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Medical Devices / Inspections and Audits / Commercial Operations

Brazil’s ANVISA Nixes Medical Device Importation Requirements

Jan. 30, 2018
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Brazil is looking to simplify market entry for foreign manufacturers of medical devices by getting rid of certain import requirements, including mandatory inspections at entry points.

The country’s National Agency for Sanitary Vigilance will no longer require inspections of medical devices and in vitro diagnostic devices at import locations after receiving product clearance, according to newly released guidelines.

Other notable changes to the ANVISA importation guidelines expected to streamline the process include: a 30-day deadline for responding to queries, and exemption from authentication and signature recognition for sponsors using electronic signing and petitioning.

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