A Model Regulatory Program For Medical Devices: An International Guide

Abstract

It is a truism that medical technology, in varying degrees, has permeated health care delivery systems throughout the world. Major advances after World War II in electronics, computerization, biomaterials and other scientific and technical fields led to the development of life-saving, life-supporting and other critical devices at a staggering pace. Indeed, more than 50,000 different types of devices are now being distributed in world trade. This technological revolution, which has saved lives and improved the quality of life for millions of people, continues today and should continue on into the foreseeable future. This post-war phenomenon theoretically knows no geographic boundaries. Globally, it is estimated that the market for medical devices is growing steadily at 7 percent (1993 estimate) compared to a 1.2 percent growth rate for the world economy for the same time period. Expansion of the world market is the particular result of rapidly-emerging markets in Asia and regions in Latin America. In these areas alone, the rate of market growth is roughly three to four times higher than for the United States, Japan and Europe. Nevertheless, the availability of innovative, safe and clinically effective medical devices to the world’s population is not universal. This variability in access to even basic medical technologies exists from continent to continent, country to country, locale to locale and population group to population group. At the same time, the types and levels of regulatory controls to safeguard consumers from unsafe and ineffective medical devices, if they exist at all, also vary significantly around the world. While efforts are presently underway among some industrialized nations with medical device regulatory systems to harmonize their requirements to spur global competitiveness and provide for better husbandry of scarce regulatory resources, many if not most of the world’s developing countries have no regulatory requirements for medical devices, whether imported or produced domestically, to protect their citizens. This document provides a framework to assist Member States in establishing regulatory programs for medical devices. Because of the differences in socioeconomic conditions that exist among countries that may pursue device regulatory programs and their infrastructural capacities to implement them, the model program contained in this document is, by necessity, relatively general. It is also designed in a modular format to give interested nations the flexibility to adapt those elements of the model that best serve their individual needs and which they are best able to support...