WHO Medical Device Regulations
Global overview and guiding principles
The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities. For example, legal terms and their meanings are sometimes non-uniform even within one regulatory system. In an attempt to make this complex subject easier to grasp, this Guide presents a common framework that integrates the regulatory systems of the five countries or regions with the most advanced medical device regulations. Non-technical language, graphics, tables and memory anchors are used to present an overview of medical device safety issues and regulatory philosophy.
The Guide begins by explaining how safety is a risk management issue, and how optimum safety and performance require cooperation among all who are involved in the life span of a medical device. The critical elements of medical device regulations are illustrated using a common framework for regulatory development; as well as the current regulatory tools of the Global Harmonization Task Force (GHTF) and all the key documents it has issued in the past three years.
Understanding the different phases in the life span of a medical device and the common framework are first steps to successful harmonization and simplification worldwide.
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Contents
Note on the definition of medical
devices
Chapter 2. Medical device
safety
2.1 Medical device safety and risk
management
2.2 Effectiveness/performance of
medical devices
2.3 Phases in the life span of a
medical device
2.4 Participants in ensuring the
safety of medical devices
2.5 The role of each
participant/stakeholder
2.6 Shared responsibility for
medical device safety and performance
Chapter 3. Governmental regulation
of medical devices
3.1 Critical elements for
regulatory attention
3.2 Stages of regulatory control
3.3 A common framework for medical
device regulations
3.4 Regulatory tools and general
requirements
3.4.2 Vendor establishment
control
3.4.3 Post-market
surveillance/vigilance
3.4.4 Quality system
requirements
Chapter 4. Global Harmonization
Task Force (GHTF)
4.2 Scope of the four GHTF study
groups
4.4 Final documents from the
GHTF
4.5 Global Medical Device
Nomenclature (GMDN)
5.3 Voluntary and mandatory
standards
5.4 Standards development
process
5.5 Conformity assessment with
standards
5.6 National and international
standards systems
5.7 Identification of
standards
5.8 Current trends in the use of
standards in medical device regulations
Chapter 6. Optimizing the use of
regulatory resources
6.1 Increasing knowledge of the
medical device sector
6.2 Establishing basic regulatory
programmes
6.3 Drafting a comprehensive policy
or guideline on medical device management
6.3.1 Advantages of a national
policy
6.3.2 Classification of medical
devices
6.3.3 Medical device product
control
6.3.4 Product representation control
6.3.5 Vendor establishment
control
6.3.6 The control of home-use,
refurbished, and donated devices
6.3.7 The re-use of medical devices
that are labelled “for single use”
6.3.8 Post-market
surveillance
6.3.9 Recognition and use of
established national or international standards
6.4 Promoting compliance and
cooperation
6.5 Setting priorities for
regulatory programme development
6.6 Cautions in interpreting
medical device “export certificates”
Chapter 7. Priorities on the
international agenda
Annex 1. Resources for medical
device information
Annex 2. Final documents of the
GHTF as they relate to the Common Regulatory Framework
Annex 3. Relationship between
ISO9001:1994 and ISO13485:1996
Annex 4. Aide-mémoire for National
Medical Device Administrations
WHO Medical Device Regulations:
