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

Re: Medical Device Registration Process in Brazil - Anvisa

I'm in the 'fortunate' position of hosting an INMETRO audit (by BRTUV) in two weeks and an ANVISA return audit in 3-4 weeks time. Between this and other, as always pressing, QA/RA matters, my time is quite limited ...

Just now I received word from the BRTUV auditor that I need to know Portaria no. 350/2010 for this audit.

Is there an English translation of this somewhere out there? Did a quick search on internet but nothing much came up.

Marcelo, I found your presentation on Prezi, very helpful but if you'd have an English translation of this Portaria, I'd be eternally grateful to you (until the next revolution, that is ).

Re: Medical Device Registration Process in Brazil - Anvisa

After inspection and technical file are all said and done, what is the approximate wait time between submitting your application and receiving registration?

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After submitting? between 3 and 6 months for equipment related submissions (I would expect that for software too).

Is there a 2 year wait time between request and inspection for all subsequent ANVISA Inspections, or just for the initial registration?

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For all inspections. The problem is lack of personnel.

I've also been finding conflicting information on what to do on GMP off years. Do you submit internal audits to ANVISA, or just keep them on hand unless requested?

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This is really confusing. I'm preparing an explanation table, but it will take some time.

Anyway, a quick answer is:
Certificate is valid for 2 years.
You can revalidate for more 2 years - needs to require revalidation from Anvisa.
Then you need to reinspect.

Re: Medical Device Registration Process in Brazil - Anvisa

Given that Anvisa audits appear to be taking a long time, it is acceptable to permit UL to perform these activities on their behalf (including surveillance audits? I understand that their certification scope is active again. Thanks!

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Nope. Only Anvisa can perform inspection (this has nothing to do with certification schemes, although you are given a certificate ).

Re: Medical Device Registration Process in Brazil - Anvisa

Is there an English translation of this somewhere out there? Did a quick search on internet but nothing much came up.

Marcelo, I found your presentation on Prezi, very helpful but if you'd have an English translation of this Portaria, I'd be eternally grateful to you (until the next revolution, that is ).

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Sorry, I've got a translation but as it was not done by me and I don't have permission to share, there's nothing I can do.

Re: Medical Device Registration Process in Brazil - Anvisa

Marcelo Antunes said:

Sorry, I've got a translation but as it was not done by me and I don't have permission to share, there's nothing I can do.

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Thanks anyway. I'll try getting it from either the ANVISA or the BRTUV auditor that I meet this week.

Re: Medical Device Registration Process in Brazil - Anvisa

We were all set to move forward with our device registration in Brazil under the assumption that we would need GMP inspections. However, one of our contractors that we contacted about being our registration holder is telling us that we qualify for cadastro. If this is true, that would be EXCELLENT news for our company, but I can't imagine anything worse than finding out halfway through that we do need inspections and will have to significantly increase our cost and timeline.

Their reasoning is that our PACS device is not "a key part of the diagnosis" and only performs "limited processing." Our device does not control any imaging modalities or alter the original image. It intended for archival, transmission, and viewing images. Radiologists view images through our PACS while performing diagnosis and can use features that smooth, sharpen, enhance, rotate, measure etc. to help them form their diagnosis.

Is there any chance that this would qualify for cadastro?

Re: Medical Device Registration Process in Brazil - Anvisa

I have a couple of questions about the ANVISA inspection process:

1) If we decide to change suppliers, I understand that this would trigger the need for a new inpsection of the new supplier, but would we also need to file a new registration? a registration renewal? or an amendment to the registration?

2) Assuming we could file an amendment for the supplier change, would we need to wait for inspection approval prior to submitting the amendment? Or can we submit the amendment as soon as we receive the protocol (receipt?) for the inspection request?

3) would a raw material supplier fall under the scope of inspection?

Thank you!!

Re: Medical Device Registration Process in Brazil - Anvisa

I should mention that my company manufactures implants.

Also, when I say "supplier", I mean Contract Manufacturer.

Thank you!

Re: Medical Device Registration Process in Brazil - Anvisa

Hello Piranha 10 and welcome to the Cove!

1) If we decide to change contract manufacturer, I understand that this would trigger the need for a new inpsection of the new supplier, but would we also need to file a new registration? a registration renewal? or an amendment to the registration?

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An amendment. You need to change the manufacturing site to the new one.

2) Assuming we could file an amendment for the supplier change, would we need to wait for inspection approval prior to submitting the amendment? Or can we submit the amendment as soon as we receive the protocol (receipt?) for the inspection request?

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You mean, you already required the inspection, but wants to change the site to be inspected?

3) would a raw material supplier fall under the scope of inspection?

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No, raw materials suppliers conformance (to any required requirement by the manufacturer) is done by the manufacturer.

Re: Medical Device Registration Process in Brazil - Anvisa

Thank you, Marcelo!


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?

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?

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?

Thank you again