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

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C

Compliance Officer

#21
Re GMP
I think I have confused us both here, we were told our class IIa devices were exempt from GMP, however we did have to have a one day site inspection at our manf facility to inspect the device we intended to register in Brazil, this had to be done by an approved ANVISA company, rather than sending one of our devices to Brazil for testing

does that make sense?
thanks
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#22
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??
Hum, so your situation is more complex.

If you could explain it a little it might be easier to help:

- what you mean by "time out"? Did ou have any "technical demands" (documentation NCs)? Did you you not complay to technical demands? Your first submission was already cadastre, right?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#23
I think I have confused us both here, we were told our class IIa devices were exempt from GMP, however we did have to have a one day site inspection at our manf facility to inspect the device we intended to register in Brazil, this had to be done by an approved ANVISA company, rather than sending one of our devices to Brazil for testing

does that make sense?
No. There?s no "approved ANVISA company". Only ANVISA performs GMP inspection.

You are probably talking about INMETRO certification, which is another matter. Is your device a medical electrical equipment? If so, you also need an INMETRO certificate, which, besides testing, requires a quality system verification , and is performed by a certification body.
 
C

Compliance Officer

#25
Regarding the time out, no we had not been asked for anything, we believed this was an administrative error on ANVISA's part. Which in Dec they confirmed when the said our appeal was successful
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#26
Regarding the time out, no we had not been asked for anything, we believed this was an administrative error on ANVISA's part. Which in Dec they confirmed when the said our appeal was successful
Well, I still do not understand.

You did have your cadastre submission denied? That?s what happened? If so, why?
 
T

thalisugisawa

#27
I can't find the English file for the Self-Audit to renew the International ANVISA-GMP Certificate. Any help?
 
D

DPT Energist

#29
Hi,
This is my first post but I find all the questions and answers a great resource. A big thank you to all who post and reply!
I am having an issue with Brazil also.
We produce a Class IIb medical device - electro-medical
Quality system in place.
System type tested by BSi to conform to 60601 3rd edition.
We have been inspected and put right the NC's. (Minor)
(Tip: For any new electro medical device the limits are different for the electrical tests such as leakage, touch, etc as they use lab values)
The problem comes on device registration.
They will not accept type testing report from BSi because they are not ILAC approved.
I have tried demonstrating (via our distributor) that as a UKAS approved organisation, then BSi are a conforming test house.
If not, how do I get an acceptable test report from an ILAC approved test house in the UK. TUV and InterTek both say they are not ILAC approved.
any advice will be greatly appreciated.
Many thanks
Darren
 

tibon74

Involved In Discussions
#30
Hi every body,

Who could explain me the meaning of Critical analysis report ? ANVISA request this document for an implant registration.

thanks!
 
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