NMPA (CFDA) issued the First Group of Unique Device Identification Devices (Draft) for feedback on September 17, and specified the medical devices going into UDI implementation.
In early July, NMPA UDI Implementation Plan stated that “high risk implanted devices, such as cardiac implants, brain implants and prosthesis, are included in the first trial”. At this time, the First Group elaborated the Plan, and listed 64 Class III medical devices including:
At the same time, the document specifies the timelines for implementing UDI system for the first group of devices:
For English version of UDI rules NMPA published on August 27, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
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