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

somashekar

Staff member
Super Moderator
#71
Not sure what you are talking about when you mentioned "lose on their revenue".
BRH mediates between the company and the ANVISA. The fee charged by the BRH includes ANVISA fee + BRH service charges.
When a company provides a letter of authorization to the BRH, this letter will include the committment of BGMP fee as well, and its associated BRH service fee. When a company opts for the MDSAP then obviously the BRH will lose on their revenue. Hence a BRH will never encourage company to take up MDSAP. Their ABIMED comes in handy to speeden up the process. Perhaps the BRH never know the parallel MDSAP process now exists as a pilot on a 3 year trial period
Unlike ANVISA BGMP fee, the FDA do not charge any fee, and there are no mediators between FDA and company.
Now comes the next catch. When a company takes up the MDSAP, they pay the AO. If the company waits for FDA, its free. But when FDA inspection is applicable to the company, and the company wants to expand the market, then MDSAP may help. They therefore land up paying the AO and eventually cover the FDA inspection also at a cost.
So how popular is this MDSAP after 16 months of pilot out of the 36 months which included the AO recognition period as well ... ??
 

tibon74

Involved In Discussions
#72
hello somashekar,

for information, even if you are inspected by FDA according to the MDSAP program, you still need to be inspected by ANVISA and thus to pay the ANVISA inspection fees. ANVISA is in the MDSAP prg but, in reality, they do not use MDSAP inspection report to publish a B-GMP certificate.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#73
BRH mediates between the company and the ANVISA. The fee charged by the BRH includes ANVISA fee + BRH service charges.
A BRH, by definition of the regulations, do not "mediate" anything. It?s the fully responsible registration holder for the product in Brazil, even if the product is manufactured abroad.

When a company provides a letter of authorization to the BRH, this letter will include the committment of BGMP fee as well, and its associated BRH service fee.
This depends on the agreement. There?s no rule for that. I?m not sure what you mean by "BRH service fee" (probably an additional fee the BHR service requires for handling the BGMP certification process - BRh services did not include this in the past, for example).

When a company opts for the MDSAP then obviously the BRH will lose on their revenue. Hence a BRH will never encourage company to take up MDSAP.
Depends on how much we are talking about. As mentioned above, in the past there was no "revenue" related to BGMP certification. If the services are requiring a fee right now - and I know some are - it will depend on how much they are getting out of it. As I mentioned on the last, post, historically BRH services did not profit from this, but from having a device registered in Brazil.

Also, as I mentioned before too, those services do what they are paid to do. If you, as the original manufacturer, conclude that you want to use MDSAP, you simply do that. There?s not need to "encourage a company to take up MDSAP", it?s the company decision, not theirs.


Their ABIMED comes in handy to speeden up the process. Perhaps the BRH never know the parallel MDSAP process now exists as a pilot on a 3 year trial period.
Well BRH services have already profited for years from the lack of knowledge of their clients. There?s nothing new in this case.


Now comes the next catch. When a company takes up the MDSAP, they pay the AO. If the company waits for FDA, its free. But when FDA inspection is applicable to the company, and the company wants to expand the market, then MDSAP may help. They therefore land up paying the AO and eventually cover the FDA inspection also at a cost.
Yes, as I mentioned, it was created as an alternative. That?s also why it?s optional.

So how popular is this MDSAP after 16 months of pilot out of the 36 months which included the AO recognition period as well ... ??
Well, it?s a question participating the regulatory authorities should be asking, right? Although I think they should have asked and answered that before beginning the program.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#74
for information, even if you are inspected by FDA according to the MDSAP program, you still need to be inspected by ANVISA and thus to pay the ANVISA inspection fees. ANVISA is in the MDSAP prg but, in reality, they do not use MDSAP inspection report to publish a B-GMP certificate.
Nope. ANVISA WILL use the MDSAP report in lieu of the ANVISA inspection report, as already mentioned in a lot of different places. Only thing is that up until now they have not received any (well, at least until January when I got the last information).
 

somashekar

Staff member
Super Moderator
#75
So
ANVISA accept the MDSAP as well as they inspect per the BGMP
FDA accept the MDSAP as well as they inspect per the cGMP
HC accept the MDSAP as well as they accept the CMDCAS 13485
TGA accept the MDSAP as well as they perform the routine TGA Inspection
Japan's MHLW is observing the MDSAP
WHO is observing the MDSAP
Certain CB's authorized as AO for the MDSAP also audit and certify for the ISO 13485
ISO 13485 is up for next revision as well (currently 2003)
EU is keeping a watch and continue with the MDD NB assessments and CE mark
Many other regulatory regions are respecting the CE mark
There is the IMDRF, AHWP, SFDA of China.
.
..
...
Seems like Medical devices is the most risky business
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#77
ANVISA accept the MDSAP as well as they inspect per the BGMP
FDA accept the MDSAP as well as they inspect per the cGMP
HC accept the MDSAP as well as they accept the CMDCAS 13485
TGA accept the MDSAP as well as they perform the routine TGA Inspection
Japan's MHLW is observing the MDSAP
WHO is observing the MDSAP
Certain CB's authorized as AO for the MDSAP also audit and certify for the ISO 13485
ISO 13485 is up for next revision as well (currently 2003)
EU is keeping a watch and continue with the MDD NB assessments and CE mark
Many other regulatory regions are respecting the CE mark
There is the IMDRF, AHWP, SFDA of China.
You are mixing a lot of different topics here, but yes, that?s how things are right now. We are in a transitional period with a lot of changes, but please note that this is common in any regulated area.

Seems like Medical devices is the most risky business
Not sure why, in fact almost all of those changes are to make things easier.
 
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Marcelo Antunes

Addicted to standards
Staff member
Admin
#78
I know that according to the new law 3,097/2015 ANVISA may accept the inspection report MDSAP but I understand that they need to update the regulation.
The regulation was published in 2014, it?s RDC 15. The change in the law was done to make the regulation lawful :p. Obviously, they should have done it the other way around, but my impression is that they needed a political maneuver due to being part of the MDSAP program, so they created the regulation (which was quicker to do), and then changed the law as it took more time.

I suppose that we still need to pay inspection fees with a MDSAP inspection report . right?
Nope, if you use the MDSAP you will be granted the certificate based on the MDSAp report, so you don?t need to pay for the inspection fee (you only needed to pay for the inspection because the inspection was the only way to get the certificate).
 

tibon74

Involved In Discussions
#80
Hi 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) ?
 
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