The operation of Class II medical devices requires the Municipal Bureau to put on record and issue a record certificate.
The operation of three types of medical devices requires the permission of the Municipal Bureau.
Starting from 20 14, 10 and 1, the medical device business license must be declared online and approved on site.
You can click on the "Medical Device Production and Operation License Filing Information System" in the "Online Service" column on the homepage of the Food and Drug Administration.
After entering the landing page, there is a special operation manual and tutorial video download interface, which can be downloaded and used by the applicant enterprises.
When applying for licensing matters, it is necessary not only to complete the online declaration in the system, but also to submit paper materials to the corresponding examination and approval and filing departments before handling it.
Note: 1. If the business license is not an enterprise but an individual industrial and commercial household, it is not allowed to apply for a medical device business license. The (individual) business license can be upgraded to the Industrial and Commercial Bureau. The specific steps are: first go to the industrial and commercial office in charge of the industrial and commercial bureau to register and fill in the form, then take the relevant materials to the government hall to upgrade the business license to an enterprise, then apply for the organization code certificate, and then declare online.
2. Electronic materials to be submitted in the medical device filing application form, in which * is required.
Upload of electronic materials only supports uploading of materials in the form of pictures and pdf.
1.* Copy of business license and organization code certificate
2 * A copy of the identity certificate, education or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality.
3.* Description of organization and department settings
4 * Description of business scope and mode of operation
5 * A copy of the geographical location map, floor plan, house title certificate or lease agreement (with house title certificate attached) of the business premises and warehouse address.
6 * Catalogue of operating facilities and equipment
7.* Manage the catalogue of documents such as quality management system and working procedures.
8. Basic introduction and functional description of computer information management system
9.* Agent's authorization certificate
10.* Scanned application form signed and stamped with official seal.
3. The difference between license and filing is that license must have item 8: basic introduction and function description of computer information management system, computer management system.