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Roadmap to Australian medical device market

Roadmap to Australian medical device marketThe current issue of Regulatory Focus [login required] contains interesting articles on regulatory pathways around the world.

"Regulation of Medical Devices in Australia and New Zealand", for instance, summarizing the state of affairs in Oceania. Since 2002, the fundamental principles underlying device assessments in Australia have been based on those developed for the European Union. The article does a nice job highlighting the similarities and differences.

If you are a RAPS member, take a look at Regulatory Focus. Otherwise, contact the authors (Judy Bingham and Philippe Robertson, both of Kendle) for more information.

ForeignExchange Translations provides specialized medical translation and software localization services to medical device companies. Contact us to learn more.


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