Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

H

HYJ_Register

#61
There are two possible ways for you to have a try to avoid long-time costing before products registration:

1.To Find a local company which owns the membership of ABIMED as products' registration holder.ANVISA would temporiraly accepts a foreign GMP certificate that is equivalent to the ISO 13.485, such as the FDA or CE certifications., as long as there is a request for the GMP inspection for longer than six months, for products' registration;

2.To wait for the official publication of N 50 which regulates Class I and II products would no longer request GMP when being submitted process.
 
M

meiiou

#62
Hi all,
I am a new guy here. I have a question about IVD registration in Brazil. Our company is on the process of preparing registration. Before getting the registration from ANVISA, can our product enter into Brazil for exhibition? Does any regulation like "At trade fairs, exhibitions, demonstrations, scientific or technical gatherings, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive provides that such devices are not used on specimens taken from the participants and that a visible sign clearly indicates that such devices can not be marketed or put into sevices until they have been made to comply." in Article 4 of IVDD 98/78/EC exists in Brazil?
I would very appreciate if you could help me. Thanks.

Best wishes.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#63
Hello Meiiou and welcome to the Cove!

I am a new guy here. I have a question about IVD registration in Brazil. Our company is on the process of preparing registration. Before getting the registration from ANVISA, can our product enter into Brazil for exhibition? Does any regulation like "At trade fairs, exhibitions, demonstrations, scientific or technical gatherings, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive provides that such devices are not used on specimens taken from the participants and that a visible sign clearly indicates that such devices can not be marketed or put into sevices until they have been made to comply." in Article 4 of IVDD 98/78/EC exists in Brazil?
Yes, there?s a regulation for that - RESOLU??O-RDC No 13, de 27 Janeiro de 2004.
 

tibon74

Involved In Discussions
#64
Hello!

I know that manufacturers should send a new products (never used) in Brazil.
What is the risk if a manufacturer send and use old (already used) reusable instruments (class I or II) in Brazil? [FONT=&quot]a fine or a cancellation of the registration…?[/FONT]
many thanks !
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#65
I know that manufacturers should send a new products (never used) in Brazil.
What is the risk if a manufacturer send and use old (already used) reusable instruments (class I or II) in Brazil? a fine or a cancellation of the registration…?
many thanks !
Selling,you mean? By law, you cannot sell used devices in Brazil (unless they are refurbished by the Brazilian registration holder).
 

tibon74

Involved In Discussions
#66
ok thank you!
What is the sanction (penality) if the manufacturer sells used devices ?
do you have the law?
 
Last edited by a moderator:

Marcelo Antunes

Addicted to standards
Staff member
Admin
#67
Well, it depends on several factors, but may range from a fee to total import prohibition . Anyway, the product is considered adulterated.

The regulation on use equipment is RDC n? 25/2001.
 

tibon74

Involved In Discussions
#69
Hello Marcelo!

In the RDC25/2001 what does "expressive responsibility" mean (for Refurbished products) ?
It is indicate that if the registration holder has an expressive responsibility in the renovation we can import Refurbished products. For example, if a manufacturer renovates the products after a request of registration holder, can we import them?

thank you !
 
Last edited:

Marcelo Antunes

Addicted to standards
Staff member
Admin
#70
In practice, it means that the registration holder is responsible for the refurbishment and if not, the device cannot be imported. This is a problem that this regulation have - the refurbishment should be the responsibility of the original manufacturer.

Anwya, if the deice is refurbished by the original manufacturer, and the device complies with the 4 requirements of the regulation, yes, it can be imported. But sometimes there are trouble when importing, even if following this, due to some weird interpretation of the regulation (usually from inspectors in ports and airports).
 
Top Bottom