Second, the specific process:
(1) First, apply for a business license in the Industrial and Commercial Bureau and register as an enterprise, which can be a legal person enterprise, an unincorporated enterprise, a sole proprietorship enterprise, a partnership enterprise, etc. Individual industrial and commercial households may not apply for filing vouchers.
(2) Then go to the Quality Supervision Bureau for the organization code certificate.
(3) Finally, register an account with an organization code on the website of the State Food and Drug Administration of the United States, and make an online declaration.
(4) Electronic materials to be submitted for online medical device filing, in which * is required.
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.
Three, the second class of medical devices for the record, the examination and approval department for the municipal food and drug administration. After the online declaration is accepted, the enterprise provides paper materials to the government affairs hall as required. After the on-site acceptance is qualified, it can operate with a filing certificate.