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

[Marcelo]

I know that we can submit protocol for a product registration only with an ANVISA inspection request. So a B-GMP is not more needed for a protocol submission.
However, could we submit a protocol for a product registration with a "MDSAP inspection request" requested to a Canadian Registrar (organism recognized by health canada) ?

Good question! The option to submit with the ANVISA inspection request is the only clear option. There?s no formal option right now in the case of using the alternative MDSAP route. So you cannot do it now. I?m not sure if ANVISA intends to change to include this option, for example, including the option in a revision of RDC 15. I will ask them when I have the change, but this may take time.

 

[tibon74]

ok! thank you !
how much time does it take to have a B-GMP certificate using a MDSAP inspection report ?

 

[Marcelo]

how much time does it take to have a B-GMP certificate using a MDSAP inspection report ?

Shouldn?t take much, however, as I mentioned previously, ANVISA did not receive any report yet, so when they do, it will probably take more time in the initial ones.

 

[tibon74]

Hi Marcelo,

I have a really complicated question and I hope find a response .
If a company "X" buy a company "Y" and following this event, products from company "Y" are sold to a company "Z". Is it possible to change in the Brazilian regsitration license the legal manufacturer from
company "Y" to company "Z" ?
Thank you !

 

[Marcelo]

If a company "X" buy a company "Y" and following this event, products from company "Y" are sold to a company "Z". Is it possible to change in the Brazilian regsitration license the legal manufacturer from
company "Y" to company "Z" ?
Thank you !

No, because company Z was not bought, or merged, with company X.

 

[tibon74]

thank you Marcelo !
have you the law talking about that ?

 

[Marcelo]

The current regulation is RESOLU??O ANVISA No 22, DE 17 DE JUNHO DE 2010, but it?s being revised.

 

[tibon74]

Thank you !
this regulation talk about the registration holder (BHR) not legal manufacturer, no ?

have you any details about changes in the new law?

 

[Marcelo]

this regulation talk about the registration holder (BHR) not legal manufacturer, no ?

Oh, sorry, I read your comment and understood it in another way.

You can change the legal manufacturer, but only if the belongs to the same group. This is not the case in the example you mentioned, so you would not be able to do it (there would be a need of a new registration).

 

[SharrySteve1]

I agree Inmetro certificate can be used under certain conditions "for medical device under IEC60601-1, Inmetro certificate can be used without approval in origin country."