Jun 16, 2024 · Member States recognized in World Health Assembly (WHA) resolutions WHA60.29 (2007) and WHA 67.20 (2014) that medical devices are indispensable for health-care delivery but that their selection, regulation and use present enormous challenges, especially for low- and middle-income countries (LMIC).

Apr 6, 2011 · Medical equipment is used for the specific purposes of diagnosis and treatment of disease or rehabilitation following disease or injury; it can be used either alone or in combination with any accessory, consumable or other piece of medical equipment. Medical equipment excludes implantable, disposable or single-use medical devices.

Jul 8, 2024 · MeDevIS references two international naming systems for medical devices - the European Medical Device Nomenclature , mostly used in European countries for registration in the European database, and the Global Medical Device Nomenclature used in regulatory agencies in Australia, Canada, the United Kingdom and the USA and other Member States. The ...

Oct 9, 2024 · The FDA last updated the database on Aug. 7, 2024. The FDA compiled the list using product codes and device summaries. The list is not exhaustive, but it is intended to be representative of devices that incorporate AI/ML across medical disciplines, the agency said. The definition of a device includes hardware and software features.

Mar 1, 2025 · One device is a modification of a system to treat mitral valve regurgitation that works by bringing the valve leaflets together at the areas of most severe leakage. The other device delivers a new valve made of cow heart tissue, which …

Feb 12, 2025 · Medical device companies rely on overseas sourcing, and they may be producing devices in the U.S. but sourcing raw materials and assemblies from other countries. “We live in an interdependent world, and if we want to break those interdependencies, it is not going to happen overnight,” said Willy Shih, a professor at the Harvard Business School.

Jul 30, 2021 · Medical devices include from a syringe, catheters and surgical mask, to complex devices like pacemakers and prothesis to magnetic resonance. WHO global lists of priority medical devices help improve access to suitable medical devices, increase safety, support quality of care and strengthen health care systems.

Nov 25, 2022 · national lists of priority medical devices; high cost medical equipment. The GAMD also identifies that Member States designate a focal point for health technologies and medical devices. Each Member State designates a focal point in the ministry of health with the survey responses. WHO Baseline Country Survey on Medical Devices was developed in ...

Feb 17, 2017 · WHO Medical device technical series. This project was developed by the World Health Organization (WHO) in response to the need for a model reference list of basic and priority medical devices required for cancer management, with the goal of increasing access to these medical devices especially in low- and middle-income countries .

Medical devices should be safe, of good quality and appropriate to the settings in where they are used. Recognizing this important role of health technologies towards universal health coverage, the World Health Assembly adopted resolution WHA60.29 in M