WHO Global Regulatory Model for medical devices and the...
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Working Group on the Development of a Model Regulatory Framework for Medical Devices including Diagnostics | 29-30 September 2015 1 | WHO Global Regulatory Model for medical devices and the use of standards Josée Hansen [email protected]
Transcript of WHO Global Regulatory Model for medical devices and the...
Working Group on the Development of a Model Regulatory Framework for Medical Devices including Diagnostics | 29-30 September 20151 |
WHO Global Regulatory Model for medical devices and the use of
standardsJosée Hansen [email protected]
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Content of presentation
l Context and target audience
l Current status of regulation of medical devices
l WHO Global Model Regulatory Framework for medical devices
l Good regulatory practice
l Standards for medical devices
l Steps
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WHO mandate on regulating medical devices
l WHA 67.20 Regulatory System Strengthening for medical products
… to prioritize support for establishing and strengthening regional and subregional networks of regulatory authorities, as appropriate, including strengthening areas of regulation of health products that are the least developed, such as regulation of medical devices, including diagnostics;
http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R20-en.pdf
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Regulation of medical devices: global
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Regulatory status by income group
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Regulatory status by region
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WHO Global Model
regulatory framework for
medical devices
Including IVDs
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Two steps approach
l Basic level controls and enforcement– Legal framework– Market oversight– Reporting system
l Expanded level controls and enforcement– regulatory controls depending on the priorities of the country
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Regulating medical devices - challengesl Less developed regulatory systems than for vaccines and
medicines, particularly in LIMC’s
l Lack of awareness
l Characteristics of medical devices as a product group
l Regulating in an existing market
l Lack of specialized knowledge and resources to draft and implement medical devices regulations
l Lack of resources
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Good regulatory practices
l Critical elements for regulating medical devices– Political commitment– Legal framework– Implementation plan– Competent authority with enforcement power– Involvement of stakeholders– Transparent and impartial
l Importance of convergence, harmonization, reliance and recognition
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Convergence and harmonization
l Convergence and harmonization– Definition of a medical device– Classification of medical devices– Essential principles of safety and performance– QMS– Standards– …
l Confidence building and Information sharing
l Reliance and recognition
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Reliance and recognition
Source: Swissmedic
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WHO and standards
The Constitution requires WHO…
“…to develop, establish and promote international standards with respect to biological and pharmaceutical products.”
• A long standing activity
• The norms and standards are adopted by Expert Committees
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Expert Committee• Established by World Health Assembly or Executive
Board
• Official Advisory Body to Director-General of WHO
• WHO Expert Committee on Specifications for Pharmaceutical Preparations
• WHO Expert Committee on Biological Standardization
• WHO has no mechanism to develop standards for medical devices
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medicines medical devicesnumber of guidances developed by WHO
• > 75 general QA standards, good practices, guidelines
• 625 test specifications included in the International Pharmacopeia
• > 200 international chemical reference standards
good review practices for medicines and medical devices
blood products< 10 guidelines IVDs as part of PQ
biotherapeutics including vaccines7 general documents for both vaccines and biotherapeutics8 general documents all vaccines5 biotherapeutic specific57 vaccine specific
Standards developed by WHO
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Basic level: legal basis
• The preferred, but non-exclusive, way by which the manufacturer may demonstrate conformity with the Essential Principles is to apply appropriate relevant voluntary international standards. The law should include provisions allowing the regulatory authority to formally recognize such standards for that purpose.
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Expanded level: recognitionRecognize standards
• …Preference should be given to international standards, e.g. those of the International Organization for Standardization (ISO) and the International Electro technical Commission (IEC), regional standards, and the national versions of international standards. It is also important that national standards correspond to the current version of international standards…
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Steps
l Working group developed the Model, starting July 2015
l Public Consultations June and September 2016– http://www.who.int/medical_devices/en/
l October 2016: WHO Model Regulatory Framework for medical devices in the meeting of Expert Committees
l 2016-2017: Regional workshops
l 2017: Training workshops on regulating medical devices
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Thank you very much
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Working Group members
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Mr.AbdullahS.AL-DobaibExecutiveDirectorofRegistrationLicensing,SaudiFood&DrugAuthority
AlanKent,consultant MauraLindaSitanggangDirectorGeneralofPharmaceuticalServicesandMedicalDevicesIndonesia
WoeiJiuangWongDirector,MedicalDevicesBranch,HealthSciencesAuthoritySingapore
TuncayBayrakAssistantHealthExpert,RepublicofTurkeyMinistryofHealth
AgnesKijoManager,MedicalDevices&DiagnosticsRegistration,TanzaniaFDA
ShelleyTangStellarConsultingPTYLTD
NiallMacAleenanMedicalDeviceLead/ClinicalAssessmentandPolicyManagerHealthProductsRegulatoryAuthorityIreland
MichaelGropp NancyShadeedSpecialAdvisor,HealthCanada
KimTrautmanNSF,USA
DonBoyer,consultant
