T
The CFDA recently issued 104 medical device industry standards (which include 31 mandatory standards and 73 recommended standards) and 2 revised medical device industrial standards. It is said to be the first time the CFDA promulgated medical device standards since its establishment. Also for the first time, the announcement specifies the scope of the standards. This recent issuance brings the number of China?s medical device standards to 1166 which includes 201 national standards (the GB standards) and 965 industrial standards (the YY standards).