In vitro diagnostic (IVD) reagents pertaining to medical device are defined as reagents, instruments, calibrators and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, an observation of after-cured situation, in order to predicate or prevent disease. Such products can be used individually or used in combination with other instruments, facilities or systems. It must be pointed out those IVD reagents those adopt radionuclide label or intended for use in blood kinship screening, such products pertaining to drugs instead of medical device administration and are not included here.
For Class Ⅰ IVD products, you shall implement the record keeping as Class Ⅰ medical device; and for Class Ⅱ&Ⅲ IVD products, you shall implement the registration. Either the record keeping or the registration is in the charge of CFDA.
Typically, there is no large difference between the required registration dossiers for IVD products with those for general medical device. And the required registration dossiers for general medical device particularly lay emphasis on the safety and effectiveness of the products toward people body (such as biocompatibility test report and electromagnetic compatibility test report), while those dossiers for IVD product shall pay more emphasis on the methodology study (such as reaction system and analysis capability), and the IVD product testing focus on the accuracy, repeatability and stability of the diagnostic principle.
The foreign establishment engaged in Class Ⅱ&Ⅲ IVD products shall apply for the registration to CFDA. The application materials shall contain following dossiers:
1. Application Form
2. Supporting Documents
1) The market approval released by applicant’s national government, which is a legal proof/certificate/license demonstrates that the product is approved to be sold as a medical device in the market of the applicant’s country.
2) Letter of authority of the China agent.
3) Letter of commitment and business license of the China agent.
4. Research Information of Raw Materials
5. Research Information of The Main Manufacturing Technique and Reaction System
6. Evaluation Information of Analysis Capability
7. Determination Information of Positive Decided Value or Reference Interval
8. Stability Study Information
9. Manufacturing and Self-inspection Record
10. Clinical Evaluation Materials
11. Security Risk Analysis Report
12. Product Standard
13. Product Testing Report
14. Manual Instruction and Label
15. Declaration of Conformity
1) State that the product meets the registration requirements of medical device.
2) State that the product meets the Class Ⅱ&Ⅲ medical device catalogue.
3) State that the product meets both the national standard and professional standard which is currently in effect.
4) Sate that all submitted dossiers are authentic.
5) For domestic product, the applicant must sign the declaration; and for imported product, both the foreign applicant and China agent must sign the declaration.