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Medical Device License Transfer in Brazil

apuigvert

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#1
Hello all, I hope you can help me with a doubt regarding License transfers in Brazil, particularly for REGISTRO. Given the following situation:

1. Let’s say that a Brazilian importer (Company A) has registered a product with ANVISA, manufactured by a foreign manufacturer (Company X).
2. The product is a class III medical device, so they have passed a GMP audit to the manufacturer’s facility. This means that Company A also holds a GMP Certificate, for Company X’s QMS.
3. The product is medical electrical, so Company A also has an INMETRO Certificate under their name.
4. Company A wants to transfer the license to Company B, another Brazilian importer, for commercial reasons (not “operaçoes societarias”). Their AFE, LF and their own GMP are aligned.

I have the following questions:
a. Company A and Company B need to submit to ANVISA evidence of the commercial operation over the license: can this be done via an agreement, with no value? Should there be a (proforma) invoice included?

b. What should be done, if any, about the GMP certificate that Company A has been granted with, considering that it cannot be transferred to Company B? Does Company B need to request a new audit to Company X’s GMP, with the associated fees?

c. What should be done, if any, about the Inmetro certificate that has been granted under the name of Company A, considering that it cannot be transferred to Company B? Does Company B need to request a new Certificate or some sort of extension of the existing Certificate?
 
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Marcelo

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#2
a. Company A and Company B need to submit to ANVISA evidence of the commercial operation over the license: can this be done via an agreement, with no value? Should there be a (proforma) invoice included?
It shall be a "instrumento contratual de transferência de ativos ou de um conjunto de ativos", a contract, as defined in the Annex I of RDC 102/2016. Please note that at first you do not need to send the contractual instrument, only refer to it. ANVISA can ask for a copy if needed.

b. What should be done, if any, about the GMP certificate that Company A has been granted with, considering that it cannot be transferred to Company B? Does Company B need to request a new audit to Company X’s GMP, with the associated fees?
Company B needs to request an update of the CBPF data, if all technical conditions are the same. This is defined in Section II of RDC 102.


c. What should be done, if any, about the Inmetro certificate that has been granted under the name of Company A, considering that it cannot be transferred to Company B? Does Company B need to request a new Certificate or some sort of extension of the existing Certificate?
Company B needs to request a new certificate (meaning, go thru the process again).
 
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