Loading...

News Center

Home / News

China: CFDA seeks feedback on unique identifiers for medical devices

2018/03/08

The rules released this week set out how CFDA intends to achieve this goal. CFDA is proposing to give companies some leeway to decide how to meet its broad objectives. The document allows for the use of one- and two-dimensional barcodes, plus optional radiofrequency tags, to identify the medical device. CFDA is encouraging the use of advanced technology but has left some decisions up to firms. CFDA shared guiding principles to help companies decide on how to adopt unique identifiers. These principles state that the identifier must be unique, relate to the medical device’s basic features and be compatible with regulatory requirements. The agency is accepting feedback on the draft until the end of April. More Information On RAPS

CFDA Notice (Chinese)