Medical Device Manual Requirements for the CFDA Registration

According to the CFDA regulations, all the imported medical devices that want to list in China have to do the CFDA medical device registration. In order to regulate the imported medical devices, CFDA keep updating their regulations. On July 30th 2014, China Food and Drug Administration (CFDA) issued the registration regulation about ‘Medical Device Manual and Label Management Regulation’.

The Main Contents of the Manual Should Include:

Product name, model and specification
Registrants or recording applicants’ name, home address, contact information and after-sales service firms. For the imported medical devices, it should state the legal representatives’ name, home address and contact information.
Manufactures’ name, home address, production address, contact information and production license number or production record voucher number. For the applicants who use the sub-contract production, they have to mark the sub-contract production companies’ name, home address, production address and production license number or production record voucher number.
Medical device registration certificate number or record number
Product technical requirement serial number
Product performance, main structure composition or composition, applicable scope
Contraindications, notices, warning and tips.
Installation and instructions or representations. If the medical devices are personally used by the customers, it shall have special instructions for safely use.
Product maintenance and maintenance methods, special storage, transportation conditions and methods.
Date of production, term of use or expiration date
List of accessories, including accessories, appendage, consumer goods replacement cycles and description of replacement methods.
The explanation of the medical device label’s graphics, symbols, abbreviations and other contents.
Manual compiled or revised date
Other contents that should be marked

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* If you have any comments or questions, please contact us at md@cirs-group.com.

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