A, the operation of Class II medical devices do not need to apply for a business license, only need to apply for the filing of certificates can be.
Two, for the specific process:
(a), first of all, to the Business and Industry Bureau for a business license, registered as an enterprise, can be a legal person enterprise, unincorporated enterprises, sole proprietorships, partnerships, etc., individual businessmen can not apply for the filing of vouchers.
(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 a copy of the organization code certificate
2. legal representative, the person in charge of the enterprise, the person in charge of quality of the identity, education or title certificate copy
3. organizational structure and departmental setup description
4. scope of business, the mode of operation description
5. place of business, warehouse address of the Geographic location 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, working procedures and other documents
8. computer information management system basic information and functional description
9. manager's authorization certificate
10. p>
10. signed and stamped scanned version of the application form
Three, the second class of medical devices for the record, the approval department is the municipal level of the Drug Administration, the online declaration of acceptance of the enterprise according to the requirements of the paper materials to the hall of government to declare the acceptance of the site, the issuance of the record voucher you can operate # Class II medical devices for