China Fully Implements UDI Requirements for Class III Medical Devices

Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories. In accordance with NMPA Notice No.114, 2021, all remaining Class Ⅲ medical devices (including IVDs) are subject to UDI implementation from June 1, 2022.

All the class Ⅲ medical devices registrants shall take actions to meet the following requirements:

1. From June 1st, 2022, all the newly produced medical devices should have UDI.
2. From June 1st, 2022, when applying for initial registration, registration renewal or registration change, the registrants shall submit the product UDI of its minimum sales unit.
3. From June 1, 2022, before marketing, for the newly produced medical devices, registrants shall upload the UDI data related to the products to the unique identification database of medical devices and ensure that the data are true, accurate, complete and traceable.

What is UDI?

UDI is an international system for identifying Medical Devices (MDs) meant to help quickly identify people affected by product recalls, device failures, or serious adverse events. UDI has been adopted by the International Medical Device Regulators Forum (IMDRF) to help harmonize global implementations and is in different stages of implementation around the world. UDI consists of a bar code and a numerical or alphanumerical system that quickly identifies the Device model, the Production information (batch/lot, software version, etc.), and Data delimiters.

For more information on UDI in Singapore, please see our blog on the topic here.