China Hopes To Implement Unique Device Identifier System By Year End
This article was originally published in The Gray Sheet
Executive Summary
China has been talking about implementing a UDI system to track distribution of medical devices for years. Former CFDA and U.S. FDA experts now suggest that China plans to implement such as system by year end.
You may also be interested in...
China Shows More Of An Open Door To Overseas Medtech Industry
China's influence on global medtech regulation and the country's continuing emergence on the world stage will be felt increasingly in the coming years. But while China may be less inclined to exclude big medtech multinationals, it feels no compulsion to harmonize totally with the US and/or EU systems.
Questions Remain On Incorporating UDIs Into Health Care System
As part of implementation of unique device identifier requirements, hospitals will need to capture the unique codes in electronic health records and claims forms, but the logistics of doing so are still being worked out.
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.