Guide to Distributors of Medical Equipment and Supplies Worldwide [March 2011] PDF Download

Author: Espicom Business Intelligence
Publisher:
ISBN: 9781858224169
Category : Medical instruments and apparatus industry
Languages : en
Pages :

View

Book Description

Author:
Publisher:
ISBN: 9781858223230
Category : Medical instruments and apparatus industry
Languages : en
Pages :

View

Book Description

Author: World Health Organization
Publisher:
ISBN: 9789241512350
Category : Law
Languages : en
Pages : 72

View

Book Description
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.

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241564040
Category : Medical
Languages : en
Pages : 147

View

Book Description
Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Author: Orlando Lopez
Publisher: Taylor & Francis
ISBN: 1351704346
Category : Business & Economics
Languages : en
Pages : 232

View

Book Description
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.

Author: Jack W. Plunkett
Publisher: Plunkett Research, Ltd.
ISBN: 1593921322
Category : Medical care
Languages : en
Pages : 734

View

Book Description
This acclaimed and popular text is the only complete market research guide to the American health care industry--a tool for strategic planning, competitive intelligence, employment searches or financial research. Covers national health expenditures, technologies, patient populations, research, Medicare, Medicaid, managed care. Contains trends, statistical tables and an in-depth glossary. Features in-depth profiles of the 500 major firms in all health industry sectors.

Author: Orlando Lopez
Publisher: CRC Press
ISBN: 1040083706
Category : Business & Economics
Languages : en
Pages : 262

View

Book Description
Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is

Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32

View

Book Description

Author: World Health Organization
Publisher:
ISBN: 9789241565462
Category : Medical instruments and apparatus
Languages : en
Pages : 246

View

Book Description
This is the model list and clearing house of appropriate, basic, and priority medical devices based on the list of clinical interventions selected from clinical guidelines on prevention, screening, diagnosis, treatment, palliative care, monitoring, and end of life care. This publication addresses medical devices that can be used for the management of cancer and specifically describes medical devices for six types of cancer: breast, cervical, colorectal, leukemia, lung, and prostate. This book is intended for ministries of health, public health planners, health technology managers, disease management, researchers, policy makers, funding, and procurement agencies and support and advocacy groups for cancer patients.

Author: Health and Human Services Supply Service Center (U.S.)
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 506

View

Book Description