The following materials shall be submitted for the quasi-production registration of Class II and Class III medical devices produced by domestic enterprises:
1, qualification certificate of medical device manufacturer.
2. A copy of the trial production registration certificate.
3. Registered product standards.
4. Product improvement report during trial production.
5, enterprise quality system review (certification) valid documents.
6. The product registration type test report issued by the medical device quality testing institution recognized by the State Administration of Pharmaceutical Products in the past year.
7. Product quality tracking report.
8. Self-assurance statement on the authenticity of the submitted materials.
Class I and Class II medical devices shall be managed by the local provincial or municipal food and drug administration, and Class III medical devices shall be managed by the State Food and Drug Administration of the United States.
Extended data
Where national standards and industry standards are adopted as applicable standards for products, the texts of the adopted national standards and industry standards shall be submitted; The registered product standard shall be signed and sealed by the production enterprise. The production enterprise shall provide a statement that the product applied for conforms to the national standards and industry standards, a statement that the production enterprise assumes the quality responsibility after the product is listed, and a description of the product model and specification division.
Three types of medical equipment are used to support and maintain life; Medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled. Generally, it is approved by the State Food and Drug Administration of the United States and issued a registration certificate.
The word "quasi" is suitable for domestic medical devices; The word "gold" is applicable to imported medical devices; The word "Xu" is applicable to medical devices in Hongkong, Macau and Taiwan Province. ××××2 is the year of filing; ×××××× 3 is the serial number for filing.
Baidu Encyclopedia-Medical Device Registration Certificate