June 12, 2018

In accordance with the requirements set forth in the "Standards management of medical equipment" and the "Management standard for revision of medical equipment standard system," the CNDA has initiated the FY 2018 - The Revision Plan of the Medical Device Standards last May 15. There were 99 items of medical device industry standards listed in this plan. The list shall be revised by partner institutions within this year. Partner institutions include testing labs in each province in China.

A number of medical device giants have participated in this revision planning, such as Medtronic, Siemens, BSBE, Mindray, and United Imaging.

The listed standards shall be applicable to in vitro diagnostic reagents, non-active devices, implants, active devices, the Electromagnetic susceptibility (EMS) part of the electromagnetic compatibility (EMC), and unique device identification systems (UDI).

The revision plan shall cover a large scope. Manufacturers should keep themselves posted with any updates concerning the upcoming new standards.

Please see the further information on the official website