Translation of Manufacturer's name in Chinese required on the label

As of 2019-01-01 the label of medical devices class II and III must include the manufacturer's name, address and product name translated into Chinese language.

The publication introducing the new requirements CFDA Order 43 2017 is only available in Chinese language.

The change in labelling needs to be reported towards the CFDA as a reportable change prior to 2018-12-21.