Medical device vigilance systems: India, US, UK, and Australia
نویسندگان
چکیده
The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF) was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. In the Indian regulatory system, medical devices are still considered as drugs. In 2006, the Medical Device Regulation Bill was recommended to consolidate laws for medical devices and to establish the Medical Device Regulatory Authority of India. In addition, medical devices are not classified by any Indian regulatory authority. Although India has moved towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify whether India should have a vigilance system in harmony with those of GHTF or develop its own system for medical devices.
منابع مشابه
The Knowledge Translation Complexity Network (KTCN) Model: The Whole Is Greater Than the Sum of the Parts - A Response to Recent Commentaries
متن کامل
A glance at the move from complementary alternative medicine (CAM) to integrative medicine in the United Kingdom (UK), United States (US), and World Health Organization (WHO)'s health care systems
Today's medical world has gained a growing appeal towards CAM/TM which can be seen in the strategies of US in the form of establishing National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH) and White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) at the White House, the annual increase of integration of CAM clas...
متن کاملUsing Complexity and Network Concepts to Inform Healthcare Knowledge Translation
Many representations of the movement of healthcare knowledge through society exist, and multiple models for the translation of evidence into policy and practice have been articulated. Most are linear or cyclical and very few come close to reflecting the dense and intricate relationships, systems and politics of organizations and the processes required to enact sustainable improvements. We illus...
متن کاملComparing the Active Centers in the Area of Ethics in Science and Technology in the US, UK, China and India
Background: Nowadays, life increasingly relies on inclusive scientific and technological infrastructures. Today, the use of technology has been manifested in all aspects of people's lives, so that decision-making processes in all aspects are based on the indicators of science and technology. Science has even come up with issues such as ethics and tradition, so traditional issues of ethics in th...
متن کاملA glance at the move from complementary alternative medicine (CAM) to integrative medicine in the United Kingdom (UK), United States (US), and World Health Organization (WHO)'s health care systems
Today's medical world has gained a growing appeal towards CAM/TM which can be seen in the strategies of US in the form of establishing National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH) and White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) at the White House, the annual increase of integration of CAM clas...
متن کامل