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andyrocha90

Re: Medical Device Registration Process in Brazil - Anvisa

Hi Marcelo, first of all, thanks for all the information you have posted on this thread, it has been of great help. I have a question regarding classification & fees, I have 2 products i'm planning on importing to Brazil, one is a Blood Glucose Monitoring System, and the other is a HbA1c Analyzer. I need to know, if possible, under which classification each product falls & what is a good rough estimate of inspection, certification process, testing, and registration costs for each product. It would be highly appreciated. Thanks!

P.S. since im a new user, forum wouldn't let me post links. products are on the ceragemmedisys website
 
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scribeone

Re: Medical Device Registration Process in Brazil - Anvisa

Hello All/Marcelo,
It is my understanding that the registration holder is responsible for scheduling the B-GMP audit on behalf of the manufacturer. What if the manufacturer has two registration holders for different products that are manufactured at the same facility? Which registration holder is ultimately responsible for scheduling the facility audit and can the B-GMP certificate be used to support registrations for both registration holders? Does each registration holder require their own B-GMP certificate, if so, does the manufacturer need to have two inspections and pay the inspection fees twice? I am trying to understand how the B-GMP certificate can be used and if it is tied to only one registration holder or if it can be used to support registration activities for other registration holders. I look forward to your comments, thanks.
 

Marcelo Antunes

Addicted to standards
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Re: Medical Device Registration Process in Brazil - Anvisa

Hello All/Marcelo,
It is my understanding that the registration holder is responsible for scheduling the B-GMP audit on behalf of the manufacturer. What if the manufacturer has two registration holders for different products that are manufactured at the same facility? Which registration holder is ultimately responsible for scheduling the facility audit and can the B-GMP certificate be used to support registrations for both registration holders? Does each registration holder require their own B-GMP certificate, if so, does the manufacturer need to have two inspections and pay the inspection fees twice? I am trying to understand how the B-GMP certificate can be used and if it is tied to only one registration holder or if it can be used to support registration activities for other registration holders. I look forward to your comments, thanks.
Hello and welcome to the Cove!

The certificate is linked to the BHR. So each one will need to require (and pay the fee) for the GMP. However, after the plant get inspected, you can inform Anvisa on this and they will probably not inspect it again, taking into consideration the fact that it was already inspected.

So yes, you can use the certificate for other BRHs, however, each one will need to request the inspection and pay the fee.
 

Marcelo Antunes

Addicted to standards
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Admin
Re: Medical Device Registration Process in Brazil - Anvisa

Can anyone tell me the adverse event reporting timescales for Brazil.
This is defined in RDC 67 -

The general timescales are:

72 hours for death, threat to public health or piracy events.

10 days for hazardous adverse events and some other events

30 days less hazardous events

10 days if death or related to product registered in Brazil, but death in another country
 
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scribeone

Re: Medical Device Registration Process in Brazil - Anvisa

Thanks for the valuable information. I do have a follow-up question. If one BRH requests the B-GMP audit on behalf of the manufacturer but the manufacturer decides to move away from that BRH at a later time can the already scheduled audit be transfered to the new BRH in order for the manufacturer not to lose its place in line to be audited?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
Re: Medical Device Registration Process in Brazil - Anvisa

I do have a follow-up question. If one BRH requests the B-GMP audit on behalf of the manufacturer but the manufacturer decides to move away from that BRH at a later time can the already scheduled audit be transfered to the new BRH in order for the manufacturer not to lose its place in line to be audited?
No you can?t. Problem here is that the only real player in Brazil is the BHR, not the manufacturer (so saying that the BHR does things on behalf of the manufacturer is somewhat wrong, and I probably helped with this misconception the way I wrote things in past posts).

The BHR is fully responsible for the device on Brazil. So he requires inspection for registering the device. It?s his, on this name.

The other way around can happen. If the BHR wants to change the place of inspection (because he changed the original manufacturer), he can.
 
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scribeone

Re: Medical Device Registration Process in Brazil - Anvisa

Thank you Marcelo, you have fully answered my questions.
 
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Dudes

Re: Medical Device Registration Process in Brazil - Anvisa

As an OEM manufacturer (EU class III devices), I have received a request from one of our customers that we should register our company by ANVISA.

I thought only the legal manufacturer had to register the products. (after successfully passing a GMPS audit which can only be requested by a subsidiary/partner in BR). Am I wrong?

What is the procedure to register the company? I could not find any information on how to do it..

Thanks for your help!
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
Re: Medical Device Registration Process in Brazil - Anvisa

I thought only the legal manufacturer had to register the products. (after successfully passing a GMPS audit which can only be requested by a subsidiary/partner in BR). Am I wrong?
Yes, because not even the legal manufacturer can register the product if he?s outsite of brazil. Only Brazilian entities can register products in Brazil.
 
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