Module 16 2024

17/10/2024

Unique Device Identification

• Unique Device Identification – Current & Developing Legislation

• US/China/Egypt/Hong Kong/South Korea/Saudi Arabia/Taiwan – already in place • EU – from 2021 – 2025 depending on risk Class • Brazil – 2020 for high risk devices • ANZ – in line with EU • UK, Japan, India, Singapore, Canada and Switzerland all tbc.

The Organisation for Professionals in Regulatory Affairs

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Unique Device Identification (UDI) – Why UDI?

• Need to improve traceability in the Healthcare Supply Chain

• UDI is an enabler – McKinsey Report (October 2012) highlighted the patient safety benefits and cost savings from adopting a single global supply chain standard in healthcare.

• Could save 22,000 – 43,000 lives

• Could avert 0.7 million to 1.4 million patient disabilities

• Cost savings of $40 - $100 billion globally

The Organisation for Professionals in Regulatory Affairs

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