Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

World Cup AND Medical Device Regulatory Action Out of Brazil

Posted by crimsonlanguage on 2014/06/28

 

Neymar Flop

          Could it really hurt that badly?

How often will you see those two items in a single headline? I’m just pleased to have a credible excuse to share this hilarious story that appeared in the WSJ on the “World Cup of Flopping” – ranking national teams by their on-field “writhing time”. Not surprisingly, Brazil topped the list, but Chile was a close second. We’ll see who “out-flops” the other in today’s 12:00 match: exciting stuff.

However, very shortly, it just might be U.S. medical device manufacturers who are clocking writhing time in Brazil. Word from a recent Class III client regarding unexpected  ANVISA scrutiny in their registration process is definitely something to cry about: including no longer accepting Portuguese for Portugal (vs. Brazil) in labeling. Ouch!

The written forms of these two languages are mutually intelligible – a Brazilian can read in Portugal and vice versa – but there are significant spelling and grammar differences – and now, evidently, this has become a point of regulatory enforcement for ANVISA…and manufacturers selling into Brazil.

If you have direct experience of tightening ANVISA requirements, post and comment and let us know! – thanks.

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