Chinese regulators delay medical device UDI implementation

China’s National Medical Products Administration (NMPA) has 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 (link in Chinese) 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.

Expanded list of first-batch devices subject to NMPA UDI requirements

The first batch of medical devices identified by NMPA for UDI requirements comprised Class III high-risk devices. In its announcement on the UDI implementation delay, 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.

Manufacturers and Agents may still enroll in the UDI pilot between now and the January 2021 deadline, according to NMPA.

Related Chinese medical device regulatory information from Emergo by UL:

• China NMPA medical device registration and approval consulting
• China NMPA medical device clinical and testing requirements consulting
• Whitepaper: China NMPA medical device registration requirements