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White Paper
Medical Devices Regulations

Medical Device Regulations in the Main Global Markets

This document summarizes the main aspects of the medical device regulations that currently apply to the 13 main global markets (Australia, Brazil, Canada, China, Egypt, Europe, Hong Kong, Japan, Korea, Saudi Arabia, Singapore, Taiwan, USA). It gives an indication of the main requirements, approvals and registrations needed by the manufacturer before devices can be legally sold in those markets.

The current edition contains the new regulations for Notified Bodies published by the European Commission at the end of September.

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