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

[Marcelo]

currently we are having issues getting the audit report results from ANVISA. The BRH is having issues too. The most I've found has been your attachment nof the Cronograma de inspecoes inter5nacionais-CPROD/GIMEP. other than that there has not been movement other wise.What to do??

Hello, and welcome to the Cove!

I?m not sure I understood your comment, your were inspected and are waiting for the audit report? They do not go to you, they go to your BHR.

 

[bethlaiu]

Hello Marco,
Yes the BRH can't even get a hold of the audit report. At this point we want either be the BRH or have a new distributor as BRH since the current BRH is not working out contractually. Is re-submission necessary? would it be all the steps from the beginning or can some steps be not done since we already have approval through ANVISA? How long would it take?
If we had to change shipment place to direct Brazil distributors, change labeling, change in sterilization bag not process... would re-submission be necessary? How much cost wise am I looking at? How long in months would it take for this whole process?
Thank you ahead of time for your response. I've been running in circles with the distributor and ANVISA.
Beth

 

[Marcelo]

Hello Marco,
Yes the BRH can't even get a hold of the audit report. At this point we want either be the BRH or have a new distributor as BRH since the current BRH is not working out contractually. Is re-submission necessary? would it be all the steps from the beginning or can some steps be not done since we already have approval through ANVISA? How long would it take?

To be the BHR, you need at least an office in Brazil with the required permits. Re-submission is needed because the registration will be given to another company (the new BHR), and it would be all the steps.

Depending on your devices class and if they are in IN 01-2011, it may be easier to wait for the publication of the resolution that will remove the exemption list of IN 08.

If we had to change shipment place to direct Brazil distributors, change labeling, change in sterilization bag not process... would re-submission be necessary? How much cost wise am I looking at? How long in months would it take for this whole process?

You need the registration anyway, and only your BHR can permit the import. So you would need to re-submit anyway.

It?s difficult to talk about costing and timelines without knowing all the details of devices, regulatory pathways, need for B-GMP, etc.

One small example, if you need B-GMP (your devices are class III or IV or are in the exemption lis of IN 02), you will need to require the inspection again, paying the fee again for the new BHR, and enter the line, which is now years in waiting.

 

[bethlaiu]

Class 2 device peripheral guide wires and catheters. Interventional Cardiology.

 

[Marcelo]

Class 2 device peripheral guide wires and catheters. Interventional Cardiology.

Sorry, I didn?t mean that one information such as the device and class would permit a full understanding, I really would suggest you contacted your old BHR or new BHR for him to give you this answer.

Anyway, if it?s a class II and it seems it?s not on the exemption list of IN 02, I?m not sure why you would need the B-GMP certificate and inspection.

 

[bethlaiu]

This audit happened before I came on board, so the reasoning I have no clue. But it happened and now I have to try to get this audit report from a BRH who says they've been contacting ANVISA weekly with no response. I can't get it. I've been told it's completely in the hands of the BRH. At this point what can you do?

 

[Marcelo]

This audit happened before I came on board, so the reasoning I have no clue. But it happened and now I have to try to get this audit report from a BRH who says they've been contacting ANVISA weekly with no response. I can't get it. I've been told it's completely in the hands of the BRH. At this point what can you do?

The first thing you need to answer is - do you need the B-GMP certificate? If your device is under the cadaster process (class II minus exemption list of IN 02), you do not the certificate for Brazilian registration. If it?s under the registro process, you do need the certificate.

If you are going to use a new BHR, my suggestion is that this new one perform analysis and creates an regulatory strategy plan for your devices...BHRs generally do not do that and thus you, abroad, does not have the full information that you need to have to take decisions.

 

[Marcelo]

You should also ask your current BHR for clarifications on why you need the B-GMP certificate if you don?t know why.

 

[Ctgio]

Hello, and welcome to the Cove.

The MDSAP program is still in pilot, which began this January - ANVISA is expecting to receive the initial reports from Canada in the beginning of the second semester of 2014. It will take some time (in my opinion, at least until next year) for it to be fully implemented and functional.

So I don?t think it will be useful to you now.

Hi, Thanks for the quick reply. Even if somewhat negative for me.

For your information, I have received no news from our notified body (BSI) about the MDSAP program. If other news are coming, I will update you all.

 

[tibon74]

Hello Marcelo!

I know that we have to wait 90 days after the submission of an ANVISA inspection request to begin a legal procedure (MANDATO DE SEGURANCA) and then ANVISA have to reply within 90 days (maximum) and so on …I would like to know if we are talking about working or calendar days.

thank you !

Taieb