The operation of Class II medical devices need to be filed by the municipal bureau, issued by the record certificate.
The operation of Class III medical devices need to be licensed by the municipal bureau, issued a license.
From October 1, 2014, the Medical Device Business License must be declared online and passed after on-site assessment.
From the Food and Drug Administration website home page, "online business" section of the "medical device production and operation license filing information system" click to enter.
After entering the landing page, there is a special operation manual and tutorial video download interface, the applicant enterprise can download and use.
Application for licensing matters for the record, in addition to the system should be completed in the online declaration, but also paper materials should be submitted to the appropriate approval and filing department before processing.
Note: 1. Business license is not allowed to apply for a medical device business license if it is not a business, it is an individual business.
(Individual) business license can be upgraded to the Business and Industry Bureau for business. Specific steps are: first to the industrial and commercial bureau of the industrial and commercial office of the management of the piece of registration, fill out the form, and then take the relevant materials to the hall of government for the upgrade of the business license, upgraded to the enterprise, and then apply for the organization code certificate, and then to the online declaration.
2. "Medical Device Filing Application Form" need to submit electronic materials, which add * for the required items.
Electronic materials upload only support the upload of pictures and pdf format materials.
1. * business license and organization code certificate copy
2. * legal representative, the person in charge of the enterprise, the quality of the person in charge of the identity, education or title certificate copy
3. * organization and departmental setup description
4. * scope of business, the business mode description
5. * business premises, depot address Geographic location of the map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copies
6.* Business facilities, equipment catalog
7.* Business quality management system, work procedures and other documents
8. Computer information management system basic information and functional description
9.* Authorization of the operator Proof
10. * Signed and stamped scanned application form
3. The difference between licensing and filing is that the license must have item 8: basic information on the computer information management system and functional description, and a computer management system.