The foreign enterprise engaged in Class Ⅰ medical device, including Class Ⅰ in vitro diagnostic (IVD) reagents shall apply for the record keeping to CFDA. The application materials shall contain following dossiers:
1. <Imported Class Ⅰ Medical Device Record Keeping Application Form> Download.
2. 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.
3. Technical Requirements (Product Standard)
Referring to below the <The Guideline on Preparation of Medical Device Product Standard>.
4. 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.
5. Clinical Evaluation Documents
Specify conspicuously the intended use, the use condition, the applicable scope and the contraindication of the product. Click here for more clinical trial information.
6. 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.
7. 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.
8. Supporting Documents for Imported Medical Device
(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.
9. Declaration of Conformity
(1). State that the product meets the record keeping requirements of medical device.
(2). State that the product meets the Class Ⅰ medical device catalogue or Class Ⅰ IVD reagents.
(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.