Medical Device Regulations – Global Overview and Guiding Principles

The term medical devices covers a vast range of equipment, from simple tongue depressors to haemodialysis machines. Like medicines and other health technologies, they are essential for patient care – at the bedside, at the rural health clinic or at the large, specialized hospital. Medical devices also cost governments a substantial amount of money. In 2000, the estimated one and a half million different medical devices available on the market represented over US$145 billion. With innovation and the rapid advancement of technologies, medical devices are currently one of the fastest growing industries, and the global market figure for 2006 is expected to exceed US$260 billion.

Yet many countries lack access to high-quality devices and equipment that are appropriate for their specific epidemiological needs. This is particularly true in developing countries, where health technology assessments are rare and where little regulatory controls exist to prevent the importation or use of substandard devices. With the vast majority of devices in developing countries being imported, this leaves them prey to unscrupulous market influences and puts patients’ lives at risk. Governments need to put in place policies that will address all elements related to medical devices, ranging from access to high quality, affordable products, through to their safe and appropriate use and disposal. 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.

Surprisingly, regulatory controls for medical devices are scarce in the developing world, even though implementation of national medical device regulations will often address the very issues raised in countries as major concerns for patient safety. Examples of these issues include the illegal re-processing and re-packaging of used syringes for re-sale; the availability on the market of equipment that fails minimum quality and safety standards; or simply no trace of what devices are being sold in the country, nor by whom. Such a listing is essential to enable governments to issue alerts or recalls for unsafe or ineffective items.

The purpose of this publication is to provide guidance to countries wishing to create or modify their own regulatory systems for medical devices. It is recognized that there is no single template that will respond to the needs of every country. Some countries may have production facilities that will require good manufacturing practice and complex quality controls; others may depend principally on the donation of equipment from external sources and need different policies to protect their population against unsafe and inappropriate technology. Resources, both human and financial, remain a significant factor in the progressive development of national regulatory authorities. Nevertheless, there are many ways that governments can benefit from the wealth of experience of others, and start to build efficient medical device regulatory systems. This publication highlights the most important of these.In essence, governments are encouraged to follow the growing movement towards harmonized regulatory systems because a proliferation of different national regulations increases costs, hinders access to health care technologies, and can even unwittingly jeopardize the safety of the patient. Secondly, countries can adopt where appropriate the device approvals of the advanced regulatory systems, since this process represents a vast, and often unnecessary drain on scarce resources.

This will allow countries with weak regulatory systems to place emphasis and initial resources on areas such as vendor and device registration, training, and surveillance and information exchange systems on the assessment of medical devices in use. This guide will provide a useful framework within which countries can assess and address their needs to protect their populations from the risks of unsafe technology.

Medical Device Regulations – Global Overview and Guiding Principles



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