Health products policy and standards
Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.

Product Policies, Access and Manufacturing Support Unit

Unit Head Office

Technical Teams

Dr Jicui Dong - Unit Head

Essential Medicines and Substances Access and Use

Medical Devices and Assistive Technology

Product Development and Manufacturing Support

Assistive technology publications

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Assistive technology progress assessment questionnaire: tracking progress on access to assistive technology

In May 2018, the World Health Assembly (WHA) adopted resolution WHA71.8 on improving access to assistive technology. The resolution urges Member States...

Improving access to assistive technology in United Republic of Tanzania (2022-2023): project report

The report summarizes a collaboration between the Ministry of Health of the United Republic of Tanzania, HelpAge Tanzania and the World Health Organization...

Enabling rapid access to essential assistive technology in Ukraine (2022-2023): project report

This report summarizes a collaboration between the Ministry of Health of Ukraine and the World Health Organization (WHO) in 2022 and 2023. The goal was...

Accelerating access to assistive technology: Eastern Mediterranean Regional workshop report, Cairo, Egypt, 3-5 December 2024

From 3 to 5 December 2024, the World Health Organization (WHO), in collaboration with the United Nations Children’s Fund (UNICEF), convened a regional...

Essential medicines publications

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The selection and use of essential medicines, 2025: WHO AWaRe (Access, Watch, Reserve) classification of antibiotics for evaluation and monitoring of use

The AWaRe classification is intended as a tool for monitoring antibiotic use, defining targets and monitoring the impact of stewardship policies and interventions...

The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines for Children, 10th list

Essential medicines are those that satisfy the priority health care needs of a population. They are selected with due regard to disease prevalence and...

The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list

Essential medicines are those that satisfy the priority health care needs of a population. They are selected with due regard to disease prevalence and...

The selection and use of essential medicines, 2025: report of the 25th WHO Expert Committee on Selection and Use of Essential Medicines, executive summary

This executive summary reports the recommendations made by the Expert Committee on Selection and Use of Essential Medicines for the 2025 update of the...

In vitro diagnostics publications

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The selection and use of essential in vitro diagnostics: report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (‎including the fourth WHO model list of essential in vitro diagnostics)‎

The Technical report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model...

Target product profile for readers of rapid diagnostic tests

Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including...

Selection of essential in vitro diagnostics at country level: using the WHO Model List of Essential In Vitro Diagnostics to develop and update a national list of essential in vitro diagnostics

This document intends to provide guidance to countries on methods for developing and updating national lists of essential in vitro diagnostics (NEDL)....

Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics

Post-market surveillance is a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have...

Medical devices publications

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Development of medical device policies, 2nd ed.

A first edition of the Development of Medical Devices Policies was published in 2011. This second edition was prepared to reflect the transition from the...

Availability, price and affordability of health technologies for the management of diabetes

The WHO list of priority medical devices for management of cardiovascular diseases and diabetes, https://iris.who.int/handle/10665/341967, describes those...

Inventory and maintenance management information system for medical devices

Health-care technology has played a fundamental role in medicine for centuries, evolving with scientific advances to improve patient diagnosis, treatment...

Health technology assessment of medical devices, 2nd ed

HTA is a multidisciplinary process used to evaluate the clinical, economic, ethical implications and social impact of new health technologies. This...

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