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

On July 19, 2021, NMPA issued the Notice on the Second Batch of Implementation of the Unique Device Identification (Draft) for public comments. Any feedback needs to be submitted by  August 16, 2021.

In order to further implement the Regulations on the Supervision and Administration of Medical Devices and the relevant notice released by the State Council, the Second Batch of Implementation of the Unique Device Identification (Draft) has been issued.

Implementation Time: after March 1, 2022, Class III medical devices shall have UDI.

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 March 1, 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 (UDI) 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 at info@inspirativemed.com for more information.