Regulatory Requirements for for Class IIa Electro Medical Devices for South America

[Brain]

Can someone assist me with the regulatory requirements for Class IIa electro medical devices in South American Territories? I am specifically looking for the process to follow to register my device for sale in Bolivia (urgent), Chile, Brazil and Mexico. I have looked at websites and forums with no success> Please help?

 

[Marcelo]

Re: Regulatory Requirements for South America

Hello Brain and welcome to the Cove.

For your start, there are thread for registration and certification in Brazil here and here.

 

[Randy]

Re: Regulatory Requirements for South America

Technically Mexico is considered part of North America or sometimes Central America, but not South America.

In answer your best bet is to check specifically with each different country and through their agencies because what you are going to wind up with may or may not be totally accurate.

 

[sreenu927]

Re: Regulatory Requirements for for Class IIa Electro Medical Devices for South Ameri

Hi for Mexico requirements, see the below thread where you get the required documents.

http://elsmar.com/Forums/showthread.php?t=48234

Regards,
Sreenu

 

[sreenu927]

Re: Regulatory Requirements for for Class IIa Electro Medical Devices for South Ameri

Further, attached is a recent article from RAPs on medical device regulations in Latin AMerican Countries.

Hope this is useful!

Regards,
Sreenu