Health products policy and standards

For specific questions on dossier preparation, data requirements and templates for ITNs, please refer to WHO guideline for cuntspin prequalification 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.

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 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.
• 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 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.