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

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
 
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.
 
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