Brazil Blog Posts

ANVISA Changing Brazilian Market Pathway for Low-risk Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA plans to replace the cadastro registration route for Class I medical devices with a notification pathway based on IMDRF recommendations.
  • Stakeholders will have 60 days to submit comments on the proposed change once ANVISA publishes its official public consultation.
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Changes to Brazil ANATEL Certification Requirements for Wireless Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • ANATEL certification for wireless medical devices is now required for ANVISA registration in Brazil.
  • Previously, ANATEL certification was required for commercialization but not registration.
  • Manufacturers that have already started their ANVISA registration projects will need to secure ANATEL certification before submitting registration applications.
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MDSAP Certification Route Extended to Brazilian, South American Medical Device Companies

EMERGO SUMMARY OF KEY POINTS:

  • Brazilian regulators now allow domestic manufacturers to apply for quality system certification under the Medical Device Single Audit Program (MDSAP).
  • Previously, ANVISA’s position was to recognize MDSAP certification only for foreign manufacturers.
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Brazilian ANVISA Clarifies Local, Federal Level Medical Device Oversight Responsibilities

EMERGO SUMMARY OF KEY POINTS:

  • ANVISA has formally mapped out medical device regulatory responsibilities at its federal, state-level and local branches.
  • Under RDC 215/2018, ANVISA oversight responsibilities and structures currently in place are mostly kept as is.
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Brazil’s ANVISA Doubles Validity Timeframes for High-Risk Medical Devices and IVDs

EMERGO SUMMARY OF KEY POINTS:

  • ANVISA has extended Class III and IV medical device and IVD registration validity times from five to 10 years.
  • These changes have already gone into effect in Brazil.
  • ANVISA registrants that have already obtained registration renewals will automatically qualify for the extended validity timeframe.
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Brazil’s ANVISA Streamlines Medical Device Importation Processes

EMERGO SUMMARY OF KEY POINTS:

  • 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.
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Brazilian Regulators Establish Criteria for Marketing of Unregistered Medical Devices

EMERGO KEY POINTS:

  • New Brazilian regulations list criteria for importing unregistered medical devices and health products into the country to address public health issues.
  • Qualifying devices and products must be requested by the Brazilian Ministry of Health; requests are then reviewed by ANVISA.
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Brazil’s ANVISA Proposing Easier Market Pathway for Low-risk Medical Devices and IVDs

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA plans to replace cadastro registration requirements for Class I medical devices and IVDs with a notification system for faster market access.
  • Class I devices undergoing notification instead of cadastro review would bypass technical analysis.
  • Additional public consultations and regulations will need to be published before ANVISA’s notification system comes into force.
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ANVISA Provides More Details on New Brazilian GMP Inspection Regime

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA has published a new regulation to clarify changes to its Brazil GMP inspection and certification process.
  • The regulation, RDC 183/2017, explains which documents are required for BGMP certification as well as which types of establishments that must obtain BGMP certification in Brazil.
  • Applicants that submitted inspection requests before the new BGMP certification process was announced will have 60 days to file amendments to ANVISA to qualify for the new approach.
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ANVISA Officially Publishes Brazilian GMP Certification Process Changes

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA has published updated BGMP certification rules allowing for desktop reviews instead of on-site inspections.
  • The new BGMP requirements apply to Class III and IV device registrants able to provide adequate technical documentation for review.
  • A Normative Instruction from ANVISA is anticipated that will provide additional details on how the new BGMP certification process will work.
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