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Medical Device Registration Process in Brazil - Anvisa (Part 2)

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sreenu927

Quite Involved in Discussions
#11
Hi Marcello,

Hope you are doing good!

I just read this article about Brazil GMP Inspections:

Brazil Drops International GMP Inspection Proposal
Latest News Regulatory Update | Posted: 24 January 2013

By Louise Zornoza, RegLink

The Board of Brazil's national regulatory agency, Anvisa, has abandoned a draft resolution that proposed how the regulatory agency would conduct overseas current good manufacturing practice (CGMP) inspections at medical device and in vitro diagnostic (IVD) manufacturing sites.

Regulators cited comments indicating that the high cost of the inspections would outweigh the benefits of the proposal for the withdrawal of the draft resolution.

Moreover, elements of the earlier proposal are now covered by the recently launched Public Consultation 02/2013 on the conditions for granting Certificates of GMP and Good Distribution Practice (GDP) and Storage.


So does it mean there won't be international inspections to issue BGMP cert to Foreign mfgs?

Appreciate your clarification!

Thanks,
Sreenu
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#12
Hi sreenu927

Nope. The draft resolution from 2011 only suggested some ways to prioritize the inspection line.

Nothing changes.

And take care with those news from regulatory "sources", as always the news you pasted are totally misleading.
 
C

Compliance Officer

#14
Has anyone got a device registration stuck due to the ANVISA strike of last year? We are now approaching 12 months and still no certificate?
Has anyone ever take ANVISA to court to get them to review or approve an application?
Thanks
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#15
Has anyone got a device registration stuck due to the ANVISA strike of last year? We are now approaching 12 months and still no certificate?
Are you talking about device registration or GMP certificate? They are separate matters.

Anyway, device registration might take one year or more for some kinds of devices, and GMP inspections are more than 2 years late as of now.

Has anyone ever take ANVISA to court to get them to review or approve an application?
Sure, this has been common of late (right now a lot of manufacturers are doing this to force ANVISA to perform the GMP inspection). The only problem is that it?s creating a another line - waiting to ANVISA to fulfill other court mandates :-(
 
C

Compliance Officer

#16
for the device registrations, we already have the gmp certifications! we are supposed ot be cadastre/low risk so it would not take as long?

Are they taking ANVISA to court over device approvals?

Thanks
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#17
we are supposed ot be cadastre/low risk so it would not take as long?
Yes, it "should" be quicker.

Are they taking ANVISA to court over device approvals?
Yes, some maunfacturers do, must most don?t because they fear device retaliation.

we already have the gmp certifications!
Just curious, if your devices are cadastre, why did you get GMP certification? Do you have other devices under the registro process?
 
C

Compliance Officer

#18
No these are our first attempts to register in Brazil

We have been told that taking ANVISA to court is commone practice and seen as "the way of life" in brazil, therefore retaliation would be unlikely?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#19
No these are our first attempts to register in Brazil
Well, if you only have devices under cadastre, you do not the GMP certificate. The main problem now is that, if you already have asked for it (not sure why you did it), you will now be expect to maintainit (paying the fees :-().

We have been told that taking ANVISA to court is commone practice and seen as "the way of life" in brazil, therefore retaliation would be unlikely?
Hope that the same people that told you this are not the ones that told you you would need the GMP certificate if you didn?t :p

Anyway, taking ANVISA to court is not really common practice, although in the past few years it has been performed a lot more than in the more distant past.

I myself do think that manufacturers should do this if they really deem necessary. Regarding retaliation, I also think it?s unlikely, but we cannot forget the fact that the ANVISA process is really peculiar because it really depends on the person that is evaluating your device, and in this way it would be easier to things like that happen (in comparison with a more clear system which is less dependant in only one or two opinions).
 
C

Compliance Officer

#20
We had a first submission timed out by ANVISA and then resubmitted the same registration and appealed the time out as we believed this was the fault of ANVISA, however both registrations are now stuck in the mire. However we did hear in Dec that our appeal was successful and they would review the submission, but still we have heard nothing since and continue to be blanked when we ask for an update??
 
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