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New Comparative Law Report — Approval of Medical Devices

November 14, 2014 Comments off

Approval of Medical Devices (PDF)
Source: Law Library of Congress

This report describes the approval process for medical devices in the European Union and fifteen countries, and also indicates whether or not an expedited approval procedure is available. Many of the countries reference EU law, including France, Germany, the Netherlands, and Switzerland. Israel more readily approves devices with a CE mark (indicating approval in the EU) or an indication that they are approved by the US Food and Drug Administration (FDA). In many nations, particularly those influenced by the EU, part of the review process is conducted not by the government but by private, independent organizations called “notified bodies.” These organizations are designated by EU Member States.

In most of the countries in the survey, medical devices are categorized based on the risks associated with their use, and the approval process varies by category. For example, in the United Kingdom, manufacturers of low-risk devices may register with the government agency and simply declare that the devices meet the requirements to be approved. Devices classed as higher risk must undergo more detailed review, by a notified body.

On the question of an expedited approval process, Australia, Canada, China, Japan, Spain, and Switzerland permit some sort of rapid review in particular cases, often when a device is required for an individual patient and no substitute is available. Mexico has provided for more rapid approval of devices if they have already been approved in either Canada or the United States. No such procedure exists at present in Brazil, France, Israel, the Russian Federation, or the United Kingdom. The Russian Federation did have a rapid approval system in place prior to August 2014. Germany provides for temporary approval of devices in limited circumstances. South Africa is now considering draft legislation that would include expedited procedures in specified situations.

AU — Defence: a quick guide to key internet links

November 13, 2014 Comments off

Defence: a quick guide to key internet links
Source: Parliamentary Library of Australia
Categories include:

  • Australian Parliament
  • Australian Government
  • Military history
  • Strategic studies
  • Australian think tanks and non-government organisations
  • International think tanks and organisations
  • Foreign defence

Meat and Poultry Inspection 2.0: How the United States can learn from the practices and innovations in other countries

November 13, 2014 Comments off

Meat and Poultry Inspection 2.0: How the United States can learn from the practices and innovations in other countries
Source: Pew Charitable Trusts/Center for Science in the Public Interest

This food safety report, written by Pew and the Center for Science in the Public Interest (CSPI), highlights the need to modernize the meat and poultry inspection system in the United States to better protect consumers from the health risks posed by contaminated food.

Salmonella, E. coli, and other foodborne bacteria and viruses are nearly impossible to detect with the naked eye. Yet U.S. inspections still rely on methods developed a century ago, primarily visual examination of animals and carcasses.

Meat and Poultry Inspection 2.0 looks at the practices used by five countries and the European Union to better address the microscopic hazards that pose the greatest risks to public health. Pew and CSPI recommend that the United States find opportunities for improving meat and poultry inspection by commissioning comprehensive scientific assessments of its current approach and increasing the collection and analysis of data on food animals and production facilities.

The Modern Outback: Nature, people and the future of remote Australia

October 23, 2014 Comments off

The Modern Outback: Nature, people and the future of remote Australia
Source: Pew Charitable Trusts

The Outback is the vast heartland of Australia. It includes places of exquisite beauty and wildness. It is an area of extremes, alternately lush and bountiful, harsh and inhospitable. The people and land of the Outback embody much that is most distinctive and characteristic of Australia. Yet while the Outback is quintessentially Australian, it is also a place of international consequence.

The Outback has deeply interconnected threads of people and landscapes. Its natural environments support people, jobs, and economies, as well as some of the world’s most diverse and unusual plants and animals. The Outback’s environmental values merit the attention and concern of the nation and the world. However, some of these values are being lost, diminished, or degraded because of particular threats. Managing these risks more effectively, or removing them entirely, would allow for significant progress in ongoing efforts to maintain the environmental, natural and cultural values of the Australian continent as a whole.

What Would Happen If Health Care in the U.S. Improved?

October 23, 2014 Comments off

What Would Happen If Health Care in the U.S. Improved?
Source: Commonwealth Fund

The United States health care system is the most expensive in the world, but the Commonwealth Fund report Mirror, Mirror on the Wall, 2014 Update: How the U.S. Health Care System Compares Internationally shows the U.S. underperforms relative to 11 other industrialized countries on most dimensions of performance. Use this interactive to see what would happen if the U.S. were to raise its health system performance to the levels achieved elsewhere in the world.

Witness Protection Programs in Selected Countries

October 17, 2014 Comments off

Witness Protection Programs in Selected Countries (PDF)
Source: Public Safety Canada

Effective witness protection is a cornerstone of the criminal justice system in the fight against organized crime. Traditional witness protection focuses on the safety of the witness. Experience shows, however, that individuals are not willing unless they have confidence that the State will protect their rights and safety as well as those of their immediate family.

Witness protection programs serve many purposes. They provide opportunities for victims and witnesses to participate in a criminal process with the expectation that they and their families will not be put in danger. They offer the hope of accountability and give threatened witnesses a way to seek shelter from the scene of victimization. Witness protection provides a space in which individual traumas may be treated and enables a victim/witness to regain more control over their life. It can also lead to a serious disruption of the lifestyle of the witness and any persons accompanying them into the program. It may even have implications for third parties. For these reasons, witness protection programs must have a good foundation in legislation or policy.

This paper reviews the practices and outcomes of witness protection programs using open source literature on the legislation and practices followed in Australia, the United Kingdom (UK) and the United States (US) and compares them with both federal and provincial programs in Canada.

Australian crime: Facts & figures: 2013

September 24, 2014 Comments off

Australian crime: Facts & figures: 2013
Source: Australian Institute of Criminology

Australian Crime: Facts & Figures uses information compiled from a broad range of sources to create an accurate and holistic picture of crime and criminal justice issues in Australia. Within this volume are the patterns and trends relating to specific crimes, victims, offenders, the location of criminal acts and the operation and cost of the criminal justice system (including the police, courts and prisons).

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