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FACT SHEET International Trade of Medical Devices Technological advances in pharmaceuticals and medical devices have significantly improved global health by increasing life expectancies, relieving disease symptoms, reducing infectious disease prevalence, and treating chronic diseases.1, 2 Achieving improvements in health with new technology depends on proper research, manufacturing, sale and use of these products. While pharmaceuticals provide a biological and chemical component to healing ailments or alleviating pain, medical devices provide the means of delivering care. According to the Global Harmonization Task Force (GHTF) a medical device is, “an instrument, apparatus, machine, implant, software, or appliance, 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 intended functions by such means.â€?3 The current pertinent issues facing international medical devices are: • A global harmonization of device manufacturing, sale, and use standards; • The restriction and monitoring of the sale and distribution of used and/or refurbished medical devices in the international marketplace; • The development of low-tech medical devices that can be used in resource poor and underdeveloped areas of the least developed countries (LDCs).

Global Harmonization Task Force In 1992 the Global Harmonization Task Force (GHTF) was established to create greater uniformity of medical devices across international boundaries. The organization is comprised of medical device manufacturers from around the world, as well as device regulatory agencies, including the United States Food and Drug Administration. The governing body of GHTF is made up of representatives from the United States, Japan, Canada, the European Union and Australia, but in recent years has served as a forum for other nations to participate in talks and learn from established medical device regulatory regimes.3 A retrospective assessment of the accomplishments of the GHTF was undertaken in 2008 through an exhaustive analysis of its policies and a survey given to the participating nations. The following results suggest the degree to which GHTF has achieved certain goals:4 To what degree has GHTF encouraged technical innovation?

To what degree has GHTF promoted the safety, performance, effectiveness and quality of medical devices?

To what degree has GHTF fostered international trade?








Used and Refurbished Medical Devices Medical devices are often expensive and produced in small quantities. As a result, there is a demand for used and refurbished devices in the international marketplace, specifically in developing countries. In general, remanufactured medical devices put on the market are of high quality and have undergone extensive testing before resale. Even so, a survey of 104 World Trade Organization (WTO) member states identified seventeen nations that restrict the importation of refurbished medical devices, while five others completely prohibited it.5 The reasons for prohibiting refurbished devices are largely to ensure safety and effectiveness; in addition, there are some devicespecific issues raised by some countries. A number of countries have stressed the importance of reducing or eliminating non-tariff barriers that limit or restrict the importation of refurbished medical devices in the Doha Round of the WTO talks. Eliminating these barriers can offer many benefits to developing countries, including reduced prices and greater opportunity for investment (i.e., development of a domestic remanufacturing industry).6

Access to Medical Devices for Low Income Countries While the remanufacture of used medical devices would be beneficial to developing countries, it should be noted that many countries do not have the infrastructure set up to utilize the devices created by industrialized nations. The WHO estimates that 50 percent of the medical equipment in developing countries is not functioning or is improperly used or maintained.7 Some of the major barriers to medical device use in developing countries includes, but are not limited to: •

A lack of spare parts to repair broken or worn devices;

• • •

Poor infrastructure, such as lack of functional electricity and water systems; A lack of consumables, such as liquids, electrodes, or test strips, needed to use the device; Inadequately trained staff.

In response to these technological shortcomings, many doctors and medical technology experts agree that new low-tech solutions must be developed specifically for low-income countries. Certain organizations (e.g., Program for Appropriate Technology in Health (PATH)) and universities (e.g., The Duke-EWH Competition for Underserved, Resource-poor Economies (CUREs)) have begun programs to train engineers to design specifically for underserved, resource-poor economies.8

Further Reading Global Harmonization Task Force: FDA Medical Device Unit: Advamed: References 1. 2. 3. 4.

APRIL 2010

5. 6. 7. 8.

GHTF Study Group 1. Information Document Concerning the Definition of the Term “Medical Device.” Global Harmonization Task Force. SG1-N29R16:2005. WHO. Medical Device Regulations: Global Overview and Guiding Principles. World Health Organization. 2003. GHTF Study Group 1. GHTF Overview and Mission. Global Harmonization Task Force. GHTF Steering Committee. GHTF Retrospective Assessment of Key Findings and Recommendations. Global Harmonization Task Force. Jan 11. 2008. Harper, Steven. Global Import Regulations for Pre-owned (used and refurbished) Medical Devices. U.S. Department of Commerce. September 2003. WTO. Market Access for Non Agricultural Products: Negotiating NTBs related to Remanufacturing and refurbishing. World Trade Organization. TN/MA/W/18/Add.11. December 5, 2005. WHO. Management, Maintenance and Use of Medical Devices. World Health Organization. 2010. Malkin, Robert. Barriers for Medical Devices for the Developing World. Expert Review of Medical Devices. 4(6),759-763 (2007).

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International Trade of Medical Devices