The third class of medical devices is required to apply for registration.
Domestic enterprises to produce the second class, the third class of medical devices quasi-production registration should be submitted as follows:
1, medical device manufacturer qualification certificate.
2, a copy of the trial production registration certificate.
3, registered product standards.
4, product improvement report during trial production.
5, enterprise quality system assessment (certification) of the effective documents.
6, the State Drug Administration recognized medical device quality testing organizations within the past year issued by the product type test report for production registration.
7, product quality tracking report.
8, the authenticity of the materials submitted to the self-assurance statement.
The territory of the first and second class medical devices in the local provincial or municipal Food and Drug Administration for the third class to the State Food and Drug Administration for.
Extended Information
Adoption of national standards, industry standards as the applicable standards of the product, should be submitted to the adopted national standards, industry standards of the text; registered product standards should be signed by the manufacturer. Production enterprises should provide the application of the product in line with national standards, industry standards, the statement of the production enterprises to assume responsibility for the quality of the product on the market, as well as the relevant product model, specification division of the description.
Class III medical devices are used to support, maintain life; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Generally by the State Food and Drug Administration to approve, issue a registration certificate.
"Permit" word applies to the domestic medical devices; "into" word applies to imported medical devices; "permit" word applies to Hong Kong, Macao, Taiwan medical devices; ××××2 is the filing year; ××××3 is the filing number.
Baidu Encyclopedia - Medical Device Registration Certificate