WHO Medical device regulations - global overview and guiding principles (2003)

Governments need to put in place policies that will address all elements related to medical devices, ranging from access to high quality, affordable products, appropriate use and disposal. The health technology life cycle illustrates the policy process that needs to be in place. However, policies will be unsuccessful unless they are translated into national regulations that are enforced by legislation and correlating sanctions, and that form an integral part of the overall national health system.

The term “medical devices” includes everything from highly sophisticated computerized medical equipment down to simple wooden tongue depressors. The intended primary mode of action of a medical device on the human body, in contrast with that of medicinal products, is not metabolic, immunological, or pharmacological.

Several different international classification systems for medical devices are still in use in the world today. The World Health Organization, with its partners, is working towards achieving harmonization in medical device nomenclature, which will have a significant impact on patient safety This is particularly important to be able to identify adverse incident reports and recalls.

The Global Harmonization Task Force has proposed the following harmonized definition for medical devices. “Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury
• investigationInvestigation Purpose of all investigation is to reveal the unvarnished truth. The constitutional courts are duty bound to ensure that the truth is revealed., replacement, modification, or support of the anatomy or of a physiological process
• supporting or sustaining life
• control of conception
• disinfection of medical devices
• providing information for medical purposes by means of in vitro examination of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

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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