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.

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.

scholarly journals US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?

2012 ◽  
Vol 8 (1) ◽  
pp. 53-56 ◽  
Author(s):  
Jona A. Hattangadi ◽  
James T. O'Reilly ◽  
Abram Recht
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Radiation Oncology ◽  
Food And Drug Administration ◽  
Regulatory Framework ◽  
General Review ◽  
Medical Device Regulation

A review of the issues involved in medical device regulation in radiation oncology, including a general review of federal medical device regulation and explanations of the legal and regulatory framework.

The Ear, Nose, and Throat Devices Classification Panel of the Food and Drug Administration

1979 ◽  
Vol 87 (1) ◽  
pp. 27-31
Author(s):  
Ralph F. Naunton ◽  
Harry R. Sauberman
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Safety And Efficacy ◽  
Mode Of Entry ◽  
Nose And Throat

The passage into law in 1976 of the Medical Device Amendments authorized the FDA to regulate the safety and efficacy of medical devices. The effects of this regulation are contrasted with the mode of entry of medical devices onto the market prior to 1976. The structure and operation of Ear, Nose, and Throat Devices Classification Panel is described briefly. Continued input from otolaryngologists and allied professionals is encouraged.

Wyeth v. Levine: Challenging Implied Pre-emption for drugs

2009 ◽  
Vol 37 (3) ◽  
pp. 527-530
Author(s):  
Pooja Nair
Keyword(s):  
Supreme Court ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
State Law ◽  
Drug Labeling ◽  
The Supreme Court ◽  
Premarket Approval ◽  
Tort Claims

In March 2009, the Supreme Court held in Wyeth v. Levine that federal drug labeling laws do not pre-empt state tort claims against drug manufacturers. The decision surprised many Court watchers, coming on the heels of a 2008 decision, Riegel v. Medtronic, in which the Court found that the Food, Drug, and Cosmetic Act (FDCA) does pre-empt state-law claims for injuries caused by medical devices that received premarket approval from the Food and Drug Administration. Wyeth dealt an immediate and surprising blow to the pharmaceutical industry’s principal strategy for avoiding tort lawsuits, but failed to clarify the Court’s overall pre-emption jurisprudence.

scholarly journals Meat Demand in South Korea: An Application of the Restricted Source-Differentiated Almost Ideal Demand System Model

2007 ◽  
Vol 39 (1) ◽  
pp. 47-60 ◽  
Author(s):  
Shida Rastegari Henneberry ◽  
Seong-huyk Hwang
Keyword(s):  
United States ◽  
South Korea ◽  
The United States ◽  
System Model ◽  
Demand System ◽  
Almost Ideal Demand System ◽  
The South ◽  
Meat Demand ◽  
South Korean ◽  
Meat Market

The first difference version of the restricted source-differentiated almost ideal demand system is used to estimate South Korean meat demand. The results of this study indicate that the United States has the most to gain from an increase in the size of the South Korean imported meat market in terms of its beef exports, while South Korea has the most to gain from this expansion in the pork market. Moreover, the results indicate that the United States has a competitive advantage to Australia in the South Korean beef market. Results of this study have implications for U.S. meat exports in this ever-changing policy environment.

Changes in Twinning Rates in South Korea: 1981–2002

2005 ◽  
Vol 8 (1) ◽  
pp. 76-79 ◽  
Author(s):  
Yoon-Mi Hur ◽  
Jun Soo Kwon
Keyword(s):  
South Korea ◽  
Assisted Reproductive Technologies ◽  
Reproductive Technologies ◽  
Rapid Rise ◽  
The South ◽  
Older Mothers ◽  
South Korean ◽  
Record Data ◽  
Birth Data ◽  
National Statistical Office

AbstractThe present study investigates the twinning rate trends in South Korea for the years 1981 to 2002 utilizing the birth record data from the South Korea National Statistical Office. The twinning rates between 1981 and 1991 remained nearly constant and were slightly less than 10 twin individuals, that is, approximately five pairs per thousand births. Since the early 1990s, however, the twinning rate has increased sharply and reached 19.30 twin individuals, that is, around 10 pairs per thousand births in the year 2002. Application of the Weinberg method to birth data for the years 2000 to 2002 revealed that the dizygotic twin rate in South Korea increased almost threefold between 1981 to 1991 and 2002. In the 1980s the effect of maternal age on twinning rates appeared to be minimal. In the 1990s, however, increases in twinning rates occurred more markedly among older mothers than among younger mothers. We speculate that the rapid rise in twinning rates in South Korea in the 1990s is probably attributable to the spread of Assisted Reproductive Technologies among older mothers who seek treatments for infertility. The present study also examined whether residing in industrial areas is associated with multiple births in the South Korean population. The results did not support the recent finding of higher twinning incidence in industrialized regions.

SUIT CLAIMS RESEARCH-HOSPITAL DOCTORS SUBMITTED PHONY BILLS TO GET U.S. FUNDS

PEDIATRICS ◽  
1995 ◽  
Vol 96 (5) ◽  
pp. A41-A41
Author(s):  
J. F. L.
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Controversial Issue ◽  
Criminal Investigation ◽  
Research Hospital ◽  
Medical Centers ◽  
Cardiac Procedures ◽  
Hospital Doctors ◽  
The Government

Physicians at dozens of prominent research hospitals nationwide allegedly submitted phony bills and sometimes even falsified patients' records to obtain as much as $1 billion in federal payments for sophisticated, but still experimental, cardiac procedures, a newly unsealed whistleblower suit claims. The allegations of years of systematic fraud involving as many as 130 major medical centers nationwide, accusations that already have prompted a previously reported criminal investigation, are likely to shine a spotlight on the controversial issue of which cutting-edge devices and procedures currently are, or should be, eligible for Medicare or Medicaid claims. Existing regulations say that the government generally won't pay for treatment considered to be "experimental" or for the use of medical devices that haven't been formally approved by the Food and Drug Administration...

Sign in / Sign up

Export Citation Format

Share Document