Medical devices sold in Brazil must be manufactured by a manufacturer with a Quality Management System (QMS) that complies with the Brazilian Standards of Good Manufacturing Control (BGMP) (RDC 665/2022 and RDC 497/2021).
In Brazil, Class III and Class IV manufacturers are required to obtain a BGMP certificate, which is valid for two years.
ANVISA uses a risk-based approach (RDC 217/2018 and RDC 678/2022) to assess whether the manufacturer is required to onsite or off-site audits.
However, manufacturers with QMS that have issued a Medical Device Single Audit Program (MDSAP) certificate will be exempt from field testing.
ANVISA has published an open consultation (Consulta Públican° 1.208, October 16, 2023) to extend the validity of the
BGMP certificate to four years if the manufacturer presents the MDSAP certificate.
The bill will be announced as a resolution to amend RDC 497/2021 and will take effect seven days after it is published in Diário Oficial da União.
Please refer to the file below for details.
If you have any questions about medical device in Brazil,
Please contact us with the below.
info@jnmglobal.net
ra@jnmglobal.net
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