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- Operating in a global environment means following many different standards
- This is especially true in the health industry – improper procedures or policies could lead to huge penalties for a company that breaches them
- Cochlear’s adherence to foreign regulations is critical – over 95% of their revenue comes from non-Australian markets
- They hinder Cochlear’s global competitiveness – local competitors are only concerned with their own market-
- In 2014, the Australian Govt announced it would allow medical device manufacturers to use EU certification in place of TGA certification, significantly shortening the time for getting a product to market