China NMPA delayed UDI implementation date to Jan 1st, 2021
After I answered the UDI locked fields yesterday, right before China 10 day national holiday, NMPA issued a notice today to delay the UDI implementation date for the first batch of the piloted medical devices from October 1st, 2020 to January 1st, 2021. The notice adjusted both the UDI implementation timeline and scope as detailed below:
- 5 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 the phase 1 UDI implementation, especially 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.
There have been a listing of the related regulations and content in the reply on the UDI locked field. We have implemented UDI for implanted devices already in China. I would love to hear your UDI implementation experience.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------