Medical Device Registration Process in Brazil - Anvisa (Part 1)

Re: Medical Device Registration Process in Brazil - Anvisa

ok, thank you for this information.
But, manufacturing steps in distributors are not critical.
Much of manufacturing is made in our factory.

Re: Medical Device Registration Process in Brazil - Anvisa

Dear sir,
I'd like to consult you about the process of chinese II medical products registrate in Brazil. What kind of documents it needs and what we should prepare, and how aboult the fee? Your early reply will be highly appreciated.
Best regards!

Re: Medical Device Registration Process in Brazil - Anvisa

Does anybody know if private labs who offer testing services to e.g. hospotals are allowed to use Research use only IVDs in their service?
Are they allowed to validate an assay that is not yet apporved, and offer the results for patient management?

The labs say they can, but the authorities may feel differently and I do not want to compromize the future registration of the product...
Camilla

Re: Medical Device Registration Process in Brazil - Anvisa

I work for a Brazilian company that is developing the product specifications for a medical device. We are using a toll manufacturer in Brazil to manufacture the product and also distribute the product in Brazil--this company will be the registration holder.

My question is whether the name of the registration holder needs to appear on the packaging? We would like to use our company's name, logo, address, etc. but I am unsure of the requirements for identifying the registration holder.

Thanks for your help.

Re: Medical Device Registration Process in Brazil - Anvisa

Hello,

My name is Nikolas. I am a student for biomedical engineering and I am actually doing some hands on experience at company for endoprosthetics in northern Germany.
We like to sell our products to Brazil in the future and one of my projects is to prepare the company for the ANVISA Audit in the best way.
Do you guys have any advices for me?
I had read, that the Brazilian RDC is similar, nearly equal, to the European MD directions, but i also read that the RDC got a couple of specifications.
Thank you for your help.

Re: Medical device registration process in Brazil - Anvisa

Hi ,

Can someone please post the " manual for regulation of medical device in Brazil" in ENGLISH ..my google translator is just acting wierd only few pages are getting translated the rest are in portugese. Can someone kindly help please....

Thanks In advance
Rk

Re: Medical device registration process in Brazil - Anvisa

ramkannan13 said:

Hi ,

Can someone please post the " manual for regulation of medical device in Brazil" in ENGLISH ..my google translator is just acting wierd only few pages are getting translated the rest are in portugese. Can someone kindly help please....

Thanks In advance
Rk

Click to expand...

Google translate seems to have a limited capacity so you have to translate in batches of e.g. 10 pages. Tiresome but managable.

Sorry not to be of more help.
Camilla

Re: Medical device registration process in Brazil - Anvisa

Rocke said:

Google translate seems to have a limited capacity so you have to translate in batches of e.g. 10 pages. Tiresome but managable.

Sorry not to be of more help.
Camilla

Click to expand...

Thanks Camilla, your Reply was quite helpful..atleast now I know that I can do 10 pages then the rest.

Much appreciated!
Cheers,
Rk

Re: Medical device registration process in Brazil - Anvisa

With the help of Google translate, the English Version of the Guidance doc for Medical device - Brazil.


Please re-arrange for spacing and editing . Hope it helps ....
Rk

Re: Medical device registration process in Brazil - Anvisa

ramkannan13 said:

With the help of Google translate, the English Version of the Guidance doc for Medical device - Brazil.

Please re-arrange for spacing and editing . Hope it helps ....
Rk

Click to expand...

Thanks Rk.

Word of caution .... the translation is for information alone and can not be held valid.