China YY Standards, also known as industry standards, are formulated as technical requirements for medical devices in China. YY Standards are issued by the National Medical Products Administration (NMPA). “YY” is the code for mandatory industry standards, while voluntary industry standards have the “YY/T”.
On April 28, 2022, the NMPA announced (No.47-2022) the latest implementation and amendment plan for YY and YY/T industry standards in China.
New China YY Industry Standards for Medical Devices
The NMPA announced a list of 59 new YY/T standards to be implemented which cover 2 standards related to Artificial Intelligence (AI) medical devices, 7 standards related to In-Vitro Diagnostics, and 10 standards related to implantable medical devices.
China YY and YY/T Standards Amendments for 2022
In addition, the NMPA announced a list of 57 existing industry standards, consisting of 23 YY standards and 34 YY/T standards, to be amended:
- Amongst the 23 YY standards, there are 6 standards related to medical device implants that will be amended.
- Amongst the 34 YY/T standards, there are 2 IVD related standards and 4 medical device implant related standards that will be amended.
According to the announcement, the NMPA list the institutes responsible for carrying out the respective projects for new standard implementation or the amendment of existing standards. However, the projects are still at an early stage of development. The schedule for the finalization of projects is expected to be released on a later date.
Read our previous blog post covering a brief report and analysis on the total number of Chinese medical device standards, including national (GB and GB/T) and industry (YY and YY/T) standards, recorded in 2021.
Interested to know if your product will be affected by this regulatory update? Want to better prepared for the new industry standards? Please send your enquiry to Cisema.
As China regulatory and registrations specialists, Cisema can assist you with the modification of your Quality Management System to meet Chinese standards.
By Julie Zhang and Jacky Li.