I, the operation of the second class of medical devices do not need to apply for a business license, only need to apply for the record certificate can be.
Two, for the specific process:
(a), first to the Industrial and Commercial Bureau for a business license, registered as an enterprise, can be a corporate enterprise, unincorporated business, sole proprietorships, partnerships, etc., individual businessmen and women are not allowed to apply for a certificate of record.
(ii), and then to the Quality Supervision Bureau for the organization code certificate.
(c), and finally to the State Food and Drug Administration website with the organization code to register an account, online reporting.
(d), online filing of "medical device filing application form" need to submit electronic materials, which add * for the necessary items.
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 identification, education or title certificate copy
3. * organization and department set description
4. * business scope, business mode description
5. * business premises, warehouse 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
three, the second class of medical devices for the record, the approval of the department is the municipal level of the Drug Administration, the online declaration of acceptance of the enterprise according to the requirements of the paper material to the Hall of Government to declare the acceptance of the site, after the issuance of the record voucher, you can operate.