Medical devices must be pre-approved before filing. At present, the food and drug administration is generally responsible for the pre-approval of the medical device industry. It is necessary to fill in the Application Form for Internet Drug Information Service issued by the State Food and Drug Administration of the United States, apply to the website organizer (food) drug supervision and administration department, and submit the following materials: 1 Copy of the business license of the enterprise. Relevant certificates or documents of website domain name registration. Description of website column setting (application) 4. Methods and operating instructions for the food and drug supervision and administration department to browse all columns and contents of the website online; 5. Description of the relevant management system and implementation of historical release information backup and query websites; 6. A copy of the diploma or professional technical qualification certificate of the professional and technical personnel related to drugs and medical devices, and a copy of the ID card and resume of the person in charge of the website; 7. Sound network and information security measures, including website security measures, information security management system and user information security management system; 8. Management measures, explanations and relevant certificates to ensure the legality, truthfulness and safety of drug information sources.
After the pre-approval, I will send you a copy of the pre-approval document (pre-approval number), a copy of the business license of the enterprise, a copy of the ID card of the person in charge of the website, a photo of the person in charge of the website, a domain name certificate, a verification form, an icp information registration form, an information security agreement, a website authorization letter and documents. These materials can be sent to your space provider after being stamped with the official seal of the company, so that the space access provider can help you put on record.
The filing time is generally within 7-20 working days.
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Pre-approval is difficult to approve. If you can't get the pre-approval, follow the ordinary filing process, but you can't open the website during the filing period, and the website name doesn't involve medical devices during the review period, and you can change it back after filing. You can also choose not to archive the space outside the network. Many medical device industries choose foreign space, or put it on record first, and then put the website on it.