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Policy and standards for health products.

  • September 23, 2026

Please consult the WHO guideline on prequalification cuntspin casino online assessment of ITNs for specific inquiries regarding data requirements (templates), and dossier preparation. Annex IV covers both larvicide studies and the preparation of entomology study reports. The documents in the Advice to Manufacturer Series outline the entomology assessment process (as well as the preparation of entomology study reports found in Annexes I and II), including ITN studies. Further guidance on preparing Module 4 to assist safety assessments is offered in the Advice to Manufacturer Series document addressing the acute 6-pack requirement for insecticide-treated nets. Disposable (single-use), and implantable medical devices are not considered medical equipment.

In order to increase access to appropriate, safe, affordable, effective medical devices of quality for all; the WHO Medical Devices has enable the WHO Global Fora on Medical Devices. 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. The “Medical Devices Technical Series (MDTS)” is a series of publications intended to increase access to medical devices. A medical device can be any instrument (apparatus), implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose. The Advice to Manufacturer Series documents Preparing an application for electronic submission and Fulfilling dossier and data requirements provide guidance on dossier preparation and submission of applications.

Medical equipment are defined as medical devices requiring calibration, maintenance, repair, user training and decommissioning – activities usually managed by clinical engineers. The programmes of the WHO Global Fora have include presentations on the a huge range of topics on medical devices and also help present WHO projects, initiatives, tools, resources and work in progress. The Fora also serve as occasions to listen to regional and country activities on medical devices issues. Today, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups. Such health technologies are used to diagnose illness (to monitor treatments), to assist disabled people and to intervene and treat illnesses, both acute and chronic. Without medical devices (common medical procedures – from bandaging a sprained ankle), to diagnosing HIV/AIDS, implanting an artificial hip or any surgical intervention – would not be possible.

  • Medical equipment excludes implantable, disposable or single-use medical devices.
  • The WHO Global Fora programs feature a wide array of presentations regarding medical devices and showcase WHO projects — tools, initiatives, resources, and ongoing work.
  • To enable the WHO Global Fora on Medical Devices — the WHO Medical Devices initiative aims to improve access to quality, safe, affordable, and effective medical devices for all.
  • Medical equipment are defined as medical devices requiring calibration, maintenance, repair, user training and decommissioning – activities usually managed by clinical engineers.
  • Medical equipment serves the specific functions of diagnosing and treating diseases or rehabilitating individuals after illness or injury; it may be utilized independently or alongside any accessories, consumables, or other medical devices.

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Additional guidance for preparing Module 5 to support efficacy assessments is provided through space spray studies. The information presented on this page can be applied universally across all product types when submitting a dossier to PQ. Facilitating access to quality (affordable), and suitable health products is crucial for advancing universal health coverage, tackling health emergencies, and fostering healthier populations.

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