Medical Device Labeling Requirements in China

According to the registration regulation about ‘Medical Device Manual and Label Management Regulation’ issued by China Food and Drug Administration (CFDA) on July 30th 2014, all the imported medical devices are required to provide the Chinese version labels.

The Main Contents of the Label 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.
Medical device registration certificate number or record number
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.
Date of production, term of use or expiration date
Power connection condition and input power.
Graphics, symbols and other relevant content that should be marked according to the product characteristics.
Required warning and notices.
Special storage, operation condition or explanation
If the medical device will destroy or have negative effect on the environment, the label should include warning symbols or Chinese warning explanation.
If the medical device with radiation, the label should include warning symbols or Chinese warning explanation. Due to the size or location limit of medical device label, it shall label product name, model, specification, date of production, term of use or expiration date. And it shall state on the label that the details will be included in the product manual.

CIRS Medical Device Manual and Label Compiling Service
If you have any questions about medical device label and manual compiling, please feel free to contact CIRS at md@cirs-group.com.

Related links:

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.