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

[jpaul75]

Hello Marcelo Antunes,

thank you very much for administering this thread and sharing your knowledge and experience, very informative.

We would like to sell our class I medical device (CE) in Brazil, and are considering the possibility of opening a brazilian firm that would be the notification holder, importer and distributor.

But in order for this option to be viable the firm's structure would have to be as lean as possible, so if you wouldn't mind I would like to pose the following questions (sorry if some of them may seem a little absurd):

- company would be created under the new "sociedade ltda unipessoal" format created by the recent MP 881/2019, might this be a problem for obtaining Anvisa's AFE?

- for the related activities (importing and distribution of medical devices), does the "responsavel tecnico" need to be part of any given professional order? If so, which?

- "responsavel legal", "responsavel tecnico" and "gestor de seguranca" could be the same individual?

- would the company need to have any given minimum human resources structure? For example, would it be a problem (for AFE purposes) in case it had no employees at all, and Anvisa's inspector(s) were received by the very same individual who is the firm owner, legal and technical representative?

Thanks in advance

 

[jpaul75]

Not sure whether this thread is still active, but will post the answers to some of my own questions in case someone in the future use the forum's search tool.

According to so.com.br/saibamais_registroanvisa.asp (sorry but being a new member the system doesn't allow me to post live links), for medical devices a standard university degree of any profession is enough, and I would suppose recognized by its respective professional order.

Regarding "responsavel legal" and "responsavel tecnico" being the same person, have found this: portal.anvisa.gov.br/registros-e-autorizacoes/cadastramento/responsavel-tecnico-e-legal (#6), so would not be an issue.

Still haven't found info regarding minimum company structure, would appreciate if anyone could chime in and share past experiences or point me out to any specific regulation.

 

[kdawg]

bump

 

[Marc]

@kdawg and others - FYI: Marcelo has moved on.

 

[kys123]

I apologize for reviving a 2 year old topic, but I figured that since it's a sticky I won't be causing too much disturbance and this knowledge might be very useful for other people.

- company would be created under the new "sociedade ltda unipessoal" format created by the recent MP 881/2019, might this be a problem for obtaining Anvisa's AFE?

No, the legal format of the company does not pose any problems for receiving an AFE.
However, said company MUST include in its Economic Activities (CNAEs) one or more activities that are considered subject to sanitary surveillance (such as CNAE 46.45-1-01 - Wholesale of instruments and materials for medical, surgical, hospital and laboratory use), in order to be audited by sanitary inspectors regarding RDC 665/22 (current GMP/GDP law) and then submit the audit report and/or sanitary certification to Anvisa in order to be granted an AFE for that activity.

For added clarification, regarding AFE purposes, Anvisa does not do hands-on auditing.
The audit will usually be conducted by the cities' own sanitary inspectors if you are based near/in a big or capital city.
If the company is located in a "remote" area OR if your AFE includes manufacturing, the company will usually be audited by state auditors, which in my experience are more knowledgeable/better trained.

- for the related activities (importing and distribution of medical devices), does the "responsavel tecnico" need to be part of any given professional order? If so, which?

Yes, the responsável técnico does need to be part of a professional order.
Anvisa does not require any specific orders, however, the orders themselves are responsible for policing technical responsibilities (e.g. the engineering order will not allow a mechanical engineer to be the technical responsible for a company that is involved in importing pharmaceutical products. This will also hugely depend on the company CNAEs and will vary by state).

- "responsavel legal", "responsavel tecnico" and "gestor de seguranca" could be the same individual?

Yes.

- would the company need to have any given minimum human resources structure? For example, would it be a problem (for AFE purposes) in case it had no employees at all, and Anvisa's inspector(s) were received by the very same individual who is the firm owner, legal and technical representative?

If you had no employees at all, I believe it would be impossible to demonstrate the company can comply to the RDC 665/22 Good Distribution Practices, even if the company is very small scale, since only one person would be responsible for performing, verifying and approving their own work.
That being said, the smallest importer/distributor I've seen pass a municipal audit was 2 people, but your mileage may vary.

 

[Pola]

Hello everyone,
I would like to ask if any of you can recommend a reliable company offering the Brazilian Holder Registration service. I found that someone recommended Emergo, Mandala and Azara. Can you recommend any other company besides the ones mentioned above?

Thank you in advance for your help

 

[kys123]

Hello everyone,
I would like to ask if any of you can recommend a reliable company offering the Brazilian Holder Registration service. I found that someone recommended Emergo, Mandala and Azara. Can you recommend any other company besides the ones mentioned above?

Thank you in advance for your help

Hey Pola,

I currently work at a company that acts as a registration holder.
Some of the other big names like Emergo are Vera Rosas and Passarini. Personally, I had never heard about Mandala or Azara before.

If you have any questions please feel free to message me.

 

[Pola]

Hey Pola,

I currently work at a company that acts as a registration holder.
Some of the other big names like Emergo are Vera Rosas and Passarini. Personally, I had never heard about Mandala or Azara before.

If you have any questions please feel free to message me.

Thank you for recommedations.