SNB LAW CHINA: CFDA ANNOUNCES NEW MEDICAL DEVICE CLASSIFICATION CATALOGUE (EN)
On 31 August 2017, the China Food and Drug Administration (CFDA) announced a new Medical Device Classification Catalogue. The new Catalogue will be implemented on 1 August 2018 and replace the current Catalogue of 2002. Reasons for this amendment include that the current Catalogue is not detailed enough affecting a unified registration and approval procedure, and difficulties in covering new products and categories due to the lack of updates over time. The major changes that should be kept in mind by (medical) device companies operating in China are as follows.