Informational Medical Device Registration Process in Brazil - Anvisa (Part 3)

apuigvert

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RDC 270 changes the registration process for class I devices to a notification process, so after it begins enforcement, to put a class I device into the market in Brazil, you only need to ask ANVISA for a notification number, they will give you the number in 30 days and then you can put the device into market.
Thank you!
 
Hi Marcelo,

I've just joined the site and it seems you have been very helpful to many people over the last few years, so I'm hoping you won't mind if I ask you a few questions.

We have a CE approved Class I medical device which is currently manufactured and actively marketed in Europe. We have also just received FCC electrical approval. The device connects via a USB connection to a PC so there is no external power and the enclosure is shielded.

We have a partner in Brazil and have discussed with them adding a second manufacturing location in Brazil to overcome regulatory and customs obstacles.

My questions are as follows:

1) given we have CE and FCC approval (and their is no external power), is this likely to have a positive impact on the time taken to achieve InMetro approval?
2) is it advisable/necesary to have the local (Brazilian) manufacturer to apply for InMetro approval?
3) is it advisable to have a local legal representation to process the Anvisa application so we don't have a problem if we add additional distributors?

Any other guidance you can give would be very gratefully received.

Many thanks in advance.


Jon
 

Marcelo Antunes

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Staff member
Admin
Hello Jon, and welcome to the Cove!

1) Given we have CE and FCC approval (and their is no external power), is this likely to have a positive impact on the time taken to achieve InMetro approval?
Not necessarily. Inmetro certification can use test reports from abroad, and if they are acceptable, they will have a positive impact on the time (because you do not have to retest), but CE and FCC approval means nothing in principle.

2) is it advisable/necesary to have the local (Brazilian) manufacturer to apply for InMetro approval?
It's a requirement that the ANVISA registration holder in Brazil (whoever it is) apply for the Inmetro certification.

3) is it advisable to have a local legal representation to process the Anvisa application so we don't have a problem if we add additional distributors?
You can use consulting services that act as BRG (Brazilian Registration Holders). I myself am against this, because I think they are too risky from a business standpoint, but if it make sense to your business, it's an option.
 

max.polix

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Subject: Techincal Responsible person before ANVISA.
I understand that the BRH must appoint a person to be the Techincal Responsible before ANVISA.
What are the requirements for this role?
Education background,
must be an employee of the firm?
is the Technical Responsible supposed to sign the product registration application?
What is role, if any, for the Tecnovigilancia?

Thanks.
Massimo
 
Last edited:

Marcelo Antunes

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Staff member
Admin
Subject: Techincal Responsible person before ANVISA.
I understand that the BRH must appoint a person to be the Techincal Responsible before ANVISA.
What are the requirements for this role?
Education background,
must be an employee of the firm?
is the Technical Responsible supposed to sign the product registration application?
What is role, if any, for the Tecnovigilancia?

Thanks.
Massimo
The only requirement for a Technical Responsible person is that he be a "professional legally qualified by the respective professional council for the activity that the company carries out in the area of products covered by the manufacturer".

He need to be an employee (but he can be employed by other companies, too).

Both the legal and technical responsible person needs to sign the product registration application.

Tecnovigilância is the name for the Vigilance part of the ANVISA medical devices regulations. Each registration holder need to have a person assigned to the role of Tecnovigilance responsible person.
 

max.polix

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Thanks, Marcelo.

We are talking of medical devices: must a "professional legally qualified" be a biomed engineer?
Not clear to me "He need to be an employee (but he can be employed by other companies, too). " My question is if he needs to be an employee of the BRH company. Can we use a consultant for that role?
I believe you understand I need to define sort of a job description for that role.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
Thanks, Marcelo.

We are talking of medical devices: must a "professional legally qualified" be a biomed engineer?
Not clear to me "He need to be an employee (but he can be employed by other companies, too). " My question is if he needs to be an employee of the BRH company. Can we use a consultant for that role?
I believe you understand I need to define sort of a job description for that role.
If the biomedical engineer is registered in his professional council, yes,

He needs to be an employee of the BHR. and yes, it can be a consultant.

unfortunately, there's not much clear requirements, so you need to develop your own.
 

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