ANVISA, Brazil's medical device regulator, issued RDC No. 810/2023 to amend Article 60 of RDC No. 751/2022: Declaration and Registration of Medical Devices, the amendment effective August 18, 2023.
The revised content allows the import of medical devices and accessories if the manufacturing date is earlier than the date of declaration or registration.
Note that the period between the manufacturing date and the registration date cannot exceed 5 years and the product must strictly comply with the approval conditions of ANVISA.
In addition, the Brazilian import manual has also been updated to include the amendment.
Please refer to the link below for details.
< ANVISA RDC No. 810/2023 >
RESOLUÇÃO - RDC Nº 810, DE 17 DE AGOSTO DE 2023 - RESOLUÇÃO - RDC Nº 810, DE 17 DE AGOSTO DE 2023 - DOU - Imprensa Naciona
Portal da Imprensa Nacional do Brasil. Diário Oficial da União.
www.in.gov.br
< import manual >
Manual de Importação de Dispositivos Médicos - Versão 2.7 — Agência Nacional de Vigilância Sanitária - Anvisa
Atualizado em 22/09/2023 11h23 Manual_dispositivo_médico_versão_final 2.7.pdf — 1532 KB
www.gov.br
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