Responsibility for Medical Device Classification Reallocated

New regulations relating to the classification of medical devices have been issued by the General Office of the China Food and Drug Administration (CFDA). Once these new guidelines come into effect, as of 1 August 2018, provincial food and drug administration bodies will be responsible for processing all medical device product classification applications submitted by applicants within their administrative regions. It will also be their responsibility to subsequently determine the relevant product classification or to give their opinion as to the relevant pre-classification determination after taking all of the requisite factors into account.

The CFDA’s Center for Medical Device Evaluation will be responsible for handling applications relating to the classification of devices imported from abroad, as well as from Hong Kong, Macau and Taiwan. It will also fall to the Center to review any product classification determinations based on the pre-classification opinions of the relevant provincial food and drug administration bodies.

For further details (in Chinese), please refer to the following link:

Circular of CFDA (Shi Yao Jian Ban Xie Guan No. 127 [2017])