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.
Include the intended use, description of the product, explanation for bio-security, overview and evaluation of the main research consequence and other required information.
4. Research Information of Raw Materials
Include the reason why the main reaction component and calibrator are selected, their preparation and quality criteria; the test data for the fixed value of the calibrator.
5. Research Information of The Main Manufacturing Technique and Reaction System
The main manufacturing technique includes preparation, sub-packaging and freeze-drying of the operation fluid, packaging of the solid phase carrier, description and determination of the luminescent system; the reaction system includes the collection, requirement, dosage, reaction condition and calibrating method of samples.
6. Evaluation Information of Analysis Capability
The evaluation of analysis capability particularly includes the accuracy, sensitivity, specificity, linearity range and measurement range of the IVD product; the calibrator shall submit the traceable document and the quality controller shall submit the fixed value materials.
7. Determination Information of Positive Decided Value or Reference Interval
State the method/basis and used samples for determining the positive decided value or reference interval, and supply the test data and conclusion. Calibrator and quality controller is exempted for doing this.
8. Stability Study Information
Stability research is to study the stability of at least three samples in the time they are preserved to their expiration date, and take full consideration of disadvantages in the storage, transportation and use. The determination basis of the stability study, the specific research method and procedure shall be specified conspicuously.
9. Manufacturing and Self-inspection Record
Provide the continuous manufacturing and self-inspection record of three samples.
10. Clinical Evaluation Materials
Provide the clinical trial data, the intended use, the use condition, the applicable scope and the contraindication of the product. For imported medical device, the clinical trial data completed in the applicant’s original country shall be submitted as well. Calibrator and quality controller is exempted for doing clinical trial. Click here for more clinical trial information.
11. Security Risk Analysis Report
Include the intended use, determination of safety and hazard, risk estimate of the hazard, measures to control the risk and verification report, cite the inspection and evaluation report if necessary, etc.
12. Product Standard
13. Product Testing Report
Provide the product testing report and the pre-assessment for product standards given by qualified inspection institute. Click here for more product testing information.
14. Manual Instruction and Label
The manual instruction and label shall meet required labeling regulations, and for imported products, both the manual instruction and the label must be in Chinese version.
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.
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