CFDA to renew 'Rules for Classification of Clinical Laboratory Medical Devices'

The Rules for Classification of Medical Devices, adopted at the executive meeting of China Food and Drug Administration on June 3, 2015, was effective as of January 1, 2016.

'Table for Determination of Medical Device Classification' issued by China CFDA can be downloaded from this link. (PDF, 264KB)


Resources say that CFDA is now trying to revew the 'Rules for Classification of Clinical Laboratory Medical Devices'. It is believed that there will be significant changes in the modification of the rules, including classification of Class I and Class II devices, description to product, intended usage of product, product naming rules and etc. In the to-be-published new Rules, there will be 22 categories instead of 43 categories in the old version.

The new Rules will probably be published within 2016.