Medical Device Registration Process in Brazil - Anvisa (Part 1)

Re: Medical Device Registration Process in Brazil - Anvisa

Regarding my second question, it is my understanding that all BGMP inspections for a device need to be completed and certificates issued to the local registration holder prior to submitting the technical dossier in support of a new registration. Is this correct?

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Yes, because the certificates are some of the required documents for registration and have to be submitted together (you cannot amend the submission anymore).

Is the situation the same when filing an amendment? Does the registration holder need to wait for the new CM to be inspected and approved before the amendment can be submitted? Or can the amendment and inspection happen in parallel?

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Oh now I understand the question. If you already have the registration, you can then change the plant and request the inspection...someday the plant will be inspected, but meanwhile the registration is still valid.

Lastly, regarding the raw material supplier, I would like to elaborate that my company purchases the material directly from the supplier in it's polymer form. So the supplier in question actually manufactures the polymer from a powder and then sells it to us in solid bars. These bars are then shipped directly to a different contract manufacturer where the machining portion of the manufacturing process begins. Would the raw material supplier still be exempt from inspection?

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Yers, the GMP is worried about the manufacturing process of the medical device and supported processes, for example the process of acquiring and evaluating raw materials, but not the "manufacturing" of the raw materials.

Anyway, the final word on this is from Anvisa. During the petition for inspection, you have to show them the manufacturing process, and if you say this regarding the raw material supplier and they think they need to inspect it, then they will do it.

But in my opinion, it would not be applicable - you as the "manufacturer' of the device must control your suppliers.

Re: Medical Device Registration Process in Brazil - Anvisa

You havce been most helpful, Marcelo. Thank you!

Re: Medical Device Registration Process in Brazil - Anvisa

Ok, Marcelo, last question for the day:

If we have registrations that were approved previous to the implimentation of RDC 25/2009, will we be required to have the BGMP inspections completed prior to submitting our registration renewal? Or can we submit the registration renewal in parallel with planning the inspections?

Thanks!

Re: Medical Device Registration Process in Brazil - Anvisa

If we have registrations that were approved previous to the implimentation of RDC 25/2009, will we be required to have the BGMP inspections completed prior to submitting our registration renewal? Or can we submit the registration renewal in parallel with planning the inspections?

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Have you already required the inspection? If so, when?

Re: Medical Device Registration Process in Brazil - Anvisa

We have never had our CMs inspected. The registrations were approved in 2010, so we will need to renew them in 2015.

I would like to understand if we will need to include the CM inspection certificates in the renewal (i.e., have the sites inspected prior to submitting the renewal request), or if we can request for the inspections and file the renewal in parallel.

Re: Medical Device Registration Process in Brazil - Anvisa

We have never had our CMs inspected. The registrations were approved in 2010, so we will need to renew them in 2015.

I would like to understand if we will need to include the CM inspection certificates in the renewal (i.e., have the sites inspected prior to submitting the renewal request), or if we can request for the inspections and file the renewal in parallel.

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I understand, but were the inspections required? Since the registration?

There are two options here.

You either need to show the inspection request, or the certificate.

In principle, as it´s a renewal, Anvisa would accept the inspection petition.

However, the general rule is that petitions for renewal must show the certificate.

My main concern is not related to the rules but more on the perception Anvisa might get.

If you have not required the inspection, they might be inclined to ask for the certificate because you should have required the inspection by this time (even more so knowing that the inspections are 2 years late).

Didn´t your registration holder warned you about this?

Re: Medical Device Registration Process in Brazil - Anvisa

Marcello - Thank You for all the help you are giving people in this thread. Your specific answers are *very* helpful.

More people should be using the "Thanks" button on your posts.

I personally appreciate your helping and sharing very much.

Re: Medical Device Registration Process in Brazil - Anvisa

Perhaps I do not have a good understanding of the ANVISA regulations....

We have not yet been required by ANVISA to have any inspections. However, since we have registrations expiring in 2015 and have been led to believe that we will need to have our CMs inspected by renewal time, we intend to file inspection requests for all of our CMs in the next few months.

Our previous regulatory consultant in Brazil advised us that we would need to file a request for inspection and have the inspections completed and approved prior to submitting a petition for renewal. So she basically advised that we would need to treat our expring registrations as "new registrations" when we renewed. I would like to confirm if she was correct, that's all

THANK YOU FOR ALL OF YOUR HELP!

Re: Medical Device Registration Process in Brazil - Anvisa

Marc, is it not the same thing to say thanks within the body of a message? I apologize for not hitting the "thanks" button. I didn't see it at first.

Re: Medical Device Registration Process in Brazil - Anvisa

We have not yet been required by ANVISA to have any inspections. However, since we have registrations expiring in 2015 and have been led to believe that we will need to have our CMs inspected by renewal time, we intend to file inspection requests for all of our CMs in the next few months.

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Just to make things clear then, Anvisa won´t request that "you" have any inspections. It´s the responsibility of the Brazilian registration holder to verify the regulatory needs of devices they have registries in Brazil.

Our previous regulatory consultant in Brazil advised us that we would need to file a request for inspection and have the inspections completed and approved prior to submitting a petition for renewal. So she basically advised that we would need to treat our expring registrations as "new registrations" when we renewed. I would like to confirm if she was correct, that's all

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This is the general rule, however, due to problems with supply and demand Anvisa has been accepting the inspection petition instead of the certificate. This is explained in a technical note and is what is being happening.

Not sure if this "previous regulatory consultant in Brazil" is your registration holder, but if so it´s his responsibility (or should be ) to create with you some kind of regulatory pathway plan for your device here, including some moves which are not detailed in the regulation but which are known from Anvisa (this happens a lot in Brazil).

Sorry for the focus on responsibility, but lately I´ve been somewhat worried about the way the links between manufacturers abroad and BRH in Brazil are happening (mainly related to some problems with my clients and to a lot of questions I got asked that show that some of those performing registration holding sometimes have no clues about their own responsibilities - they usually think that it´s the responsibility of the manufacturer abroad, which is totally wrong).