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

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J

JKICD

#31
Hello everyone,

It's my first post here and i found really valuable information thanks to all of you and especially thanks to Marcelo. So a special thanks to you Marcelo!

Especially, i have really appreciated your overview of themedical device registration process in Brazil-ANVISA.

I'd like to know if you have some timeline related to each steps. I understand it's not exact time and could vary but it would be helpful to have an idea of the duration of the process for each step.

For your information, our product is a Class IV electro-medical device.

Finally, how do we know if we need the Economic Information report?

Thanks a lot,

J
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#32
Hello Darren, and Welcome to the Cove!

The requirements from the Brazilian certification process and ANVISA registration is that only test reports performed by ILAC or IAAC traceable test houses (meaning, they are accredited by and accreditation body which is part of the ILAC or IAAC MOUs) are accepted in Brazil. If you can?t find one in the UK (which is find weird), you may need to test in another country. You may even test in brazil, that?s what a lot of manufacturers do.
 

Marcelo Antunes

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Admin
#33
Who could explain me the meaning of Critical analysis report ? ANVISA request this document for an implant registration.
Not exactly sure, is it related to risk management, or manufacturing process, or validation? Do you have any other information?
 
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Marcelo Antunes

Addicted to standards
Staff member
Admin
#34
Hello J and welcome to the Cove!


It's my first post here and i found really valuable information thanks to all of you and especially thanks to Marcelo. So a special thanks to you Marcelo!
Thanks!

Especially, i have really appreciated your overview of the medical device registration process in Brazil-ANVISA.

I'd like to know if you have some timeline related to each steps. I understand it's not exact time and could vary but it would be helpful to have an idea of the duration of the process for each step.

For your information, our product is a Class IV electro-medical device.
GMP certificate - more than 2 years by now

INMETRO certification - estimate is always between 6 and 10 months, depending on a lot of factors (for example, if the test reports from abroad can be used or not)

ANVISA registration for medical electrical equipment - right now estimate is between 6 and 12 months.

INMETRO certification time and ANVISA registration time can vary (even being less than the estimate) depending on a lot of factors and the volume of work from ANVISA

Finally, how do we know if we need the Economic Information report?
There?s a list of products which require economic informations, it?s in RE N? 3385, DE 13 DE OUTUBRO DE 2006

http://portal.anvisa.gov.br/wps/wcm/connect/3e0c99004944422d8812dc1cfdd4e1ac/RE_n_3385_de_13_de_outubro_de_2006.pdf?MOD=AJPERES
 

tibon74

Involved In Discussions
#35
Hi Marcelo,

Thanks. You can see the request :"[FONT=&quot]You should submit a critical analysis report, incorporating the results of tests provided by the company compared with the parameters specified in the design and parameters described in scientific literature to ensure the performance, safety and efficacy for the proposed use of the product under the registration request"

Have you any idea concerning this kind of request ?

Thanks again !
[/FONT]
 

Marcelo Antunes

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Staff member
Admin
#36
"You should submit a critical analysis report, incorporating the results of tests provided by the company compared with the parameters specified in the design and parameters described in scientific literature to ensure the performance, safety and efficacy for the proposed use of the product under the registration request"
Yes, this is related to validation.

You have do perform literature review (including clinical trial and studies), and also testing in accordance with your planned arrangements for the device, and then you have to perform a critical analysis of the results from the tests and literature review and correlate them with your device intended use, device characteristics and technology to confirm that the review and testing shows that the device is safe and effective.
 

tibon74

Involved In Discussions
#40
Hello every body,

We will be inspected by ANVISA soon. 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 ?

Thanks!!!
 
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