Brazil Blog Posts

Special Report: Brazil’s ANVISA Improves Medical Device Registration Review Timeframes for 2018

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA reports higher volumes of medical device market application submissions for the first half of 2018.
  • Increased submission volumes are mostly for lower-risk medical devices and IVDs.
  • ANVISA was able to respond to most cadastro and registro market applicants within a 90-day time frame, according to the six-month results.
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Brazilian Regulators Introduce UDI Requirements for Some High-risk Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Brazilian regulators are introducing UDI requirements for high-risk devices including stents and implants.
  • ANVISA’s new RDC 232/2018 brings UDI to the Brazilian market for the first time.
  • Implementation of the regulation as well as a UDI database, the RNI System, is expected in 2020.
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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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