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

Re: Medical Device Registration Process in Brazil - Anvisa

Hello Ray and welcome to the Cove!

Is an ANVISA inspection a Quality System inspection and INMETRO part the Product Registration?

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Anvisa is the regulatory body for medical devices in Brazil and where you need to register your device. As part of the registration process, Anvisa requires the certificate of B-GMP (which Anvisa gives after Anvisa inspects your plant). For MEE, Anvisa also requires the conformity certificate issued under Inmetro (which a certification body gives after performing the certification process - type testing and manufacturer plant audit).

I suppose what im asking is how do i go about registering this product?

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Your registration holder in Brazil has to require the B-GMP inspection. The inspection is taking from 8 months to 1 year and a half, maybe more.

In parallel, you can perform the INmetro certification process.

When you have both certificates, you can apply for registration.

How long does it take?

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At the moment, due to the problem of Anvisa inspections, some 2 years.

How much does it cost?

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The Anvisa B-BMP inspections cocts US$ 22.000
The Inmetro certification process costs between US$ 4.000 and US$ 15.000 (not counting tests)
Registration is someting between US$ 200 and 3.000

These are the main costs, there are other minor taxes also and costs also.

Re: Medical Device Registration Process in Brazil - Anvisa

Marcelo,

Thank you so much, you are definitely on the Christmas card list? ha

How do i gain INMETRO certification? Does all testing require to be conducted by a test lab based in Brazil?

Thanks and regards,
Ray

Re: Medical Device Registration Process in Brazil - Anvisa

How do i gain INMETRO certification?

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There´s a lot of information on the Inmetro certification process in this thread: Medical Equipment Inmetro Certification Process in Brazil

Does all testing require to be conducted by a test lab based in Brazil?

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No. You can use tests performed abroad if they met the requirements set forth by Inmetro.

Re: Medical Device Registration Process in Brazil - Anvisa

How long are Inmetro Certificates valid for?

Thanks,
Ray

Re: Medical Device Registration Process in Brazil - Anvisa

How long are Inmetro Certificates valid for?

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5 years.

Re: Medical Device Registration Process in Brazil - Anvisa

Dear Marcelo,Thanks for organized this topic in the thread, it is very helpful to understand the ANVISA and selling product in Brazil. My questions is:

1. We already have one distributor (abbr D1 later) (registeration holder) to sell the products which they had registered with. Can I have a new distributor to register and sell the prodcuts which have not be done by the D1? how about the registered products? it seems we have to wait untill it expire right?

2. I am confuse that who is the best choice for registeration holder as we are the manufacture? indepent frim or distributor in our case? Can you list the advantages and disadvantages?

As we are not satisified with the sells of D1 last year, we are going to authorize some others, however, I'm afraid the same things happen again, in that case, we have no more products to register even we find a new distributor again. On the other hand, I also plan to have a meeting with the D1 about the authorized letter for another distrubutor in Brazil, its like we export to D1 firstly, then they help us to apply the ANVISA, customer clearence etc, finally delivery to real buyer(new distributor)?

Re: Medical Device Registration Process in Brazil - Anvisa

Marcelo,

That information is hugely useful thank you.
Could you tell me, you mention the TGA, I wonder if you can help me - in Australia, if registered under the APVMA, our product becomes exempt from the TGA registration? Is this correct?

Many many thnaks for your help

Re: Medical Device Registration Process in Brazil - Anvisa

1. We already have one distributor (abbr D1 later) (registeration holder) to sell the products which they had registered with. Can I have a new distributor to register and sell the prodcuts which have not be done by the D1? how about the registered products? it seems we have to wait untill it expire right?

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Yes, and yes. You can have another registration holder register new products and you can also have him register the same products the other one registered. You only need to take care with your commercial agreements with D1.

2. I am confuse that who is the best choice for registeration holder as we are the manufacture? indepent frim or distributor in our case? Can you list the advantages and disadvantages?

If for independent firm you mention the consultants which sells a BHR service...

Well, registration holders, in the view of Anvisa, are responsible in Brazil for the medical devie (they are the same as a local manufacturer, so a way to think is that they are the "manufacturers" in the eyes of the law).

Independent (consulting) firms are everywhere here in Brazil, however, my opinion is that they are very risky because, simply, they cannot really fulfill what is require by Anvisa. Also, as they usually have a lot of registrations in their name, if there's some problem in one product, all the other ones could be in trouble (because the registration holder will be in trouble).

however, a lot of manufacturers from abroad use those services because they do not want to be on the hands of only one distributor (might be your case). I understand this need, but I think it's important to understand the risk that having a BHR which is really not a medical device company (they are usually only offices) being in charge of your device.

A good distributor partner is im my opinion the best thing to have. However, it's not that easy to find one.

Real problem here in my opinion: manufacturer from abroad simply wants to "entert the Brazilian market" as quickly as possible so they have no time to really plan how to do it.

As we are not satisified with the sells of D1 last year, we are going to authorize some others, however, I'm afraid the same things happen again, in that case, we have no more products to register even we find a new distributor again. On the other hand, I also plan to have a meeting with the D1 about the authorized letter for another distrubutor in Brazil, its like we export to D1 firstly, then they help us to apply the ANVISA, customer clearence etc, finally delivery to real buyer(new distributor)?

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Yes, that's also possible, in this case D1 could act only as a BHR (and then another distributors take care with selling).

Re: Medical Device Registration Process in Brazil - Anvisa

Hi Marcelo, Thanks for you reply, It's very helpful.

Marcelo Antunes said:

Yes, and yes. You can have another registration holder register new products and you can also have him register the same products the other one registered. You only need to take care with your commercial agreements with D1.

2. I am confuse that who is the best choice for registeration holder as we are the manufacture? indepent frim or distributor in our case? Can you list the advantages and disadvantages?

If for independent firm you mention the consultants which sells a BHR service...

Well, registration holders, in the view of Anvisa, are responsible in Brazil for the medical devie (they are the same as a local manufacturer, so a way to think is that they are the "manufacturers" in the eyes of the law).

Independent (consulting) firms are everywhere here in Brazil, however, my opinion is that they are very risky because, simply, they cannot really fulfill what is require by Anvisa. Also, as they usually have a lot of registrations in their name, if there's some problem in one product, all the other ones could be in trouble (because the registration holder will be in trouble).

however, a lot of manufacturers from abroad use those services because they do not want to be on the hands of only one distributor (might be your case). I understand this need, but I think it's important to understand the risk that having a BHR which is really not a medical device company (they are usually only offices) being in charge of your device.

A good distributor partner is im my opinion the best thing to have. However, it's not that easy to find one.

Real problem here in my opinion: manufacturer from abroad simply wants to "entert the Brazilian market" as quickly as possible so they have no time to really plan how to do it.




Yes, that's also possible, in this case D1 could act only as a BHR (and then another distributors take care with selling).

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Re: Medical Device Registration Process in Brazil - Anvisa

Our product is being sold in the EU as a consumer device and is cleared by the FDA as a Class II OTC. If our competitor already registered their device in Brazil as a class III, how should we classify our device for Brazil? Does ANVISA use the EU classification or the predicate device already registered in their country.