Regulations for medical devices in EU Member countries are governed by European Medicine Evaluation Authority, popularly known as EMEA. As per EMEA's guideline each member country has to strictly follow the common guidelines with exception to rules and regulation that are modified by state authorities but must be in conformity with EMEA Guideline. Regulations posed in here are further divided in implantable and active implantable medical devices thereafter where manufacturing, testing and distribution can only be done once it is CE marked. In case of non CE marked devices i.e. non-EU member manufacturer, market authorisation process shall be completed prior to approval and separately. For brazil market that is governed by ANVISA, medical devices are classified into four different classes. There is no independent discrimination made for Active implantable medical devices but most non invasive devices are covered in Class I. While those which are to be connected with blood storage and other devices are classified into class II. Class III devices are those which are connected or included with wounds or healthy tissues.
This thesis analyses the regulation of medical devices in the United States of America and in the European Union. It covers the principles of health economics and fundamental aspects of the regulation of medical devices in both trade regions. It will focus on the legal framework and the different approaches used to secure patient health and safety. The role of EU Member States and the European Commission as competent authorities in the EU and the FDA as a governmental body in the US is explained. Case studies from both regimes will demonstrate failures and changes for the regulation of medical devices are proposed at the end of the thesis.
Computer System Validation is a mandatory requirement as per various regulatory authorities. Major ones are USFDA, EMEA, Swissmedic and Health canada. This book is based on generally recognized software validation principles and, therefore, can be applied to any software. This guidance applies to any software related to a regulated medical device, It does not specifically identify which software is or is not regulated.
This report was commissioned by the English Department of Health to inform the process of regulatory reform. It addresses two key questions related to assuring the quality of medical practice in a comparative context: how doctors' continuing competence is assessed and how poor medical practice is detected and what action is then taken. The research method was to select seven countries with advanced health care systems but different forms of funding. Using existing literature, web-based data and personal contacts, country/state profiles were developed to address the key questions in each country. A cross-country analysis identified a trend towards assessing competence on a regular basis with an emphasis either on continuing education or on regular performance assessment for revalidation, using different techniques. Three different models for identifying and acting on poor performance were identified. In conclusion, the report identified good practice and the choices open to policy makers in the context of the regulatory system in England.
Metal ion release from metallic materials, e.g. metallic alloys and pure metals, implanted into the human body in dental and orthopedic surgery are becoming a major cause for concern. This book briefly provides an overview of both metallic alloys and pure metals used in implant materials in dental and orthopedic surgery. Additionally, a short section is dedicated to important biomaterials and their corrosive behavior in both real solutions and various types of media that model human biological fluids and tissues. The present book gives an overview of analytical methods, techniques and different approaches applied to measurement of in vivo trace metals released into body fluids and tissues from patients carrying metal-on-metal prosthesis and metal dental implants. Reference levels of ion concentrations in body fluids and tissues that have been determined by a host of studies are compiled, reviewed and presented in this paper. Finally, a collection of published clinical data on in vivo released trace metals from metallic medical implants is included.
Trading Up – Consumer & Environmental Regulation in a Global Economy (Paper)
The book examines the causes, course, and repercussions of the 2008 global financial crisis. Chapter one examines the root causes of the 2008-2009 global financial crisis, course it has taken, in the US and the Global economy. Chapter two examines the impact of the US financial crisis, which culminated into a fully fledged financial crisis and is in part to blame for the ongoing European debt and economic crisis, on US socioeconomic and politics. Chapter three presents an in-depth look at securitization, highlighting how a mix of financial liberalization amid lax financial supervision and regulation, contributed much to aggravating the impact of the 2008-2009 financial crisis. Chapter four looks at the reverberations of the global financial crisis on the global economic and political order, reflected in the emerging global economic and political order and international relations, with special emphasis on Opportunities and Challenges in Revitalizing Asia-Africa Cooperation. Chapter five takes a closer look at the opportunities and challenges for cooperation and collaboration between ASIA and African Nations within an emerging global economic and political order.
This paper explores the regulation of the financial sector, with particular emphasis on the banking industry. It tries to evaluate existing regulation policies, their effect on economic activity and their effectiveness in keeping the sanctity of the financial sector. It gives an overview of its basis and changes through time and some of its inherent problems. It also looked through previous works, at the effectiveness of regulation on financial stability. The Canadian Financial sector was used as a case study following its apparent resilience to the 2007/08 financial crisis that rocked the world. Being an industrialized country and a member of the G10, this has caused a lot of interest in the regulatory structure and practice of the country with a view to testing its adaptability to different countries. It then concludes on whether regulation really did play a pivotal role in the resilience or it was based on other conditions and circumstances.