Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

Brazil Trumps India with Device Makers?

Posted by crimsonlanguage on 2013/03/08

Blog_3-8Recently, it was reported by Devices & Diagnostics Letter (FDANews) that the Medical Imaging & Technology Alliance (MITA) had re-prioritized strategic discussions with Brazilian officials over Indian officials. The change, according to Zach Helzer, the group’s International Program Director, represented a change in MITA’s international business strategy as requested by member companies.

Appropriately, the actions of the Imaging Alliance bring visibility to a broader trend: given the changing regulatory and economic issues in India, including regulatory uncertainty (see “Clinical Trial Hold in India Leaves Devicemakers Unsure How to Proceed” in February, 2013, International Medical Device Regulatory Monitor) and economic slowdown (see WSJ,, Brazil may be pulling ahead of India in terms of overall attractiveness for device investment and market focus.

Considering Brazil GMP inspections may take 3-4 years and market access may take up to 6 years in total, saying India is less attractive from a regulatory perspective is really saying something. This is the reason that device makers are pushing ISO 13485 as a harmonized standard for access to all countries.

Crimson was the first translation company to register to ISO 13485 (and ISO 14971) – our certifications help you comply with this critical standard around the world.



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