How to Record/Register Your Medical Devices

General Information
To guarantee the safety and effectiveness of medical devices, any foreign enterprise engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the China and wants to record or register their products in China, must conduct the record keeping or registration in accordance with the <Regulations for the Supervision and Administration of Medical Device> issued by CFDA.
The “market approval” released by your national government is necessary for the imported medical device, which is a legal proof/certificate/license demonstrates that your product is approved to be sold as a medical device in the market of your country.
For Class Ⅰ medical device, you shall implement the record keeping; while for Class Ⅱ&Ⅲ medical device, you shall implement the registration. Either the record keeping or the registration is in the charge of CFDA.
The general required preparation dossiers would include security risk evaluation report, product standard (technical requirement), product testing, clinical evaluation report, manual and label, quality management system, etc. You can see below to find detailed preparation dossiers for record/registration procedure.

Record/ Registration Procedure

For more procedure details, please click here.
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