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

Re: Medical Device Registration Process in Brazil - Anvisa

We have submitted last september an inspection ANVISA request for our company in France. Is it true that it takes 1 years to have an answer from ANVISA? Is there a rule for inpection schedule ?
thanks !

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In fact, it´s taking 2 years. In may 2012 Anvisa was scheduling inspections requested in June 2010. The are no defined rules (at least oficcially), but Anvisa is scheduling based on request

Re: Medical Device Registration Process in Brazil - Anvisa

I know INMETRO is currently accepting IEC60601 3rd edition.

When will it be required for new submissions?

And, will we have to retest or recertify an already approved device that has approximately 4 years remaining with a current INMETRO certification.

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The certification process currently accepts third edition, however the method of doing this has not been defined yet.

Related to Anvisa registration and cadastre, after January 1st, 2014, only certificates based on the third edition will be accepted.


For a revalidation of registration or cadastre ,you will have to retest the device.

Re: Medical Device Registration Process in Brazil - Anvisa

Marcelo Antunes said:

In fact, it´s taking 2 years. In may 2012 Anvisa was scheduling inspections requested in June 2010. The are no defined rules (at least oficcially), but Anvisa is scheduling based on request

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This thread is definitively a gold mine!

I have just a question relating to this post. I am well afraid of already having the answer but I'm just asking for confirmation!

Must we necessarily have undergone an ANVISA audit to be able to sell in Brazil - ?

Re: Medical Device Registration Process in Brazil - Anvisa

Must we necessarily have undergone an ANVISA audit to be able to sell in Brazil - ?

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If you device requires registration (not cadastre), you need a B-GMP certificate which is given after Anvisa inspect your plant.

Registration is required for class III and IV devices and some few class I and II devices which are in an cadastre exemption list.

Re: Medical Device Registration Process in Brazil - Anvisa

Hi Marcelo, I have a question about transference of registration. If we have got registrations via a local agent before. After we establish an office or a plant in Brazil, can we transfer these registrations from the agent to our office? Certainly, the office or plant will be qualified under AFE, LF and GMP.
Some report said it should be possible. But your confirmation would be appreciated.

Re: Medical Device Registration Process in Brazil - Anvisa

I work for a company that manufactures standalone medical device software used in diagnosis (PACS). It is usually complicated to apply regulations to software, and even more complicated using translated versions. It is my understanding that such software would be a class II device that does not require INMETRO certification, but would require B-GMP inspections. Can anyone verify that? I haven’t come across anything in IN-3/2011 that covers standalone software, but it is listed in IN-2/2011.

Re: Medical Device Registration Process in Brazil - Anvisa

Hi Marcelo, I have a question about transference of registration. If we have got registrations via a local agent before. After we establish an office or a plant in Brazil, can we transfer these registrations from the agent to our office? Certainly, the office or plant will be qualified under AFE, LF and GMP.
Some report said it should be possible. But your confirmation would be appreciated.

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Sorry, I didn´t see this before.

You can´t. You can only transfer registrations via fusions or acquisitions.

Re: Medical Device Registration Process in Brazil - Anvisa

I work for a company that manufactures standalone medical device software used in diagnosis (PACS). It is usually complicated to apply regulations to software, and even more complicated using translated versions. It is my understanding that such software would be a class II device that does not require INMETRO certification, but would require B-GMP inspections. Can anyone verify that? I haven’t come across anything in IN-3/2011 that covers standalone software, but it is listed in IN-2/2011.

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Yes, they would require registration (and thus B-GMP inspection) but not Inmetro certification. Inmetro certification is for medical electrical equipment.

If your software is part of a hardware, the hardware (together with software) will need certification.

There´s a guidance document called "NOTA TÉCNICA N° 04/2012/GQUIP/GGTPS/ANVISA" for software.

Re: Medical Device Registration Process in Brazil - Anvisa

Thank you so much for your previous help. I hope not to be too much of a bother, but I do have a couple more questions.

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

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

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?

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!