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Can Brazil approval be used for other countries in Latin America?

#1
If a device approved in Brazil wants to sell in Peru or Colombia... what can be reused? What must be done from scratch? What are the main differences / similarities?

What is the situation with Mexico (North America). Do the accept brazil or fda? Ce mark?
 

Marcelo

Inactive Registered Visitor
#2
No, in fact nowadays there's only a few countries where approval in another country can be used, and generally, they provide a which pathway, not a direct "approval".

Each country has its own sent of specific regulatory requirements which must be identified and compiled with.
 
#3
Probably some of the information can be reused and some will have to be developed from scratch. What can be reused, what must be developed from scratch, the differences and similarities in the requirements of one country versus another, these will typically be specific to each device.
 
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