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Global Harmonization Task Force
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry”GHTF General Information whose goal was the standardization of medical device regulation across the world. The representatives from its five founding members (the , the , , |
Medical Device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulatory
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in government, typically regulation (or its plural) refers to the delegated legislation which is adopted to enforce primary legislation; including land-use regulation * in economy: regulatory economics * in finance: financial regulation * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Forms Regulation in the social, politica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration (United States)
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers, cellular phones, and condoms. In addition, the FDA takes control of disea ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Industry (economics)
In microeconomics, an industry is a branch of an economy that Production (economics) , produces a closely related set of raw materials, Good (economics) , goods, or Service (economics) , services. For example, one might refer to the wood industry or to the insurance industry. When evaluating a single group or company, its dominant source of revenue is typically used by industry classifications to classify it within a specific industry. For example the International Standard Industrial Classification (ISIC) – used directly or through derived classifications for the official statistics of most countries worldwide – classifies "statistical units" by the "economic activity in which they mainly engage". Industry is then defined as "set of statistical units that are classified into the same ISIC category". However, a single business need not belong just to one industry, such as when a large business (often referred to as a conglomerate (company), conglomerate) Diversification (ma ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union
The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The union has a total area of and an estimated population of over 449million as of 2024. The EU is often described as a ''sui generis'' political entity combining characteristics of both a federation and a confederation. Containing 5.5% of the world population in 2023, EU member states generated a nominal gross domestic product (GDP) of around €17.935 trillion in 2024, accounting for approximately one sixth of global economic output. Its cornerstone, the European Union Customs Union, Customs Union, paved the way to establishing European Single Market, an internal single market based on standardised European Union law, legal framework and legislation that applies in all member states in those matters, and only those matters, where the states ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States
The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 contiguous states border Canada to the north and Mexico to the south, with the semi-exclave of Alaska in the northwest and the archipelago of Hawaii in the Pacific Ocean. The United States asserts sovereignty over five Territories of the United States, major island territories and United States Minor Outlying Islands, various uninhabited islands in Oceania and the Caribbean. It is a megadiverse country, with the world's List of countries and dependencies by area, third-largest land area and List of countries and dependencies by population, third-largest population, exceeding 340 million. Its three Metropolitan statistical areas by population, largest metropolitan areas are New York metropolitan area, New York, Greater Los Angeles, Los Angel ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Canada
Canada is a country in North America. Its Provinces and territories of Canada, ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, making it the world's List of countries and dependencies by area, second-largest country by total area, with the List of countries by length of coastline, world's longest coastline. Its Canada–United States border, border with the United States is the world's longest international land border. The country is characterized by a wide range of both Temperature in Canada, meteorologic and Geography of Canada, geological regions. With Population of Canada, a population of over 41million people, it has widely varying population densities, with the majority residing in List of the largest population centres in Canada, urban areas and large areas of the country being sparsely populated. Canada's capital is Ottawa and List of census metropolitan areas and agglomerations in Canada, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Japan
Japan is an island country in East Asia. Located in the Pacific Ocean off the northeast coast of the Asia, Asian mainland, it is bordered on the west by the Sea of Japan and extends from the Sea of Okhotsk in the north to the East China Sea in the south. The Japanese archipelago consists of four major islands—Hokkaido, Honshu, Shikoku, and Kyushu—and List of islands of Japan, thousands of smaller islands, covering . Japan has a population of over 123 million as of 2025, making it the List of countries and dependencies by population, eleventh-most populous country. The capital of Japan and List of cities in Japan, its largest city is Tokyo; the Greater Tokyo Area is the List of largest cities, largest metropolitan area in the world, with more than 37 million inhabitants as of 2024. Japan is divided into 47 Prefectures of Japan, administrative prefectures and List of regions of Japan, eight traditional regions. About three-quarters of Geography of Japan, the countr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Australia
Australia, officially the Commonwealth of Australia, is a country comprising mainland Australia, the mainland of the Australia (continent), Australian continent, the island of Tasmania and list of islands of Australia, numerous smaller islands. It has a total area of , making it the list of countries and dependencies by area, sixth-largest country in the world and the largest in Oceania. Australia is the world's flattest and driest inhabited continent. It is a megadiverse countries, megadiverse country, and its size gives it a wide variety of landscapes and Climate of Australia, climates including deserts of Australia, deserts in the Outback, interior and forests of Australia, tropical rainforests along the Eastern states of Australia, coast. The ancestors of Aboriginal Australians began arriving from south-east Asia 50,000 to 65,000 years ago, during the Last Glacial Period, last glacial period. By the time of British settlement, Aboriginal Australians spoke 250 distinct l ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Europe
Europe is a continent located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, the Mediterranean Sea to the south, and Asia to the east. Europe shares the landmass of Eurasia with Asia, and of Afro-Eurasia with both Africa and Asia. Europe is commonly considered to be Boundaries between the continents#Asia and Europe, separated from Asia by the Drainage divide, watershed of the Ural Mountains, the Ural (river), Ural River, the Caspian Sea, the Greater Caucasus, the Black Sea, and the waterway of the Bosporus, Bosporus Strait. "Europe" (pp. 68–69); "Asia" (pp. 90–91): "A commonly accepted division between Asia and Europe ... is formed by the Ural Mountains, Ural River, Caspian Sea, Caucasus Mountains, and the Black Sea with its outlets, the Bosporus and Dardanelles." Europe covers approx. , or 2% of Earth#Surface, Earth's surface (6.8% of Earth's land area), making it ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
North America
North America is a continent in the Northern Hemisphere, Northern and Western Hemisphere, Western hemispheres. North America is bordered to the north by the Arctic Ocean, to the east by the Atlantic Ocean, to the southeast by South America and the Caribbean Sea, and to the south and west by the Pacific Ocean. The region includes Middle America (Americas), Middle America (comprising the Caribbean, Central America, and Mexico) and Northern America. North America covers an area of about , representing approximately 16.5% of Earth's land area and 4.8% of its total surface area. It is the third-largest continent by size after Asia and Africa, and the list of continents and continental subregions by population, fourth-largest continent by population after Asia, Africa, and Europe. , North America's population was estimated as over 592 million people in list of sovereign states and dependent territories in North America, 23 independent states, or about 7.5% of the world's popula ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
