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Brazil simplifies the transfer of licenses for medtech

In Brazil, it will be possible to transfer licenses for medical products between holders of the relevant Brazilian license from December 25, 2016 on, even if there is no legal or other connection between the license holders.
Lab worker in protective clothing at the microscope.
Medtech in Brazil: Transfer of licenses is simplified.

However, it will only be possible for companies to benefit from this new arrangement under the aegis of Anvisa, the Brazilian Health Surveillance Agency, if the following conditions are met:

  • contractual consent to the transfer from the existing license holder to the new one

  • application to Anvisa for approval of the transfer within 180 days of signature of contract, and approval of the transfer

License transfers are also permitted for products for which license applications have been submitted but for which no license has yet been issued. The transfers do not have to be approved by the manufacturer of the medical product.

Emergo Group: Brazil – new, more flexible regulations for the transfer of licenses

Country Consultation Brazil (various dates in October and November)

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