Implementing UDI on medical devices in Shenzhen – benefiting healthcare regulation and delivery
There are increasing efforts to promote and implement the use of UDI for medical devices in China, but the scale involved is challenging.
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In Shenzhen alone, three separate regulatory departments are involved (Shenzhen Administration for Market Regulation, Shenzhen Health Commission and Healthcare Security Bureau of Shenzhen Municipality).
Adding to the complexity in that in Shenzhen city there is a total of 1,549 medical device manufacturers (14,095 medical device SKUs), 75,975 medical device distributors and 5,780 healthcare providers. This means the medical device supervision and traceability chain is long and challenging. Shenzhen Administration for Market Regulation has established one data platform for UDI, collected data from two sources (suppliers and healthcare providers), in a project led by three departments.
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