BRAZIL: Regulatory requirements regarding aids for invalids

[EB MD24]

Good morning,
I am looking for information on the Brazilian regulatory requirements regarding aids for invalids (e.g. wheelchairs, crutches, hearing aids).

Do You have any information on these particular requirements?

If not, can You give me a telephone number and/or an e-mail address of someone working at the ANVISA medical device department who can speak English?

If possibile, can You reply as soon as possible? I need to have this information by tomorrow morning (10 AM CET).

Thank You.

 

[RoxaneB]

I did a search for "Brasil mobility aids regulatory requirements" and THIS was located for me. Hopefully something in that search will be of use.

 

[Ted Schmitt]

Marcelo Antunes is here on the forum and probably your best bet for this info...

 

[Marcelo]

The requirements for those medical devices are the same as of the general medical devices.

A particular requirement that is not in force right now (because Brazil does not have test houses to test to the applicable standards) for wheelchairs and hearing aids is the need for an INMETRO certificate.