Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hello All,

We would like to know if anybody has information about how the license transfer form Medical Device class IV works with Anvisa. We have a class IV products registered with one distributor in Brazil but we would like to transfer just one product from the same license to another distributor. Can that be done?

We will appreciate any information.

Yes it can, following RDC nº 102/2016, which details the requirements for license transfer.

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Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil
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Original Message:
Sent: 21-Sep-2018 10:51
From: Anonymous Member
Subject: Brazil Regulation-Tranfer license Anvisa

This message was posted by a user wishing to remain anonymous

​Hello All,

We would like to know if anybody has information about how the license transfer form Medical Device class IV works with Anvisa. We have a class IV products registered with one distributor in Brazil but we would like to transfer just one product from the same license to another distributor. Can that be done?

We will appreciate any information.