Informational Medical Device Registration Process in Brazil - Anvisa (Part 3)

[Marcelo]

A topical glue or adhesive is like a bandage in use and does not enter the body (ie, not internal use).

Yeah, I know, but that?s why I said "probably". In the end It will depend on ANVISA?s interpretation and they can be very restrictive in their interpretations (meaning, a liquid that comes into direct contact with the organism as defined in IN 02 does not need to enter the body).

 

[tibon74]

Hi !

I heard that ANVISA will improve the inspection fees. Is it exact ?
if so, what will be the cost of this improvement?

thanks!!!

 

[Marcelo]

I heard that ANVISA will improve the inspection fees. Is it exact ?
if so, what will be the cost of this improvement?

I don?t know anything about it.

 

[Ctgio]

Hi all,

I am following this thread (and previous) since a long time and I have now a question. Thanks to all for your help or advice.

We are going to start the process of registration in Brazil (contrast media injectors). We have the EC certificate with BSI. I have then contacted them about the MDSAP (Medical Device Single Audit Program) and how it may ease / shorten the registration timeline or process. I am there especially talking about anvisa inspection. I have not yet received any answer from BSI.

Do you know if MDSAP is going to help? Do you have any idea how to best deal with Brazilian registration, anvisa inspection and MDSAP?

Thanks in advance

 

[Marcelo]

We are going to start the process of registration in Brazil (contrast media injectors). We have the EC certificate with BSI. I have then contacted them about the MDSAP (Medical Device Single Audit Program) and how it may ease / shorten the registration timeline or process. I am there especially talking about anvisa inspection. I have not yet received any answer from BSI.

Do you know if MDSAP is going to help? Do you have any idea how to best deal with Brazilian registration, anvisa inspection and MDSAP?

Hello, and welcome to the Cove.

The MDSAP program is still in pilot, which began this January - ANVISA is expecting to receive the initial reports from Canada in the beginning of the second semester of 2014. It will take some time (in my opinion, at least until next year) for it to be fully implemented and functional.

So I don?t think it will be useful to you now.

 

[DesiQE]

Even I was going to ask about the MDSAP. But this has been answered now.

Then another question is if you have a correlation matrix between ISO 13485 & RDC 16?

Thanks in advance.

 

[Marcelo]

Then another question is if you have a correlation matrix between ISO 13485 & RDC 16?

Nope, but you can use a matrix comparing ISO 13485 and 21 QSR 820 as a basis.

 

[Marcelo]

Another interesting information, ANVISA finally put an English version of RDC 16 in their website in the following link: https://portal.anvisa.gov.br/wps/content/Anvisa+Portal/Anvisa/Inicio/Produtos+para+Saude/Assunto+de+Interesse/Inspecoes+Internacionais/Inspecoes+Internacionais+de+produtos+para+saude

It?s RDC n? 16/2013 (INGL?S).

 

[DesiQE]

Thank you Marcelo. Appreciate it.

 

[bethlaiu]

currently we are having issues getting the audit report results from ANVISA. The BRH is having issues too. The most I've found has been your attachment nof the Cronograma de inspecoes inter5nacionais-CPROD/GIMEP. other than that there has not been movement other wise.What to do??