scholarly journals To Recognize the Use of International Standards for Making Harmonized Regulation of Medical Devices in Asia-Pacific

2010 ◽  
Vol 2 (3) ◽  
pp. 321-325
Author(s):  
K. Anand ◽  
K.S. Saini ◽  
Y. Chopra ◽  
S.K. Binod
Keyword(s):  
Medical Devices ◽  
International Standards ◽  
Asia Pacific

Antimicrobial Resistance Control Strategies: A Coordinated Research Initiative Experience in the Asia Pacific Region

2017 ◽  
Vol 29 (4) ◽  
pp. 250-258
Author(s):  
Lisette Lapierre ◽  
Gabriela Asenjo ◽  
Constanza Vergara ◽  
Javiera Cornejo
Keyword(s):  
Antimicrobial Resistance ◽  
Control Strategies ◽  
International Standards ◽  
Asia Pacific ◽  
Pacific Region ◽  
Asia Pacific Region ◽  
Antimicrobial Surveillance ◽  
Research Initiative ◽  
The Status ◽  
Survey Results

The objective was to gather information on the status of antimicrobial surveillance in the Asia Pacific region and suggest control strategies. Twenty-one economies of the Asia Pacific region participated in this initiative. A survey was conducted on antimicrobial use and surveillance throughout the region. A workshop was carried out to create awareness about the issue and discuss the implementation of control strategies. Based on the survey results and workshop conclusions, it can be established that there is better understanding of the implications of antimicrobial resistance in the human medicine area. Only few economies take actions to control antimicrobial resistance on a veterinary/agricultural level. To confront antimicrobial resistance, it is critical to raise awareness; cooperation between all countries is needed to apply international standards, to be able to have harmonized public policies. Countries must align and improve their systems for surveillance and monitoring of antimicrobial resistance in human, animals, and the environment.

Neurosurgical materials and devices

1976 ◽  
Vol 45 (3) ◽  
pp. 251-258 ◽  
Author(s):  
Charles V. Burton ◽  
Joseph T. McFadden
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
International Standards ◽  
Current Status ◽  
Reference Source ◽  
Legal Authority ◽  
Content Type ◽  
Fine Print

✓ The current status of voluntary consensus standards writing procedures in neurosurgery and the current progress of government efforts to regulate materials and devices are described. A survey of the national and international standards writing bodies is presented, along with an introduction to related organizations and agencies and nomenclature. The intent of this review is to provide the neurosurgeon with a reference source regarding past and present neurosurgical activities in the materials and devices field. When President Ford signed the 1976 Medical Device Amendments on May 28, 1976, the Food and Drug Administration assumed direct legal authority to control medical devices and potentially assumed the power to regulate those professionals using them.

Clinical Trial of a Novel Starch-Based Adhesive Bandages for Medical Dressing

2020 ◽  
Vol 990 ◽  
pp. 96-100
Author(s):  
Sittiporn Punyanitya ◽  
Banyong Khantawa ◽  
Sakdiphon Thiansem ◽  
Rungsarit Koonawoot ◽  
Phanlob Chankachang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Medical Devices ◽  
Raw Materials ◽  
Low Cost ◽  
International Standards ◽  
Preparation Methods ◽  
Safety And Efficacy ◽  
Plastic Components ◽  
Adhesive Bandage ◽  
Novel Starch

A typical adhesive bandage comprises of four main parts; the backing is often made of plastic; the adhesive sheet is usually plastic; the adhesive is commonly acrylate; the absorbent pad is often made of cotton. This adhesive bandages are made from starch based adhesive and natural paper, which have no plastic components. A starch-based adhesive bandages are tested on 100 volunteers and the result shows good performances with high confident of safety and efficacy. The raw materials and preparation methods are low cost, easily reproducible and eco-friendly, according to the international standards of medical devices regulation.

scholarly journals Comparison of Medical Device Regulations in India, Japan and South Korea

2021 ◽  
pp. 8-23
Author(s):  
Chandan B. V. ◽  
M. P. Venkatesh ◽  
Arjun M. ◽  
Pasupuleti Dheeraj Krishna ◽  
Indraprasad S.
Keyword(s):  
South Korea ◽  
Medical Device ◽  
Drug Administration ◽  
Drug Safety ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Asia Pacific ◽  
The South ◽  
South Korean ◽  
Medical Devices Act

Increased health awareness, a growing middle class, and government health efforts are projected to propel India's medical equipment market forward in the next years. With the publication of the Medical Device Rules in 2017, Indian authorities revised the medical device regulatory process. The devices included in the link are currently regulated medical devices and in vitro diagnostic devices, as well as their classifications. CLA (Central Licensing Authority) is in charge of all import device licencing, as well as manufacturing, loan, and wholesale licences for Class C and Class D medical devices. Because of its complicated registration process and linguistic obstacles, Japan is regarded one of the most difficult markets for overseas medical device producers. The Pharmaceutical and Medical Device Agency, which works in tandem with the MHLW (Ministry of Health and Labour Welfare), is in charge of reviewing drug and medical device applications in Japan. The Pharmaceuticals and Medical Devices Act is a federal law that regulates the sale of pharmaceuticals and medical devices. The Pharmaceuticals and Medical Devices Act, also known as the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics, lays out the current PMDA (Pharmaceuticals and Medical devices Agency) laws in Japan. South Korea is one of the largest health-care markets in the Asia-Pacific region. Medical Devices in South Korea are regulated by the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA). Medical Devices in South Korea are regulated by the Ministry of Food and Drug Safety, formerly known as the Korea Food and Drug Administration. The Medical Device Act of 2015 governs current medical device laws in Korea. To access the South Korean Medical-Device-Market, you must first obtain marketing approval from the local Medical Device Authority, the Medical Device Information & Technology Centre, which is part of the Ministry of Food and Drug Safety. With the MFDS notification No. 2020-29, the South Korean Ministry of Food and Drug Safety launched UDI (Unique Device Identification System) operations in 2018. Article 20 of the Medical Device Act and Article 54-2 of the Medical Device Act Enforcement Regulations make UDI compliance mandatory.

scholarly journals On the Way towards International Standards of Education

2021 ◽  
Author(s):  
Ю.А. Горячев ◽  
В.Ф. Захаров
Keyword(s):  
Higher Education ◽  
Bologna Process ◽  
International Standards ◽  
Asia Pacific ◽  
Turn Of The Millennium ◽  
State University ◽  
The Pacific ◽  
World Economic ◽  
Standard Classification ◽  
The Bologna Process

Представляем вниманию читателей заключительную часть статьи «На пути к международным стандартам образования», подготовленной специалистами факультета регионоведения и этнокультурного образования МПГУ. Установлен вклад в формирование глобального миропонимания идей великих русских ученых М.В. Ломоносова, В.И. Вернадского, К.Э. Циолковского и др. Отражен процесс становления общего образовательного пространства и международной стандартной классификации образования. Говоря о современной глобализации рубежа тысячелетий, авторы отмечают нарастающую взаимозависимость мира — экономическую, социально-культурную и политическую. Особое внимание обращено на ее роль в развитии интеграционных процессов образования, в том числе формирование Российской Федерацией совместно с другими участниками СНГ, ЕАЭС, АТР, ШОС общего евразийского образовательного пространства; закрепление в рамках Болонского процесса договоренностей об общеевропейском образовательном пространстве; принятие при содействии ЮНЕСКО региональных конвенций стран Африки, Азиатско-Тихоокеанского региона, Арабского Востока, Средиземноморья и Латинской Америки о признании квалификаций в области высшего образования. И, наконец, принятие первого в системе ООН международно-правового документа в области образования с глобальным охватом — Глобальной конвенции о признании квалификаций, относящихся к высшему образованию. Статью дополняет приложение с перечнем основных международно-правовых актов в области образования. In this edition of the almanac «Ethnodialogy» the third, and final, part of the article «Towards international standards of education: from pedagogy of early thinkers to modern approaches» is published. The article is prepared by the specialists of the Faculty of regional studies and ethnocultural education of the Moscow Pedagogical State University. It tells us about the contribution of the ideas of the great Russian scientists M.V. Lomonosov, V.I. Vernadsky, K.E. Tsiolkovsky, and others to the formation of the Global worldview. Both the process of development of the Common educational environment and the International standard classification of education are presented in the article. Speaking about the modern globalization at the turn of the millennium, the authors note the growing interdependence of the world — economic, sociocultural, and political. Special attention is paid to its role in the development of integration processes in education, including the formation of a common Eurasian educational space by the Russian Federation together with other members of the CIS, the EAEU, the Asia-Pacific region, and the SCO; the consolidation of agreements on a pan-European educational space within the framework of the Bologna Process; the adoption, with the assistance of UNESCO, of the regional conventions for the recognition of qualifications in higher education in Africa, Asia and the Pacific, the Arab East, the Mediterranean and Latin America. And, finally, the adoption of the first international legal instrument in the UN system in the field of education with a global scope — the Global Convention on the Recognition of Qualifications concerning Higher Education. The article is followed by the Supplement «The main international legalacts in the field of education».

scholarly journals THE ROLE OF THE UNITED NATIONS ECONOMIC AND SOCIAL COMMISSION FOR ASIA AND THE PACIFIC IN PROMOTING REGIONAL COOPERATION IN PROTECTING THE RIGHTS OF PERSONS WITH DISABILITIES

2020 ◽  
Vol 35 (3) ◽  
pp. 71-77
Author(s):  
E.N. Yakovleva ◽  
Keyword(s):  
Significant Contribution ◽  
Social Issues ◽  
Regional Cooperation ◽  
International Standards ◽  
Asia Pacific ◽  
Persons With Disabilities ◽  
The Pacific ◽  
Unique Experience ◽  
Basic Content

The article is devoted to the activities of the UN ESCAP in terms of promoting the improvement of life of persons with disabilities in the Asia-Pacific region. In general, the problem of protecting and ensuring the rights of persons with disabilities is acutely on the agenda of most states of the world. But the urgency of this problem is not lost: people with disabilities face many violations of their rights in all spheres of society. The scientific novelty of this work is justified by the lack of research into the activities of the UN regional commissions in addressing pressing economic and social issues. Using comparative legal and formal legal methods, the work analyzes the unique experience of ESCAP in organizing three regional decades of disabled people; the main documents of the commission which provide carrying out of program actions are considered; the basic content of these documents is revealed; their features are allocated. The study concludes that ESCAP has made a significant contribution to promoting international standards on the rights of persons with disabilities in national policies of States in the region.

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