Brazil requirements to have translations of IFU to Portuguese certified

[Bunny]

Are there requirements to have translations of IFU to Portuguese certified?

 

[Marc]

Re: Requirements to have translations of IFU to Portuguese certified

You might want to tell us what country you are referring to.

 

[Bunny]

Re: Requirements to have translations of IFU to Portuguese certified

Brazil.
.

 

[Marc]

Re: Requirements to have translations of IFU to Portuguese certified

Paging Marcello! (He should know)

 

[Marcelo]

Nope, only some regulatory documents need to be "certified", not the IFU.

 

[Lu288]

Hi all,
I understand that IFU in Brazilian Portuguese are required to register a medical device to Anvisa (and we translated everything for that purpose)
I was wondering if we can sell our medical device with English IFU if the customer accepts it (the device is an IVD for PROFESSIONAL use) or if in someway it is mandatory to provide Brazilian Portuguese IFU (for example because there are particular ANVISA requirements)

Thanks all!
Luisa

 

[Marcelo]

It's mandatory.

From RDC 185/2001

ANNEX III.B
INFORMATION ON LABELING AND INSTRUCTIONS FOR USE OF THE MEDICAL DEVICE
1. General Requirements
1.1. The information on the label and on instructions for use must be written in the Portuguese language.***

 

[QM Becky]

Hi Marcelo,
Perhaps you can help me with a question:
We have recently received our ANVISA registration (and have our INMETRO certification as well) and are finalizing our labeling to include ANVISA registration numbers and INMETRO marks for both electrical and metrology.
What I cannot figure out is if the INMETRO marks and/or the ANVISA registration numbers are required to be on the Instructions for use or only on the product and it's device/box labels? We will be including the INMETRO marks in the symbol definition section of the IFU but unclear if it needs to be included otherwise.

Appreciate your assistance,
Becky

 

[Marcelo]

Hello, in the case of ANVISA, RDC 185 item 3.1 requires that the information from the label (including the ANVISA registration number) is put on the IFU, too.

 

[QM Becky]

Happy Monday! You were so helpful before, I hope you can help me again.

We received our ANVISA registration, got our labels taken care of and had our first shipments into Brazil! We then had another customer order and when they received the shipment, told us that our labeling was wrong; specifically the Importer and Technical Representative information.

We understood that the Importer and Technical Rep were the ones associated with our ANVISA registration, so we made our labels standard with that information. The new customer is telling us that we need to add a label showing them as the Importer and the Technical Rep.

My question is: Can the Importer and Technical Rep listed on the product labeling be different than those listed on the official ANVISA registration or do those names vary with each order depending on the customer?

Thank you again for all your help!
Becky