ORBIS Compliance

Brazil's 2024-2027 Strategic Health Regulation Plan

Published /Brazil

The Strategic Plan for 2024-2027

The Strategic Plan for 2024-2027 outlines priorities and objectives to address present and future challenges in Brazil's health regulation landscape.

Strategic Objectives:

  1. Safe Access: Ensure safe access to essential health products and services for the population.
  2. Technology Development: Contribute to the development of new health technologies within Brazil.
  3. Crisis Response: Anticipate and respond effectively to health crises and emergencies.
  4. Information Empowerment: Empower individuals with health information to make informed choices.
  5. International Recognition: Attain recognition as an international authority in health standards.
  6. Data Utilization: Promote intensive use of health data for informed decision-making.
  7. Workforce Development: Develop a skilled workforce for future health challenges.

Mission:

Promote and protect the health of the Brazilian population through scientific excellence in regulating health products, services, and environments. Support access, reduce risks, and contribute to the country's development in collaboration with the Unified Health System.

Vision:

To become an innovative and trusted health authority serving the entire society.

Implementation Approach:

  • Collaborative Governance: Requires engagement beyond internal implementation, involving Federal, State, and Municipal Governments, regulated sectors, academia, and society.
  • Key Partnerships: Collaboration with various organizations essential for achieving desired outcomes.

Impact Assessment:

  • Approval Impact: Streamlined approval processes ensure safe access to essential health products and services.
  • Spectrum Impact: While not directly addressing spectrum, the plan's focus on technology development may indirectly impact spectrum usage through innovation in health technologies.
  • Importer Impact: Importers may need to comply with updated regulations to ensure safe access to health products and services.
  • Format and Requirements: Clear objectives provide guidance for regulatory standards and workforce development.
  • Exemptions: Specific exemptions not outlined, but compliance with health standards necessary for product approval.
  • Timeline and Implementation: Strategic Plan spans 2024-2027, with milestones and actions to be implemented progressively.
  • Market Access Requirements Impacted: Emphasis on safety and technology development may impact market access, promoting compliance with health regulations and standards.

Link to Source - https://www.gov.br/anvisa/pt-br/acessoainformacao/acoeseprogramas/planejamento-estrategico/2024-2027/plano-estrategico

Brazil Quick Facts

Regulatory AgencyANATEL (Agência Nacional de Telecomunicações)
Certification TypeMandatory
License ValidityTechnical compliance certificate: 2 to 3 years
Application LanguagePortuguese
Legal License HolderRequired
In-country Testing RequirementRequires testing

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