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

[Paramedic]

Re: Medical Device Registration Process in Brazil - Anvisa

Hallo Nikolas,
the Brazilian regulation for GMP-audit is ANVISA RDC 59/00. It is quite similar to FDA regulation 21CFR820, but still has some deviations.

 

[Marcelo]

Re: Medical Device Registration Process in Brazil - Anvisa

the Brazilian regulation for GMP-audit is ANVISA RDC 59/00. It is quite similar to FDA regulation 21CFR820, but still has some deviations.

I've discovered the real problem sometime ago...

Th brazilian GMP is in fact a mix of the 1978 version of 21CFR820 and the 1996 version.

That's why it has some weird, too detailed requirements (particularly related to cleanliness).

 

[Marcelo]

Re: Medical Device Registration Process in Brazil - Anvisa

I have question about using B-GMP certificate. A company in China has got B-GMP certificate and, as legal manufacturer, got registrations of products by local representative. At the same time, A's factory also manufacture similar products for B company in USA. But the legal manufacturer of these products is B company. If A's local representative also help B company apply and hold registrations of these products, does B company need to apply new B-GMP certificate? I think B company should be able to directly use A's GMP certificate. How do you think?

Very late answer (been away for some time, sorry :-().

The certificate is not given to the original manufacturer, but to the brazilian registration holder. If the the same original company produces the device, and the same BHR register the device in Brazil, I would say that he can use the same certificate.

 

[Marcelo]

Re: Medical Device Registration Process in Brazil - Anvisa

What I am not clear about is whether we still need INMETRO certification if our Class II device is not in the IN 02/11 list. Especially since we are our now 4 months outside the 2 year window for our IEC 60601-1 test report.

Do you know if INMETRO is very strict about the 2 year time frame for test reports? Does having a CB certificate or CSA/UL certification (with quarterly inspections) help in avoiding complete re-testing?

Inmetro certification is still required by products under cadastre. In fact it's one of the justification Anvisa have said to recude the burden on some low risk devices.

INMETRO is strict about it, but I've seen some certification bodies accept some reports with some months old. This is not right, but can happen. Not what I would expect, thought.

Inmetro certification does not accept CB or CSA/UL certification.

Complete retesting is required anyway.

 

[Margret]

Re: Medical Device Registration Process in Brazil - Anvisa

Hi,
I am working on “cadastre” and wondered what exactly is mandatory for these products. At first it seemed pretty easy but I ended up confused about the declaration (Declaracao do Responsável Legal e Técnico) in section 5 of the form. I sign that the product is GMP compliant and compliant with RDC-56/01. From what I understood from RDC-56/01 is that clinical evaluation and an appropriate risk management are necessary.
Does that mean that I conduct a clinical evaluation and risk management and hold the documents but do not submit it to ANVISA?
Is 14971:2009 mandatory?
Is RDC-67/09 (technical surveillance) applicable here?
Thank you!

 

[Jayanti]

Re: Medical Device Registration Process in Brazil - Anvisa

A question: If a medical device has ANVISA registration which expires in 2013. Would INMETRO marking be required for such a product?

 

[Marcelo]

Re: Medical Device Registration Process in Brazil - Anvisa

Hi,
I am working on “cadastre” and wondered what exactly is mandatory for these products. At first it seemed pretty easy but I ended up confused about the declaration (Declaracao do Responsável Legal e Técnico) in section 5 of the form. I sign that the product is GMP compliant and compliant with RDC-56/01. From what I understood from RDC-56/01 is that clinical evaluation and an appropriate risk management are necessary.
Does that mean that I conduct a clinical evaluation and risk management and hold the documents but do not submit it to ANVISA?
Is 14971:2009 mandatory?
Is RDC-67/09 (technical surveillance) applicable here?
Thank you!

Hi, and sorry for the late reply.

The declaration is the legally binding document in which you claim that your device is in confirmity with the regulations - similar to the declaration of conformity for CE Marking.

RDC 56 details the essential principles of safety and effectiveness - again, almost the same as Annex 1 of the medical devices dorective in Europe. As a manufacturer you DO have to comply with RDC 56 in the way you do (and the only correct way, really, is thru risk management). ISO 14971 is not mandatory to all devices, but Anvisa will expect you use it, and this makes it "semi-mandatory" . And yes, you do have to do your homework during design and development, but Anvisa does not want that you send them in the cadastre...you have to hold them and only if Anvisa requires you have to show them.

RDC 67 is applicable to all medical devices manufacturers, so yes, it's applicable in your case.

 

[Marcelo]

Re: Medical Device Registration Process in Brazil - Anvisa

If a medical device has ANVISA registration which expires in 2013. Would INMETRO marking be required for such a product?

If it's a medical electrical equipment, yes.

Update: Sorry, I answered automatically and didn't really understand you question, I think.

The INmetro certification will be required when you revalidate te registration, but not before.

 

[Marcelo]

Re: Medical Device Registration Process in Brazil - Anvisa

Also take care with one point - you can only make a petition for revalisation in the first 6 months of the last year of validity of the registration (meaning , the 9th semester). And you have to have the Inmetro certificate "before" you submit the revalidation, otherwise it will be automatically denied.

So, if your device registration ends in January 2013, you need to submit between january and July 2012, and then you have to get the Inmetro certificate before that.

You should talk to the brazilian registration holder of your device registration, he should've told you about that.

 

[Mondo 22]

Re: Medical Device Registration Process in Brazil - Anvisa

All,

Great thread although I’m slightly confused!

We currently manufacture MEE products and are classified as IIb products in the EU (Class III in Brazil)

I am aware of the requirements for an ANVISA inspection but could you clarify something.

Is an ANVISA inspection a Quality System inspection and INMETRO part the Product Registration?

I suppose what im asking is how do i go about registering this product?
How long does it take?
How much does it cost?

Any help would be much appreciated

Thanks and Regards,
Ray