{"id":225051,"date":"2026-02-19T15:10:02","date_gmt":"2026-02-19T12:10:02","guid":{"rendered":"https:\/\/new-inbit.dev-praxis.gr\/?post_type=hta_library&p=225051"},"modified":"2026-02-19T15:10:02","modified_gmt":"2026-02-19T12:10:02","slug":"medical-device-regulations-global-overview-and-guiding-principles","status":"publish","type":"hta_library","link":"https:\/\/www.inbit.gr\/el\/hta_library\/medical-device-regulations-global-overview-and-guiding-principles\/","title":{"rendered":"Medical device regulations: global overview and guiding principles"},"content":{"rendered":"\n

Summary of contents<\/strong><\/p>\n\n\n\n

Chapter 2 describes the nature of medical device safety as a risk management process that must encompass the life span of medical devices from their conception to disposal. A Life Span Diagram facilitates understanding and serves as a memory anchor. Optimum safety and performance require cooperation among all those involved in the life span of a medical device: the manufacturer, importer\/vendor, government, user and public \u2013 each has a specific role to play in risk management.<\/p>\n\n\n\n

Chapter 3 considers the role of the government. The critical elements of the life span of medical devices that require regulatory attention are highlighted. A common regulatory framework is proposed integrating the five regulatory systems with the most advanced medical device regulations, along with the applicable regulatory tools.<\/p>\n\n\n\n

Chapter 4 introduces the work of the Global Harmonization Task Force (GHTF), whose mission is to harmonize the implementation of medical device regulations across the globe. The objectives of its four Study Groups as they relate to the Medical Device Life Span Diagram are described. In order to facilitate ease of reference for countries wishing to adopt them, Annex 2 provides a summary of all final GHTF documents as they relate to the common regulatory framework.<\/p>\n\n\n\n

Chapter 5 provides an introduction to standards. It describes the use of voluntary standards and their increasing prominence in medical device regulation. Countries are urged to establish national standards management systems and, where possible, to adopt international standards and to participate in their development and amendment.<\/p>\n\n\n\n

Chapter 6 suggests various steps for governments seeking to establish an affordable regulatory programme from the ground up for ensuring the safety and performance of medical devices. The need for knowledge, policies, legislation and enforcement of medical device safety is discussed. Governments are encouraged to avoid setting up resource demanding \u201cpre-market\u201d regulations, but rather to take advantage of existing approval systems and international standards. An explanation of the meaning of different medical device \u201cexport certificates\u201d is offered. Cooperation from all stakeholders is encouraged to increase programme effectiveness while reducing regulatory costs.<\/p>\n\n\n\n

Chapter 7 proposes two actions that could be undertaken at the international level to address priority needs for product control and their safe and effective use:<\/p>\n\n\n\n

i) The establishment of a uniform certification format that will be used globally so that different countries can certify that medical devices being exported comply with their domestic regulatory requirements. This certification will help the importing countries to regulate medical devices.<\/p>\n\n\n\n

ii) Support for a centre to coordinate and relay medical device problems, recalls, and alerts to the global community. This will enhance the safety and performance of medical devices in use around the world.<\/p>\n","protected":false},"featured_media":0,"template":"","categories":[18],"tags":[],"class_list":["post-225051","hta_library","type-hta_library","status-publish","hentry","category-guidelines"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/hta_library\/225051","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/hta_library"}],"about":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/types\/hta_library"}],"wp:attachment":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/media?parent=225051"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/categories?post=225051"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/tags?post=225051"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}