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Brazil ANVISA & LGPD - Processing of Health Data and Medical Device Regulation (2026)

ANVISA regulates medical devices and SaMD under RDC 751/2022 while LGPD (Law 13.709/2018) imposes strict rules for processing sensitive health data.…

What Brazil ANVISA & LGPD - Processing of Health Data and Medical Device Regulation (2026) requires

ANVISA regulates medical devices and SaMD under RDC 751/2022 while LGPD (Law 13.709/2018) imposes strict rules for processing sensitive health data. Requirements include explicit consent or legal basis, data minimisation, security measures, breach notification within 2 working days, and accountability for controllers/processors handling health information.

Pillar: Data Protection & Privacy · Authority: ANVISA & National Data Protection Authority (ANPD) · Version: 1.0.0 · Last updated:

Primary source: https://www.gov.br/anvisa/pt-br

SHA-256 integrity: e1e72c208216625c0b0faece7775798578d3fcfb37b30dc5036028de1d93fdb5

Primary Citations — 5 traced to source

  • RDC 751/2022 - ANVISA Regulation on Medical Devices and SaMD
  • Law 13.709/2018 - General Data Protection Law (LGPD)

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