China Medical Device Label and Manual Requirements

On July 30th 2014, China Food and Drug Administration (CFDA) issued the registration regulation about ‘Medical Device Manual and Label Management Regulation’. All the medical device that market in China should compile the manual and label corresponding to this regulation.

Definition

Medical Device Manual---The technical document compiled by the product registrant or filer for providing the basic safety information of product installation, debugging, operation and maintenance to the users.
Medical Device Label---Labels are the words descriptions and graphic symbols on the medical device or packaging for identifying product features and indicate safety warnings.

The Main Requirements for the Medical Device Manual and Label Compiling

Product manual and label shall be scientific, realistic, complete, accurate and consistent with the product features.
Product manual and label shall be consistent with the filing or registration contents.
Product label shall be conformed to the content in the product manual.
Product label contents from the manual, so it shall not exceed the range of the product manual.
Product manual and label shall use the unification issued or normative terminologies and national standard units for the description of the diagnosis and disease name.
The main content requirements for the product manual and label
What kind of content that product manual and label shall not include

CFDA Post-marketing Supervision-- Medical Device Quality Sampling
According to the CFDA Announcement about Strengthening the Medical Device Sampling Work, CFDA keep strengthening their supervision on the medical device. And medical device label and manual compiling is still a challenge for the manufactures.
Sample. (Click here to see the detailed statistic about CFDA medical device quality sampling.)

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.
Label sample:

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.