The country profiles incorporate facts indicating the national status of medical devices in areas such as: medical device policies, regulations, incorporation, lists, inventories, nomenclature, health technology assessment, management, and biomedical engineering resources. This publication is int...ended for use as a reference by decision-makers in Ministries of Health, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional, or global levels.
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Global Atlas of medical devices 5 August 2017
WHO medical devices technical series
The occurrence of a high percentage of couterfeit medicines on the global medicines market is often attributed to a lack of effective regulation and a weak enforcement capacity. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information... on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world.
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MINISTERIAL ORDER Nº 002/17/10/TC OF 27/10/2017 DETERMINING THE FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES | Official Gazette nº 46 of 13/11/2017
This document is updated.
Please check the document:Priority medical devices list for the COVID-19 response and associated technical specifications
The decontamination of instruments and medical devices plays a very important role in the prevention of health care-associated infections (HAIs). Indeed, improper decontamination of surgical instruments, endoscopic devices, respiratory care devices and reusable haemodialysis devices still occurs in ...many settings, leading to HAIs. This course is based on the WHO manual on decontamination and reprocessing of medical devices for health care facilities, as well as in collaboration with the US CDC.
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23 February 2021
This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the latest available evidence and interim guidelines. This includes: oxygen therapy, pulse oximeters, patient monitors, thermometers, infusion and suc...tion pumps, X-ray, ultrasound and CT scanners as well as personal protective equipment. In order to facilitate access to quality assured priority medical devices, the document also includes technical and performance characteristics, related standards, accessories and consumables. It is intended for policy-makers and planning officers in Ministries of Health, procurement and regulatory agencies, intergovernmental and international agencies as well as the medical device industry.
This document is an update to the List of priority medical devices for COVID-19 case management and Technical specifications for invasive and non-invasive ventilators for COVID-19.
This document complements the Technical specifications of personal protective equipment for COVID-19.
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23 February 2021
This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the latest available evidence and interim guidelines. This includes: oxygen therapy, pulse oximeters, patient monitors, thermometers, infusion and suc...tion pumps, X-ray, ultrasound and CT scanners as well as personal protective equipment. In order to facilitate access to quality assured priority medical devices, the document also includes technical and performance characteristics, related standards, accessories and consumables. It is intended for policy-makers and planning officers in Ministries of Health, procurement and regulatory agencies, intergovernmental and international agencies as well as the medical device industry.
This document is an update to the List of priority medical devices for COVID-19 case management and Technical specifications for invasive and non-invasive ventilators for COVID-19.
This document complements the Technical specifications of personal protective equipment for COVID-19.
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This publication was developed in response to the need for a reference list of priority medical devices required for management of noncommunicable diseases (NCDs), focusing on cardiovascular diseases and diabetes, especially for low- and middle-income countries to support universal health coverage a...ctions.
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This publication is 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 for six types of cancer: breast, cervical, colorectal, leukem...ia, lung and prostate. The first section defines the global increase in cancer cases, the global goals to manage NCDs and the WHO activities related to these goals. The second section presents the methodology used for the selection of medical devices that support clinical interventions required to screen, diagnose, treat and monitor cancer stages, as well as the provision of palliative care, based on evidence-based information. The third section lists the priority medical devices required to manage cancer in seven different units of health care services: 1. Vaccination, clinical assessment and endoscopy, 2. Medical imaging and nuclear medicine, 3. Surgery, 4. Laboratory and pathology, 5. Radiotherapy, 6. Systemic therapy and 7. Palliative and end of life care
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The objective of this project was to list the medical devices required to provide the essential reproductive, maternal, newborn and child health interventions defined by existing WHO guidelines and publications, in order to improve access to these devices in low- and middle-income countries, support... quality of care, and strengthen health-care system. The medical devices are allocated across the reproductive, maternal, newborn and child health continuum of care according to the level of health-care delivery.
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This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medicines, medical devices and IVDs.
Over the last three or four decades, there has been an enorm...ous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
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n the countries of the Region of the Americas, there are different forms of organization of health services at the first level of care. Some countries include certain laboratory, dental and diagnostic imaging practices in the first level of care, while other countries centralize these practices in t...he second and third levels of care. Consequently, so that the List of Priority Medical Devices (LPMD) could be adapted to these different forms of organization of health systems in the region of the Americas, modular lists were developed that complement the main list. In this way, to use the LPMD, only those modules that are planned to be offered in a first-level care center are selected, and it is those lists that are analyzed.
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Resource platform.
The Global Atlas of medical devices (GAMD) provides global, regional and country data on availability of:
national policy on health technology
regulation of medical devices
health technology assessment national unit
health technology management
use of med...ical devices nomenclature system
national lists of priority medical devices
high cost medical equipment.
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Fact Sheet Global Atlas of medical devices
GDF is the largest global provider of quality-assured tuberculosis (TB)
medicines, diagnostics, and laboratory supplies to the public sector.
Since 2001, GDF has facilitated access to high-quality TB care in over 130
countries, providing treatments to over 30 million people with TB and procuring
...
and delivering more than $200 million worth of diagnostic equipment
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Decontamination of medical devices plays an important role in the prevention of health care-associated infections. It includes cleaning, disinfection and/or sterilization. The processes involved in decontamination are complex, require specific infrastructure and equipment, and involve several sequen...tial steps that need to be performed correctly – from device collection and receipt by the decontamination unit to processing, storage and distribution throughout the facility. Quality control procedures (such as validation) at each step of the decontamination process are of the utmost importance to ensure the correct functioning of the equipment and processes. This aide-memoire presents a concise overview of important advice and key elements at a glance.
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