WHO NRA assessment tool:
medical devices and
diagnostics
Prepared by Irena Prat
Technical Officer
Essential Medicines and Health Products
2nd WHO Global Forum on Medical Devices
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WHO NRA assessment tool for MD and Dx
Medical devices regulations landscape
In most jurisdictions MD and Dx regulation is relatively new
Harmonization of regulatory requirements among different
jurisdictions is still suboptimal, although improving
Jurisdictions are confronted to the challenging task of ensuring a
good balance between
timely availability of the latest
technology
the need to ensure safety
and performance of MD
Ensuring sustainable good quality of MD requires a strong incountry regulatory system, including pre- and post-market
regulations
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WHO NRA assessment tool for MD and Dx
The GHTF/IMDRF
1993: senior regulatory officials and industry representatives from the EU, USA, Canada,
Japan and Australia established a global consultative partnership aimed at harmonizing
medical device regulatory practices: GHTF
The GHTF was a voluntary group of representatives from national medical device regulatory
authorities and the regulated industry
The purpose of the GHTF was to encourage convergence in regulatory practices related to
ensuring the safety, effectiveness/performance and quality of MD, promoting technological
innovation and facilitating international trade.
The primary way in which this was accomplished was via the publication and dissemination
of harmonized guidance documents on basic regulatory practices.
Guidance principles can be adopted/implemented by NRAs.
As of 2011: GHTF
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WHO NRA assessment tool for MD and Dx
IMDRF International Medical Device Regulators Forum
The GHTF
5 GHTF Study Groups
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Study Group 1 - Premarket Evaluation
Study Group 2 - Post-Market Surveillance/Vigilance
Study Group 3 - Quality Systems
Study Group 4 - Auditing
Study Group 5 - Clinical Safety/Performance
The GHTF regulatory model
• the core and basic elements
• supported by GHTF guidance documents
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WHO NRA assessment tool for MD and Dx
GHTF regulatory model: key subsystems
Risk-based
PM control
These elements are
interrelated and mutually
interdependent.
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WHO NRA assessment tool for MD and Dx
QMS and
RM
process
encompassing life
cycle
PMS
system
Regulatory
process to
periodically
assess
conformity
WHO NRA assessment tool for MD and Dx
In 2009 developed a tool for a
baseline analysis in capacity
building pilot project countries
shall yield an overview of the
NRAs' regulatory functions
and their effectiveness in
ensuring the safety and
performance of diagnostics
A series of indicators assess
the legal base,
responsibilities, processes,
procedures and performance
of the regulatory functions
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WHO NRA assessment tool for MD and Dx
WHO NRA assessment tool for MD and Dx
General information on
Member State and
assessment
National regulatory system
National regulatory authority
for MD and diagnostics (NRA)
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WHO NRA assessment tool for MD and Dx
• Organization
• Legal basis for the
establishment of the regulatory
system for MD and diagnostics
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•
•
•
•
•
•
•
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Legal basis
General information
Institutional development
Organization and structure
Quality management system (QMS)
Funding
Management of human resources
Committees and external experts
Transparency and confidentiality
Independence and impartiality
Infrastructure
Information management systems
Communications activities
NRA assessment tool
MD and diagnostics
regulation overview
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MD and Diagnostics
Premarket
Regulation
•Regulatory oversight
•Inspections
•Evaluations
•Register or list
•Outsourcing
•Guidelines
MD and Diagnostics
Post-Market
Regulation
•Post-market regulation oversight
•Penalties
•Adverse Events
•Field Safety Corrective Actions
•Reciprocal Arrangements
•Batch Release Information
•Laboratory Networks
•Register / list
WHO NRA assessment tool for MD and Dx
NRA assessment tool
Licensing of MD and diagnostics
manufacturers
Licensing of importers, exporters,
wholesalers and distributors of
MD and diagnostics
Control of MD and diagnostics
promotion and advertising
Clinical trials
International cooperation and
harmonization
National reference laboratory for
diagnostics
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WHO NRA assessment tool for MD and Dx
Legal basis
Guidelines
Ethical oversight
Organization and structure
Assessment procedures
Human and other resources
Records and outputs
WHO common assessment tool for medica
products
Medicines, vaccines, medical devices and diagnostics
Common structure: regulatory functions, indicators and
product-specific flexible indicators/sub-indicators
Integration of the harmonized tools into the NRA
assessment database
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WHO NRA assessment tool for MD and Dx
Thank you for your attention
Questions?
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WHO NRA assessment tool for MD and Dx