Regulation of medical devices outside the European Union

Abstract

The regulation of medical devices across the world is very varied, ranging from comprehensive to none. Over the past two decades, the number, range, and complexity of medical devices has increased. Regulation of these devices has also evolved due to an increasing awareness of the need for a more consistent approach to regulatory documentation. This will aid both manufacturers selling a product in more than one country, and the countries introducing regulation. Current initiatives are working towards manufacturers being able to produce a single set of documents that will fulfil the requirements of all regulatory authorities. In 2001 the World Health Organization (WHO) published ‘A model regulatory programme for medical devices: An international guide’1 which provided a framework to assist member states in establishing regulatory programmes for medical devices. The guide was based on experiences from areas that had already established comprehensive regulatory programmes. The aim was to provide information to nations without medical device regulatory systems that would enable the production of internationally compatible regulations. In 2003 the WHO published ‘Medical device regulations. Global overview and guiding principles’,2 in which it highlighted the complexity of the medical device industry and identified issues related to regulation. This document provided guidance to member states wishing to create or modify their regulatory systems for medical devices. The WHO is continually prompting harmonized medical device regulation through a range of initiatives, the most recent being the First Global Forum on Medical Devices held in Bangkok during September 2010. At the Bangkok meeting it was reported that: approximately 30% of countries have a developed framework for regulation of medical devices; approximately 30% of countries only have partial regulation of medical devices; remaining countries are either developing a framework or do not yet have any regulation.3 The Global Harmonization Task Force (GHTF) was founded in 1992 in response to a growing need for international harmonization of medical device regulation. This is a voluntary group comprised originally of representatives from the medical device regulatory authorities of the five founding members USA, European Union (EU), Japan, Australia and Canada. In 2006, membership was expanded to include the AHWP, International Organization for standardization (ISO), and the International Electrotechnical Commission (IEC). The International Organization for Standardization (ISO) was set-up in 1946 to facilitate the international coordination and unification of industrial standards. ISO is a network of national standards institutes in 163 countries, and is now the world's largest developer and publisher of voluntary international standards. ISO standards are widely adopted at regional and national level, and underpin the procedures and practices of medical device development, manufacture, quality control and conformity assessment requirements. In the global market these standards provide governments with a technical base for health, safety and environmental requirements, and aid the transfer of good practice and knowledge to developing countries. Standards can be obtained from the ISO website (http://www.iso.org/iso/home.html). There are a large number of standards that relate to medical devices and some of the most important include: ISO 13485 Medical devices – Quality management systems – Requirements for regulatory processes (this is a specific medical device standard based on ISO 9001); ISO 10993 Biological evaluation of medical devices; ISO 14155 Clinical investigation of medical devices for human subjects; ISO 14971 Medical devices – Application of risk management to medical devices.