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

[Marcelo]

Re: Medical Device Registration Process in Brazil - Anvisa

Hello lanadi and welcome to the Cove!

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.

The Brazilian classification is similar to the EU medical device classification scheme (the original one from the MDD).

 

[noshu]

Re: Medical Device Registration Process in Brazil - Anvisa

Hello lanadi and welcome to the Cove!



The Brazilian classification is similar to the EU medical device classification scheme (the original one from the MDD).

Hello Marcelo,
I would like to know that please can you guide me that how a Brazilian company get the INMETRO and Anvisa registration.
I need the information step by step..
I will be thankful if you will help me in this way.

a very good Friday.

 

[Mondo 22]

Re: Medical Device Registration Process in Brazil - Anvisa

Hi Marcelo,


Hope you are well,


How long are ANVISA and BGMP Certificates valid for?

Are they the same certificate?

Thanks,

 

[Marcelo]

Re: Medical Device Registration Process in Brazil - Anvisa

I need the information step by step..

Hello Noshu, step-by-step information on Anvisa registration and Inmetro certification can be found on the attached files to this thread.

 

[Marcelo]

Re: Medical Device Registration Process in Brazil - Anvisa

How long are ANVISA and BGMP Certificates valid for?

Are they the same certificate?

Well, there´s only one certificate Anvisa gives, and it´s be BGMP certificate, so I think you are talking about the same thing.

It´s valid for 2 years.

 

[Marc]

Re: Medical Device Registration Process in Brazil - Anvisa

Also see: Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

 

[Mondo 22]

Re: Medical Device Registration Process in Brazil - Anvisa

Marcelo,
Do you have any further information regarding the amendments to RDC 23 which will need to be complied with as of April 2013.
Is there an English version of RDC 23 (unlikely i know!!) or are you able to highlight the main points.
Thanks and regards,
Ray

 

[tibon74]

Re: Medical Device Registration Process in Brazil - Anvisa

Hi!

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 !
Regards

 

[engmanager]

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.

Thanks.

 

[Marcelo]

Re: Medical Device Registration Process in Brazil - Anvisa

Do you have any further information regarding the amendments to RDC 23 which will need to be complied with as of April 2013.

Nope, sorry!

Is there an English version of RDC 23 (unlikely i know!!) or are you able to highlight the main points.

No english version as always.....you can find the portuguese version in http://portal.anvisa.gov.br/wps/wcm...C_n_23_de_04_de_abril_de_2012.pdf?MOD=AJPERES and can use Google to translate the text.

The focus is on field actions. When there´s evidence that devices do not meet requirements for safety and effectiveness, a field action has to be performed. The rest of the RDC details timelines and other requirements.