Medical devices must first apply for pre-approval before the record, now the medical device industry pre-approval is generally in the Food and Drug Administration for, to fill out the State Food and Drug Administration issued a unified "Internet drug information service application form" to the website organizer (food) drug supervision and management department to apply and submit the following materials: 1. business license A copy of the website domain name registration of the relevant certificates or supporting documents 3. website columns set up instructions (apply for operating Internet drug information services for the website is required to provide a fee columns and charges for the description of the way); 4. (Food) drug supervision and management department to browse the website online all the columns, the content of the method and the operation of the instructions; 5. website on the history of the release of information on backup and access to the relevant management systems and Implementation of the description; 6 drugs and medical devices related professional and technical personnel or a copy of their professional and technical qualification certificate, a copy of the identity card of the person in charge of the site and resume; 7. Sound network and information security measures, including website security measures, information security and confidentiality management system, user information security management system; 8. Ensure that the source of information on drugs is legitimate, true, safe management measures The information security management system of the website, including the information security security management system, the user information security management system; 8.
After the pre-approval down, the pre-approval of a copy of the document (pre-approval number), a copy of the business license, a copy of the corporate identity card, a copy of the identity card of the person in charge of the site, the person in charge of the site photo, domain name certificate, verification of the single, icp information registry, the information security agreement, the site authorization, the document can ask you to send your hole space business, the data stamped with the company's official seal! After sent to your space business, let the space access provider to help record
, the record time is generally 7-20 working days.
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Front-end approval is difficult to approve down, if you can not get front-end approval, in accordance with the ordinary filing process to go, but the record period can not open the station, the site name in the audit period do not involve the medical equipment in this regard, such as filing down and then change back. You can also choose to space outside the network is not to record a lot of medical equipment industry is to choose foreign space, or first filed, the record number down and then put the site on the
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