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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.
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 and regulatory submission requirements.