The Chinese Food and Drug Administration (CFDA) released the draft of a new Regulation that will be effective as of January 2018.
According to this Regulation, foreign Medical Devices manufacturers intending to register their products in China shall provide Simplified Chinese business information and contact details.
The new Regulation adjustment timeframes are set by December 31, 2018 for all medical device manufacturers who already obtained a CFDA registration certificate.
The public consultation phase has just ended and we are looking forward to the Authority official publication.
For more information: http://www.sda.gov.cn/WS01/CL0779/175821.html