Medical Device Registration Process in Brazil - Anvisa (Part 2)

For a foreign company, How long will an ANVISA inspection take? How many inspectors there are during an inspection ? What is the program of an ANVISA inspection ?

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5 days is the common defined time, however, it can take less in some cases.

There are usually 2 inspectors.

Usually there's no program (recently they've been using a very high level plan which only defined initial and final meetings, but nothing clear in between).

thanks Marcelo !!!!

Hi everybody,

We have some changes linked to medical devices (instruments class I and II, implants class III and IV) approved in Brazil:
- Change of manufacturing sites
- change of design of an implant
- change raw material of an instrument
- automation of a manufacturing step of an implant
- Change of control process

Is it an important changes?
What are impacts on the registrations in Brazil ? What do we have to do? Which documents does ANVISA need? What is the time needed to do these changes? Could the products be stopped at the customs if they are impacted by these change?

thanks!!!!

Is it an important changes?

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From the point of view of what to do, the first is the worst change.

What are impacts on the registrations in Brazil ? What do we have to do? Which documents does ANVISA need? What is the time needed to do these changes? Could the products be stopped at the customs if they are impacted by these change?

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In the case of the first, you need to require a new GMP certificate. Takes a while. And you may even have problems in customs.

Hi Marcelo!

thank you !!
And for other changes ?

Hello every body. We have a distributor in Brazil which is the registration holder (BRH) of our products (implants class III and IV and instruments). It require to ANVISA a GMP inspection and we will be inspected soon (this summer probably).
For our new products we would like to use an independent BRH. Could we use the B-GMP inspection certificate with the first distributor to submit regsitration application with the independent BRH ?
thanks !

Not directly. You will need to pay the fee, and then when requesting the inspection you mentioned that the plant is already certified. Then they will probably give the other certificate without physically inspecting the plant.

Our product has cadastre in Brazil, but our distributor is not funcitioning as he should. Do not expect improvements. His contract ends at the end of this year, so we are looking for a new distributor, thinking that the new distributor will have to cadastre the product again, and that that will take 6 months or more. Now we heard from someone who acts as IRH that it would take only one or two months. Have things changed in that aspect recently? Of course 1-2 months would be perfect but we want to be sure. The current cadastre of the product runs until 2016.

I doubt it. Even cadastre is taking some six or more months right now, depending on the product.

thanks Marcelo !