NMPA issued a notice today to delay the UDI implementation date. The first batch of medical devices have changed from October 1st, 2020 to January 1st, 2021. The notice adjusted both the timeline and scope of new medical devices as detailed below:
- Five more types of high-risk class 3 implantable devices have been added to the first batch of devices for UDI implementation. Additionally, NMPA encourages more companies to voluntarily participate in Phase 1 of the UDI implementation. This will especially focus on products from ‘the first batch of national high-value medical consumables list.’
- In order to minimize the impact of Covid 19 on the UDI implementation, the pilot phase will be extended to December 31, 2020, and the compliance deadline for the first batch of devices has been changed from October 1, 2020 to January 1, 2021.
More Information on UDI Implementation
Please visit link for more information on NMPA UDI rules and China Med Device comments. China Med Device offers UDI turnkey solutions. We have experience in helping overseas manufacturers’ to successfully go through the entire UDI process in China.
Since we have many resources with offices in Boston and Beijing as well as a thorough understanding of China UDI rules, we could best help companies to leverage what they’ve already in place from their US/EU UDI portals. Please email info@ChinaMedDevice.com if you would like to set up a call to discuss your needs.