The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
Here is practical advice for anyone who wants to build their business by selling overseas. The International Trade Administration covers key topics such as marketing, legal issues, customs, and more. With real-life examples and a full index, A Basic Guide to Exporting provides expert advice and practical solutions to meet all of your exporting needs.
This book presents theories and case studies for corporations in developed nations, including Japan, for designing strategies to maximize opportunities and minimize threats in business expansion into developing nations. The case studies featured here focus on Asia, including China and India, and use examples of Japanese manufacturers. Five case studies are provided, including Hitachi Construction Machinery and Shiseido in China and Maruti Suzuki in India. These cases facilitate the reader’s understanding of the business environments in emerging economies. This volume is especially recommended for business people responsible for international business development, particularly in China and India. In addition, the book serves as a useful resource for students in graduate-level courses in international management.
This updated and revised edition outlines strategies and models for how to use technology and knowledge to improve performance, create jobs and increase income. It shows what skills will be required to produce, sell and manage performance over time, and how manual jobs can contribute to reduce the consumption of non-renewable resources.
This compilation of 22 firm-specific case studies is an important contribution to the discussion of 'servicification' trends in manufacturing. 'Services have increased in importance and value in many manufacturing value chains, making companies that produce physical products look more like service enterprises. What services do global value chains use in their operations, how important are they and how do economic policies shape firms' configurations, operations, and location of global value chains? This book addresses these questions and more.The interviewed firms, based in 12 APEC economies, come from different sectors ranging from multinational automotive, construction equipment, and electrical appliance manufacturers to small and medium manufacturers of watches or chemical for water treatment. The book analyses what specific services are important in different stages of the value chain, and whether they are typically provided in-house or outsourced.
