By submitting product data to health authority databases, the medical device industry can help ensure the safety and traceability of devices. One crucial element is the European Commission/EUDAMED-specific concept of Basic UDI-DI.
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Update on the EU EUDAMED Timeline On 6 July 2022, the European Commission (EC) updated the publicly posted timeline concerning EUDAMED development, audit and launch activities. This new timeline places milestones exactly 1 year later than previously published. What...
In China, key regulatory policies originate with the State Council (Executive Branch). At the policy level, regulations for medical devices started in 2016 with a five-year plan. For regulatory compliance, typically there is a registration process, clinical evaluation...