ack in September 2020, NMPA made an announcement on “Deepening the Pilot Program and Implementing the First Batch of Unique Identification of Medical Devices”. Now, this has been fully implemented starting January 1, 2021. Earlier, the NMPA had extended the trial period for its medical device unique device identification (UDI) program in response to the coronavirus pandemic, pushing first-round UDI implementation requirement deadlines to early 2021. The NMPA announced that the impact of the COVID-19 public health emergency in China has necessitated pushing back the regulator’s UDI trial period ending date from October 1, 2020 to January 1 2021.

Now the trial period is over and the full implementation is in place from Jan 1, 2021. The first batch of medical devices identified by NMPA for UDI requirements comprised Class III high-risk devices. Furthermore, in NMPA’s postponement announcement on the UDI implementation, the regulator has also added device types including in-ear prostheses and spinal interbody fixation/replacement systems to the list of products that must be UDI-compliant by January 2021.

According to this, for medical devices listed in the "Catalogue of the First Batch of Product Implementation the UDI", when the applicants or registrants submit application form for registration, renewal or registration change of medical device product in the electronic regulated product submission (eRPS) system, they should fill in and upload UDI-ID related information according to the template provided on the page.

Secondly, if UDI-DI information is not filled in the application form in accordance with the above requirements, the application form cannot be submitted and the registration declaration information shall not be signed and received.

For general information, UDI-DI is not subject to registration review matters and is created by the applicant or registrant in accordance with the Rules of the Unique Identification System for Medical Devices. Besides, the submission requirements for other annexes to the application form remain unchanged.



Announcement on the submission of the unique identification of medical devices in the eRPS system (No. 26 of 2020)