UDI Mandatory for Class III Medical Devices in China after June 1st, 2022!

Recently, NMPA issued an announcement on the implementation of the second batch of Unique Device Identification (UDI) of medical devices (Order 114 of 2021). From January 1, 2021, the first batch of 69 medical device varieties in 9 categories were required to have UDI. Regarding the second batch of UDI, detailed information can be found as below:

• Effective Time: June 1st, 2022
• Scope of Application: on the basis of the first batch, the remaining Class III medical devices (including in vitro diagnostic reagents) shall be included in the second batch of the UDI implementation.
• Note: after June 1st, 2022, when applying for the initial registration, renewal or change of registration, the applicant / registrant shall submit the device identifier of its minimum sales unit in the registration management system. Device identifier will not be reviewed as part of the registration dossiers, and the change of device identifier itself is not a change of registration.

The unique device identification is an “ID card” of medical devices, which is the basis for the unique and accurate identification of medical devices. It is involved in the production, distribution and use of medical devices, and helps to manage the whole life cycle of medical devices.

In October 2019, NMPA issued the Rules for Unique Identification System of Medical Devices, which requires all medical devices distributing in China to apply UDI gradually. At the same time, NMPA issued the Notice on the First Batch of Implementation of the Unique Device Identification. The Notice confirmed that 64 varieties of high-risk Class III medical devices, including pacemakers, hip prostheses and plastic injection fillers, shall be included in the first batch of medical devices with UDI.

As the Chinese government is encouraging the UDI application and implementation, this may be mandatory to your products as well. IMD provides UDI application services in China and we can help you evaluate whether you will be impact by this newly released UDI implementation list. If you have questions on China market, please contact us (info@inspirativemed.com) for more information.