Are New Brazil Class I Medical Device Regulations Expected?

[pittmatj]

I've heard that ANVISA is proposing to eliminate the requirement to register Class I products before cadastro.

Does anyone know approximately when ANVISA expects to implement the new regulations?

 

[Marcelo]

Re: New Brazil Medical Device Regulations

I've heard that ANVISA is proposing to eliminate the requirement to register Class I products before cadastro.

Not sure what you mean, but the proposal is that all classes I and II devices will be under the cadastro process, and they will not need revalidation.

Does anyone know approximately when ANVISA expects to implement the new regulations?

From a meeting I had with ANVISA today, they told me their expectation is that the regulation is published at the end of the year.

 

[pittmatj]

Re: New Brazil Medical Device Regulations

Not sure what you mean, but the proposal is that all classes I and II devices will be under the cadastro process, and they will not need revalidation.




From a meeting I had with ANVISA today, they told me their expectation is that the regulations is published at the end of the year.

Thanks Marcelo, I was thinking that low risk devices were going be regulated the same way as Class I devices in Europe (i.e., no registration procedure and just documentation). Here is an article:

The main change proposed is to eliminate the requirement of importers and manufacturers to register Class I products before cadastro

http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=87227&elq=36cfc50d907b430fb2e28aa019147f72&elqCampaignId=9676


Perhaps I had interpreted that incorrectly.

 

[Marcelo]

Thanks Marcelo, I was thinking that low risk devices were going be regulated the same way as Class I devices in Europe (i.e., no registration procedure and just documentation). Here is an article:

The main change proposed is to eliminate the requirement of importers and manufacturers to register Class I products before cadastro

http://www.medicaldevicedaily.com/se...ampaignId=9676

Perhaps I had interpreted that incorrectly.

Yeah...that?s wrong.

 

[pittmatj]

Yeah...that?s wrong.

Do you have a more reliable source about the upcoming changes?

 

[Marcelo]

Do you have a more reliable source about the upcoming changes?

Maybe the proposal itself?

 

[pittmatj]

Maybe the proposal itself?

Interesting. Can we expect the review timelines for Cadastro to be the same as they are now (8-12 months)? Or do you think the new regulations will significantly expedite the review process?

 

[Marcelo]

Interesting. Can we expect the review timelines for Cadastro to be the same as they are now (8-12 months)? Or do you think the new regulations will significantly expedite the review process?

Hopefully they will be expedited in the future after publication of the regulation, but they have to finish the waiting line first.

Anyway, the line for cadastro is not 8-12 months right now, they have made some progress, it can be seen here and they are already in 2014 for all types of devices, see here - http://www.anvisa.gov.br/listadepeticoes/index.asp

 

[pittmatj]

Hopefully they will be expedited in the future after publication of the regulation, but they have to finish the waiting line first.

Anyway, the line for cadastro is not 8-12 months right now, they have made some progress, it can be seen here and they are already in 2014 for all types of devices, see here - http://www.anvisa.gov.br/listadepeticoes/index.asp

That is good to hear.

I'm undergoing an amendment(alteração por acrescimo) to my original registration and the registrar said it could take "8-12 months" to be processed.

Are the Cadastro amendments on a different track then first time Cadastro registrations? I don't understand why even the most simple change to a registration takes such a long time.

 

[Marcelo]

I'm undergoing an amendment(alteração por acrescimo) to my original registration and the registrar said it could take "8-12 months" to be processed.

Are the Cadastro amendments on a different track then first time Cadastro registrations? I don't understand why even the most simple change to a registration takes such a long time.

For a registro process, it can take some time. Also for cadastro, but as I mentioned the cadastro line is not that big now.

The long time is because ANVISA does not have enough people to perform the reviews.

Also, sometimes the registration holder (particularly if it´s a consulting BRH service) just says that it takes a long time because he really does not care and don´t want to be accountable (so if it takes less it can say that it got a "premium").