Modelo Mundial de Marco Regulatorio de la OMS para Dispositivos Médicos, Incluidos Los Dispositivos Médicos de Diagnóstico 'in Vitro'

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Organization, Pan American Health
Formato: Electrónico eBook
Idioma:Español
Publicado: London : Pan American Health Organization (PAHO), 2022.
Temas:
Health.
Health
Santé.
health.
Spanish language materials.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Intro
  • Acronyms and abbreviations
  • Acknowledgements
  • 1 Introduction
  • 1.1 The WHO Global Model Regulatory Framework for Medical Devices including IVDs
  • 1.2 Limitations of the WHO Global Model Regulatory Framework for Medical Devices including IVDs
  • 2. Definition, classification, essential principles and conformity assessment of medical devices
  • 2.1 Definition of medical device and IVD
  • 2.2 Medical devices classification and classification rules
  • 2.3 Essential principles of safety and performance
  • 2.3.1 Clinical evidence for non-IVDs
  • 2.3.2 Assessing conformity to the Essential Principles
  • 2.4 Special considerations for regulation of IVDs
  • 2.4.1 Classification of IVDs
  • 2.4.2 Essential Principles of safety and performance for IVDs
  • 2.4.3 Clinical evidence for IVDs
  • 2.4.4 Lot verification testing of IVDs
  • 3. Enabling conditions for effective regulation of medical devices
  • 3.1 Legal requirements
  • 3.2 Gap analysis of existing controls
  • 3.3 Implementation plan
  • 3.4 Monitoring implementation
  • 3.5 Regulatory authority
  • 3.6 Funding the regulatory system
  • 3.7 Conflict of interest and impartiality
  • 3.8 Regulatory competencies and resources
  • 4. Establishing a stepwise approach to regulating medical devices
  • 4.1 Stepwise approach
  • 4.1.1 Reliance and recognition
  • 4.1.1.1 National responsibilities
  • 4.1.1.2 International collaboration
  • 4.2 Basic-level controls and their enforcement
  • 4.2.1 Publish law, including definition, and regulations with transition period
  • 4.2.1.1 Establish medical device classification for regulatory purposes
  • 4.2.1.2 Establish Essential Principles of safety and performance
  • 4.2.2 Basic-level controls and enforcement
  • premarket
  • 4.2.2.1 Establish a basis for reliance and recognition
  • 4.2.2.2 Establish requirements for declaration of conformity
  • 4.2.2.3 Establish requirement for manufacturers to have a QMS
  • 4.2.2.4 Establish requirements for labels and labelling
  • 4.2.2.5 Prohibit deceptive, misleading and false advertising
  • 4.2.2.6 Establish provisions for exceptional premarket situations
  • 4.2.3 Basic-level controls and enforcement
  • placing on the market
  • 4.2.3.1 Registration of establishments
  • 4.2.3.2 Listing of medical devices
  • 4.2.3.3 Import controls
  • 4.2.4 Basic-level controls
  • postmarket
  • 4.2.4.1 Establish a system for vigilance reporting
  • 4.2.4.2 Require mandatory notification by the manufacturer of FSCA
  • 4.2.4.3 Establish a procedure to withdraw unsafe medical devices from the market
  • 4.2.4.4 Establish procedure to issue safety alerts to users
  • 4.2.4.5 Undertake market surveillance
  • 4.3 Expanded-level controls
  • 4.3.1 Expanded-level controls
  • premarket
  • 4.3.1.1 Create oversight of clinical investigations
  • 4.3.1.2 Appoint and have oversight of CAB
  • 4.3.1.3 Recognition of standards
  • 4.3.1.4 Adopt a medical device nomenclature system

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