sample of application form for medical device business license
2. Copy of business license
3. Copy of organization code certificate
4, the legal representative of the enterprise, the person in charge of the enterprise identity, education, professional title certificate copy.
5. Copies of ID cards, resumes, academic certificates and technical title certificates of quality management personnel, and on-the-job or part-time labor contracts signed by myself.
6. Medical device retail enterprises that intend to operate contact lenses (excluding orthokeratology lenses) and their care solutions shall provide copies of professional and technical personnel's ID cards, academic certificates with academic qualifications, professional title certificates with professional titles and relevant qualification certificates; Personnel with employment access positions in the country must pass the vocational skill appraisal and obtain a valid vocational qualification certificate before they can take up their posts.
7. List of company personnel (indicating name, gender, age, education, position, professional title and ID number)
8, "medical device management quality management standard self-inspection table" example
9, organization and department settings
10, description of business scope and mode of operation
1 1. Directory of operating facilities and equipment
12. The lease agreement of the business premises and warehouse address of the proposed enterprise, a copy of the property right certificate of the house, the plan (indicating the area) and geographical location map of the business premises and warehouse address.
13, management quality management system, working procedures and other documents.
14. Basic introduction and function description of computer information management system, with purchase invoice attached.
15, agent authorization certificate
16. Copies mentioned in the above materials shall be submitted to the original.
17. Statement on the authenticity guarantee of the application materials for the administrative license (administrative confirmation) of the proposed enterprise; All application materials are required to write page numbers, and the sample table of page number range is indicated in the authenticity guarantee statement.
Application processing flow
(a) to review the application materials, check whether the application materials are complete and conform to the statutory form:
1. The application matters fall within the authority of this organ, and if the application materials are complete and conform to the statutory form, it shall be accepted;
2. If the application materials are incomplete or inconsistent with the statutory form, the applicant shall be informed of all the contents that need to be corrected on the spot or within five working days. If the application materials are not informed within the time limit, it shall 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, the application matters do not belong to the scope of authority of the department, it shall immediately make a decision not to accept, and inform the applicant to apply to the relevant administrative departments.
(two) the examination and approval department shall complete the data review and on-site review within 20 working days from the date of acceptance, and make a decision on whether to issue the medical device business license. For qualified medical device business (retail) enterprises, if they publicize the relevant contents to the public on the website or office of the Food and Drug Administration, and have not received complaints, reports or other objections within 5 days from the date of publicity, they will issue the Medical Device Business License to the applicant within 10 days from the date of making the decision.
For unqualified medical device business (retail) enterprises, notify the applicant in writing and 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. Those who engage in the business (retail) activities of the third kind of medical devices shall first apply for a business license (an enterprise that does not indicate the "organization code certificate number" on the business license shall also obtain an "organization code certificate"), and then apply for a 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, the newly established independent business premises, shall apply for a medical device business license.
4. The third category of management medical devices that may meet the retail conditions are mainly distributed in the following subcategories: 68 15 injection puncture devices (disposable sterile syringes and needles), 6822 medical optical devices (soft contact lenses and nursing fluids), 6825 medical high-frequency instruments and equipment (high-frequency physiotherapy devices), 6840 in-vitro diagnostic reagents (self-use molecular diagnostic reagents), 6854 operating room and first aid.