1. Need to fill in the Application Form for Medical Device Business License and print it out for signature;
2. A copy of the business license and organization code certificate is required;
3. Prepare a copy of the identity certificate, education or professional title certificate of the person in charge of the legal person or enterprise;
4. Need to prepare proof of organization and department establishment;
5. Description of the business scope and mode of operation of the enterprise;
6. The plan and location map of the company's business premises and warehouse address, and a copy of the lease agreement of the house property right certificate;
7, the need for facilities and equipment directory;
8, enterprise management system and working procedure file directory;
9. Entrusting documents and other materials.
II. Procedures for Shanghai's Class III Medical Device Business License
1. enterprise application: it is necessary to submit an application form to the relevant departments, upload the attachments required for the work guide, and submit the application materials;
2. Online audit: there will be a pre-trial message reply within a few working days, and the enterprise can enter the password.
Check the website;
3. Submission of materials: After passing the preliminary examination, bring materials to the local acceptance department to submit materials;
4. On-site verification: From the date of acceptance, the management department needs to be present for verification. Examination and approval after examination;
5. Online publicity: information needs to be publicized on relevant websites, and the administrative examination and approval service center of the Food Supervision Department of the Municipal Bureau will issue a certificate.