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Brazil’s ANVISA Streamlines Medical Device Importation Processes

A new ANVISA resolution has simplified medical device importation requirements for Brazil.
Imported devices no longer have to undergo inspections at Brazilian points of entry.
Additional changes to simplify ANVISA importation requirements are anticipated in the near future.

Among other changes, ANVISA Resolution RDC 208/2018 (link in Portuguese) removes requirements that devices imported into Brazil must undergo inspection at sites where they receive product clearance, which should result in faster time to market for affected importers.

RDC 208/2018: Impact on medical device importers
Other important changes in the new resolution include:

Changing deadlines for responses to importation queries to 30 days
Labeling requirements that now differentiate information according to product class
Device imports no longer require authentication and signature recognition following implementation of electronic signing and petitioning processes
Importers must no longer link MERCOSUR Common Nomenclature (NCM) to particular procedures.

Passarini Regulatory Affairs

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