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Future revision of ANVISA RDC 59 - Brazilian GMP

C

Calinours

#13
I am sorry but I am not a specialist of the South America regulations. This MERCOSUR resolution aims to standardizing the regulations in the economic space (i.e. only one regulatory system for MERCOSUR like EU mark)?

I have some other general questions at the level of South America:
- Is an EU marking or an approval FDA useful in South America?
- Does an approval in a South America country (Brazil for example) simplify steps for the recording in other bordering countries?

Thanks for all
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#14
Hello Calinours and welcome to the Cove!

I am sorry but I am not a specialist of the South America regulations. This MERCOSUR resolution aims to standardizing the regulations in the economic space (i.e. only one regulatory system for MERCOSUR like EU mark)?
Some regulations, such as the medical devices GMP regulations, are common for Mercosur countries. Yes, it´s something like what happens in the EU block

- Is an EU marking or an approval FDA useful in South America
It was in the past when countries had no individual regulations (some require CE marking, for example), but right now the majority of the countries have their own regulations and thus it´s not that useful from the standpoint of automatic compliance (but surely having CE or FDA means that probably you will already have the majority of the requirements covered).

- Does an approval in a South America country (Brazil for example) simplify steps for the recording in other bordering countries?
Nope.
 
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