Hello, the question you asked about "How to log in to the electronic medical device management system on the Wuxi Food and Drug Administration website" refers to the online declaration page? In fact, regarding this issue, the Wuxi Food and Drug Administration website clearly states that the application must be filled out through the Wuxi Food and Drug Administration administrative licensing online application platform. Detailed information is in the "Second" section of the website. There are instructions on "First Registration of a Medical Device Business Enterprise" and "Application for a Medical Device Business License (Retail)".

Required conditions for application

Units engaged in the business (retail) of Class III medical devices can apply for a "Medical Device Business License". They need to go to other departments before applying for approval from this department. Approval: Obtain the "Business License" (enterprises that do not indicate the "Organization Code Certificate Number" on the "Business License" should obtain the "Organization Code Certificate" at the same time). Necessary conditions for approval of matters: Medical device operating enterprises must meet the requirements of the Medical Device Operations Quality Management Standards and the Medical Device Operations Quality Management Standards on-site inspection guiding principles.

Materials required for application

1. Sample "Medical Device Business License Application Form"

2. Copy of "Business License"

3. A copy of the "Organization Code Certificate"

4. A copy of the identity, academic qualifications and professional title certificates of the legal representative of the enterprise and the person in charge of the enterprise

5. Quality Copies of management personnel’s ID cards, resumes, academic certificates and technical title certificates, and signed employment contracts (not part-time or part-time) and employment contracts

6. Plan to operate corneal contact lenses (excluding corneal plastic contact lenses) Medical device retail enterprises (mirrors) and their care solutions must provide copies of ID cards of professional and technical personnel, copies of academic certificates with academic qualifications, copies of certificates with professional titles and relevant qualification certificates; Personnel working in employment access positions must pass a vocational skills appraisal and obtain a valid vocational qualification certificate before they can take up the job.

7. List of company personnel (indicate name, gender, age, education, position, professional title, ID number)

8. "Medical Device Operation Quality Management Standards Self-Check Form" 》Example of article

9. Description of organization and department setup

10. Description of business scope and business methods

11. Catalog of business facilities and equipment

< p>12. Lease agreement for the business premises and warehouse address of the proposed enterprise, a copy of the property ownership certificate, a floor plan of the business premises and warehouse address (indicate the area) and a geographical location map

13. Operation quality management system , work procedures and other document directories

14. Basic introduction and function description of the computer information management system, with purchase invoice attached

15. Authorization certificate of the person in charge

16. The copies mentioned in the above materials need to be submitted to the original for verification

17. The proposed enterprise shall make a statement on the authenticity of the application materials for administrative licensing (administrative confirmation); all application materials are required to be page numbered and authenticated. Sample form indicating the page number range in the Sexual Guarantee Statement

Application Process

(1) Review the application materials to check whether they are complete and in compliance with the legal form:

1. If the application matters fall within the scope of its powers and the application materials are complete and comply with the legal form, the application shall be accepted;

2. If the application materials are incomplete or do not comply with the legal form, the application shall be accepted on the spot or in The applicant will be informed of all the content that needs to be supplemented and corrected within 5 working days. If the applicant is not notified within the time limit, the application will be accepted from the date of receipt of the application materials; 3. If the application materials contain errors that can be corrected on the spot, the applicant should be allowed to correct them on the spot. ;

4. If the application matters do not fall within the scope of the department’s powers, a decision shall be made immediately not to accept the application and the applicant shall be informed to apply to the relevant administrative department.

(2) The approval department will complete the information review and on-site review within 20 working days from the date of acceptance, and make a decision on whether to issue a "Medical Device Business License". For medical device operating (retailing) enterprises that meet the requirements, the relevant content shall be disclosed to the public on the website or office of the Food and Drug Administration. If no complaints, reports or other objections are received within 5 days from the date of publication, on the day the decision is made, A "Medical Device Business License" will be issued to the applicant within 10 days.

For medical device operating (retail) enterprises that do not meet the requirements, the applicant shall be notified in writing and the reasons shall be explained. The applicant shall also be informed of the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.

Important reminder:

1. To engage in Category III medical device business (retail) activities, you should first apply for a "Business License" (the "Business License" does not indicate "Organizational Structure" Enterprises with "code certificate number" 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 a "Medical Device Business License".

3. If a new independent business location is established, a separate application for a medical device business license shall be made.

4. The third category of managed medical devices that may be eligible for retail are mainly distributed in the following classification sub-categories: 6815 injection puncture instruments (disposable sterile syringes and injection needles), 6822 medical optical instruments ( Soft contact lenses and care solutions), 6825 medical high-frequency instruments and equipment (high-frequency physical therapy devices), 6840 in vitro diagnostic reagents (personal molecular diagnostic reagents), 6854 operating room, emergency room, and treatment room equipment and appliances (insulin Pumps, hormone pumps, etc.), 6866 medical polymer materials and products for personal consumption (condoms with functional additives, etc.).