Registrar/certification bodies for Brazil market.

Good morning,

We are a french company and we are ISO 13485, ISO 9001 certified for design, manufacturing, sales and servicing support for neuro muscular electro stimulator. Today we market only one product which is a class IIa medical device (according European directive).
We would like to start business with Brazilian company for distribution of the product. In order to get ahead of the registration, we are looking for a registrar/certification body which could issue a ISO 13485 or 9001 certificate recognized or accepted by ANVISA. It could allow us reduce the delay of registration. In fact, our notified body is not accredited for Brazil but it ask for the list of certification bodies recognized in Brazil. I searched on ANVISA website, INMETRO or certification bodies website but its difficult to find it. Does somebody know European certification bodies which can make such service (Except TUV)?

Thanks in advance for helping,
BR

Hello, and welcome to the Cove.

Anvisa don´t accept ISO 9001 or ISO 13485, you need a brazilian GMP certificate which is only issued by Anvisa.

More on this can be read at the following threads:

- Medical Device Registration Process in Brazil - Anvisa

- Factory Inspection to Register and Certify a Medical Device in Brazil

If your product is a medical electrical equipment, then you need to get thru a certification process to get a certification certificate, and in this case you need to use a certification body. This certification process is responsibility of Inmetro, but it´s a difficult to find the information on the Inmetro website.

And old list can be found here :http://www.abimed.org.br/associados/ocp.pdf

It´s a little outdated on people and maybe phones, but the certifications bodies are these (there´s a new one i thik, but i do not remember which one).

Links corrected.