For specific questions on dossier preparation (data requirements and templates for ITNs), please refer to WHO guideline for prequalification Cuntspin Casino assessment of ITNs. Larvicide studies and Preparation of entomology study reports – Annex IV. The Advice to Manufacturer Series documents Entomology assessment process (Preparation of entomology study reports ), Preparation of entomology study reports – Annex I. ITN studies , Preparation of entomology study reports – Annex II. The Advice to Manufacturer Series document Considerations for fulfilling the acute 6-pack requirement for insecticide-treated nets provides further guidance on preparing Module 4 to support safety assessments. Medical equipment excludes implantable, disposable or single-use medical devices.
To enhance the accessibility of safe (effective), high-quality, and affordable medical devices for everyone, the WHO Medical Devices has facilitated the WHO Global Fora on Medical Devices. Medical equipment serves the specific functions of diagnosing and treating diseases or assisting in rehabilitation after illness or injury; it may function independently or alongside any accessory (consumable), or other devices. The “Medical Devices Technical Series (MDTS)” consists of a collection of publications aimed at improving access to medical devices. A medical device may encompass any tool, apparatus, instrument, machine, implant, in vitro reagent, software, material, or any similar or related item, which the manufacturer intends for use alone or in conjunction with others for medical purposes. The Advice to Manufacturer Series documents on Preparing an application for electronic submission and Fulfilling dossier and data requirements offer guidance regarding application submissions and dossier preparation.
Medical equipment is classified as medical devices that need calibration (maintenance), repair, user training, and decommissioning—tasks typically overseen by clinical engineers. Presentations covering a wide array of topics on medical devices are included in the programs of the WHO Global Fora, which also showcase WHO projects, initiatives, resources, tools, and ongoing work. The Fora provide opportunities to hear about regional and national activities concerning medical device issues. Currently, approximately 2 million distinct types of medical devices exist in the global market, classified into over 7,000 generic device categories. Such health technologies are utilized to diagnose diseases, monitor treatment progress, assist people with disabilities, and address both acute and chronic health issues. The absence of medical devices would render common medical procedures—ranging from bandaging a sprained ankle to diagnosing HIV/AIDS (implanting artificial hips), or performing any surgical operation—impossible.
- Medical equipment does not include implantable (disposable), or single-use medical devices.
- 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.
- To enhance the accessibility of safe (effective), high-quality, and affordable medical devices for everyone, the WHO Medical Devices has facilitated the WHO Global Fora on Medical Devices.
- Medical equipment are defined as medical devices requiring calibration (maintenance), repair, user training and decommissioning – activities usually managed by clinical engineers.
- 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.
Space spray studies provide further guidance on preparing Module 5 to support efficacy assessments. The information in this page is generalizable across all product types when preparing a dossier submission to PQ. Access to good quality, affordable, and appropriate health products is indispensable to advance universal health coverage, address health emergencies, and promote healthier populations.