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Brazilian Regulator ANVISA Amends Medical Device Import Law

Brazil’s medical device regulator ANVISA has amended its medical device import policy to include those with manufacture dates that precede their registration dates.

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August 30, 2023

Brazil’s medical device regulator ANVISA has issued RDC No. 810/2023 (link in Portuguese) to amend Article 60 of RDC No. 751/2022: Notification and Registration of Medical Devices (link in Portuguese). The amendment took effect August 18, 2023.

Medical devices may now be imported into Brazil if manufacture date precedes registration date

The amended resolution now allows the importation of medical devices and their accessories if the date of manufacturing precedes the date of the notification or registration. The caveat is that the period between the device’s manufacturing date and registration date must not exceed five years and that such products must strictly comply with the conditions of approval with ANVISA. This applies to import processes filed with ANVISA as of June 18, 2023.

Brazil’s Import Manual updated to include this amendment

Brazil’s Import Manual, Manual de Importação de Dispositivo Médico, (link in Portuguese) was also updated to reflect this amendment and to include discussions on the data for regularization of customized medical devices and devices containing tissues or fluids of ruminant animals.


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