1, the enterprise should be based on the "Medical Device Classification Rules" and "Medical Device Classification Catalog" to fill out the "application for registration of medical devices product category of self-determination table.
2, the second and third class of medical device manufacturers to obtain the provincial Food and Drug Administration "Medical Device Manufacturer License", the first class of medical device manufacturers have obtained the first class of medical device manufacturer registration form, and apply for registration of the product should be in the approved scope of production.
3, declared registered products should have applicable product standards, you can use national standards, industry standards or develop registered product standards, but the registered product standards shall not be lower than the national standards or industry standards, the enterprise to develop registered product standards should be in line with the "Measures for the Administration of Medical Devices Standards", "on the issuance of the standard for the preparation of medical device registered product standards notice" related requirements.
Two, application materials
(a) apply for the first registration of the information to be submitted (in duplicate):
1, Zhoushan City, Class I medical device product registration application form (stamped);
2, medical device manufacturer's license or a copy of the registration form of the first class of medical device manufacturers (stamped);
3, industrial and commercial A copy of business license (seal);
4, apply for medical device product registration category self-determination form (seal);
5, for the first class of medical devices registration application affairs should be entrusted by the manufacturer, with a legal person authorized to delegate and a copy of the personal identity card (seal);
6, the applicable product standards and descriptions:
(1) the use of national standards, industry standards as a basis for the registration of medical devices;
( (1) the use of national standards, industry standards as the applicable standards of the product, should be submitted to the adopted national standards, industry standards and the effective text of the adopted standards and instructions for the adoption of the standard;
(2) the use of registered product standards as product standards, should be submitted to the official text of the registered product standards and their compilation instructions, and stamped by the producer or its legal representative, the person in charge of signatures plus the corporate seal.
(3) the application of the product in line with national standards, industry standards, the statement of the manufacturer to assume responsibility for the quality of the product on the market, as well as the relevant product model, specification division of the statement.