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

[tibon74]

Hello,

Have Someone any news about the public consultation CP50 allowing to sumbit registration requests only with a request of ANVISA inspection?

Thank you!
Taieb

 

[globalmed]

Marcelo,

My partner and I are trying to bring US medical device implants into Brazil. I am in the US and he is based in Brazil. What we would like to do is take the US product that is FDA approved and being sold in the US and Europe and private label it (just put our logos on the implants, instruments, cases, and literature) to sell in South America. I was told that we can't do this as it has to be the same exact product that is FDA approved and can't be re-labeled. Can we do this or are we just the representative for the manufacturer in the US?

Thank you for your help,

Steven

 

[Marcelo]

By Brazilian regulations, the registration holder in Brazil is fully responsible for the devices, so no, you cannot be the "representative for the manufacturer in the US".

You can also label the device the way you want. However, you need to have the information that the design information that proves the safety end efficacy of the device, because it?s part of the registration process and you will need to send those to ANVISA (or keep them, depending on the type of device).

 

[tibon74]

How much time it take for the renewal of instrument registration (cadastre) and when should we submit the renewal request?

The time for the renewal depends on the line at ANVISA. For materials it?s more than one year, for equipment it?s some 4 or 5 months.

Submission should be in the window of the first 6 months of the last year of validity.

Just a reminder (and I didn?t mention it here before anyway) - there?s a new public consultation for the revision of RDC 24 which will revise the cadastro process, and one of the changes is the removal of the need to revalidate the cadastro.

 

[Marcelo]

Just a correction, just checked the ANVISA website and the cadastro for equipment is 8 months now (the same as registro).

 

[tibon74]

Marcelo,

thank you! I know for CP24. do you have any news about it ?
what are the changes for example?

 

[Marcelo]

Basically:

- new documents to be provided for imported medical devices

- removal of need of renewal, but for devices with INMETRO certification the cadastro will be tied to the certificate (a lot more importance to certification then)

- registration holders have to keep a very detailed technical dossiers for the device

 

[tibon74]

thanks!
Which documents sould we provide for imported class I and II?
and for medical device already approved?
what do you mean by "very detailed technical dossiers"?

 

[Marcelo]

Forgot to mention that all classes I and II will be cadastro because the exemption list will also be revoked.

Which documents sould we provide for imported class I and II?
and for medical device already approved?
what do you mean by "very detailed technical dossiers"?

You would need to take a look at the attached CP in portuguese because I do not have it in english at the moment.

Documents for imported device are in Article 4.

The dossier is in Annex I.

For medical devices already approved, they will need to follow the new rules when the CP is published as a RDC>

 

[tibon74]

thank you !
"caso o produto ou parte dele seja produzido por terceiro, rela??o informando raz?o social e endere?o completo da(s) empresa(s) envolvida(s), e etapas correspondentes no processo de fabrica??o". we will need to describe the manufacturing and provide the list of subcontractor?
What does "c?pia do Certificado de Conformidade emitido no ?mbito do Sistema Brasileiro de Avalia??o da Conformidade (SBAC), aplic?vel apenas para os produtos m?dicos com certifica??o compuls?ria, relacionados pela ANVISA em regulamentos espec?ficos;" mean ?
thanks again !