Over the past 15 years, I have been fortunate enough to travel around the globe discussing and developing Unique Device Identification (UDI). I am always struck by how similar – and yet interestingly different – people, societies, and countries (as well as the regulation of medical devices) are around the world. Nowhere is this truer than in China. Though the people of China are similar in many ways, there is so much that is different. There are differences in the language (both written and spoken), the food, the culture, the politics, and the “eastern” toilets (enough said). And at least for those of us from the east coast of the US – I find it very interesting that the hour is the same – just half a day ahead…at least I don’t have to change my watch!
I am reflecting on these similarities and differences as some of us were in Hangzhou, China, for the 8th China International Medical Device Regulatory (CIMDR) Forum two weeks ago. The key question that we have been wrestling with – for over 8 years now – is how “similar” (if at all?) will the China Food and Drug Administration (CFDA) UDI scheme be to the US and EU regulations? And, when does something that is similar, yet different, become so different that it can no longer be considered the same or similar?
As previous posts have discussed – the goal of the Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF) UDI guidance documents are to provide a common regulatory framework to follow – such that a “globally harmonized approach” (whatever that really means?) to UDI would be realized. As we have already seen with the EU MDR/IVDR UDI regulations – “globally harmonized” does not mean “the same.” There are critical differences between the US and EU UDI regulations – even though they are both based on the same (global) guidance documents.
At least from what we could discern from the presentations and conversations at the Forum, we are likely some time away from seeing a UDI proposal from CFDA. They continue to work on device nomenclature/classification and seem to want to focus their UDI activities initially (at least for now) on implants. (More to come on this as it becomes available.) For me, these similarities and differences beg larger questions – can (should?) companies continue to strive to produce a single labeled/packaged device for global distribution? When are there enough differences (e.g., languages, “UDIs”) that a country/region-specific label is warranted? I know our collective goal has been a single global UDI – but I am wondering if this is going to be sustainable moving forward…
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About the Author
Jay Crowley is the Vice President of the UDI Services and Solutions at USDM Life Sciences. Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s Unique Device Identification system.
About USDM Life Sciences
USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.