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

[kellascat]

My company is planning on selling a class 1 (cadastro) medical device in Brazil. We found a distributor that would be the product's BRH for ANVISA.

Is it typical to have an agreement with the distribtor in regards to who is responsible for the regulatory pre-market and post-market responsibilites?

Does anyone have an example agreeement?

 

[tibon74]

Hello!

Could we change the legal manufacturer of a product in Brazil? for example, following to an acquisition of a company by another one.

thank you !

 

[somashekar]

Hi Marcelo...
What is the status of the Medical Device Single Audit Program (MDSAP) working group, where Brazil is also a member.
With the factory being in India for a USA manufacturer, How will ANVISA conduct the B-GMP audit for a class III device, which already is through with the INMETRO certification.
Will my ISO 13485 certificate having ANAB accreditation fill the gap till such time MDSAP come out with some recognitions.
Also, is it true that there are agencies recognized now by ANVISA in Brazil who can audit for the B-GMP globally.

 

[somashekar]

Look into this attachment. Gives good details ....
The has clear 'No copyright' statement at the end.

<< I am not associated with EMERGO >>

 

[Marcelo]

Could we change the legal manufacturer of a product in Brazil? for example, following to an acquisition of a company by another one.

Only after an acquisition or merger. There?s a new public consultation on the revision of the current regulation.

 

[Marcelo]

With the factory being in India for a USA manufacturer, How will ANVISA conduct the B-GMP audit for a class III device, which already is through with the INMETRO certification.
Will my ISO 13485 certificate having ANAB accreditation fill the gap till such time MDSAP come out with some recognitions.

No, if you have a class III device plant, ANVISA will need to inspect and have a report to give the GMP Certificate.

Right now, you can use the MDSAP option to be audited, and then the report can be used (in lieu of the ANVISA inpection report) to get the GMP Certificate.

Also, is it true that there are agencies recognized now by ANVISA in Brazil who can audit for the B-GMP globally.

Not in Brazil, only the CDMCAS ones, as part of the MDSAP program.

 

[somashekar]

A question with true / false answer and comments please

1. There is ISO 13485 certificate from a CMDCAS recognized CB
2. There is CMDCAS ISO 13485 certificate from a CMDCAS recognized CB

SO.

a) 1. = B-GMP certification
b) 2. = B-GMP certification
c) 1. & 2. = B-GMP certification
d) 1. & 2. = not a B-GMP certification

 

[Marcelo]

Nope. Sorry, maybe I was not clear.

Being a CDMCAS CB is not enough, they need to be recognized under MDSAP (right now only CDMCAS CBs can apply for MDSAP).

Also, the audit report by an MDSAP-recognized CB is used, they won't issue certificates.

So, option d).

 

[somashekar]

>>> The BRH maintain control over the BGMP certification and device registration.
>>> The Manufacturer has to directly approach the AO for the MDSAP pilot.
So why would the BRH's encourage the company to take up the MDSAP and lose on their revenue. If the BRH is a member of the ABIMED (Which most of the BRH are anyway) they would take up the BGMP process as well through the letter of authorization....
I see a conflict of interest here between the BRH (with ANVISA working allowance permit) and the IMDRF MDSAP pilot.
No wonder the MDSAP has not taken off as anticipated ... ???
Similar in the FDA ... ?
Has FDA and ANVISA committed that they will stop the routine inspection / BGMP audit and instead promote the MDSAP .. ???

 

[Marcelo]

Are you talking about BHR "services"? If so, they usually do not encourage anything, they simply do what they are paid for.

Not sure what you are talking about when you mentioned "lose on their revenue". Usually, the a BHR service only gains something by having devices being sold in Brazil (they usually gain money in in the importation license, because the cost for registration is low and they usually asks for a fixed pricing for maintaining registrations), so the quicker the registration is done, the better for them.

I don?t understand your comment "If the BRH is a member of the ABIMED (Which most of the BRH are anyway) they would take up the BGMP process as well through the letter of authorization.... ". Yes, if the BHR is a member of ABIMED, they can help speed up the registration process by speeding up the GMP certificate using the ABIMED mandate. This has nothing to do with the MDSAP.

And no, nor FDA or ANVISA will "commit to stop the routine inspection / BGMP audit and instead promote the MDSAP". MDSAP is an alternate route, and it was created basically to help regulators solve their problem of inspection queues.