FDAnews Device Daily Bulletin
Quality / Medical Devices

Brazil Revamps GMP Inspections to Improve Access to New Technologies

Oct. 6, 2017
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Brazil’s National Agency for Sanitary Surveillance is streamlining its process for good manufacturing practice certification to allow faster access to new technologies.

ANVISA will conduct risk assessments for international devices including reviews of technical documents rather than on-site GMP inspections, depending on the level of risk identified. The change will mean greater flexibility in determining risk for certain Class III or Class IV devices.

The agency plans to consider the manufacturing stage of the device, the technology involved, additional control factors, and how much value an on-site manufacturing inspection would add.

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