The foreign establishment engaged in Class Ⅱ&Ⅲ medical device shall apply for the registration to CFDA. The application materials shall contain following dossiers:
1. <Imported Class Ⅱ&Ⅲ Medical Device Registration Application Form> Download.
2. Supporting Documents for Imported Medical Device
- 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.
- Letter of authority of the China agent.
- Letter of commitment and business license of the China agent.
3. <List of Basic Requirements for Safety and Effectiveness of Medical Device> Download.
4. Summary
Include the overview, description of the product, model, packaging instruction, applicable scope, contraindication and other required information.
5. Research Information
Include the performance study, biocompatibility evaluation study, bio-security study, sterilization technical study, expiration date study, packaging study, preclinical animal experiment, software study and other required study material.
6. Manufacturing Information
State the overview of the manufacture procedure. For passive medical device, the manufacturing processing technique and the key technique shall be indicated; for active medical device, the description or flow diagrams of the manufacture procedure shall be indicated; for IVD reagents, the general manufacture technique shall be indicated, including solid phase carrier, color developing system, the collection and handling of samples, reaction condition, calibration method, etc.
7. 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. Click here for more clinical trial information.
8. 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.
9. Product Standard
Referring to below the <The Guideline on Preparation of Medical Device Product Standard>.
10. 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.
11. 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. For the contents involved in manual/label, please click here.
12. Declaration of Conformity
- State that the product meets the registration requirements of medical device.
- State that the product meets the Class Ⅱ&Ⅲ medical device catalogue.
- State that the product meets both the national standard and professional standard which is currently in effect.
- Sate that all submitted dossiers are authentic.
- 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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