INSTITUTION PROFILE / BIOSENSORS
World Health Organization (WHO)
An international body that runs prequalification of in vitro diagnostics and publishes an essential diagnostics list, with no legal regulatory power over any country
WHO is the United Nations' specialised agency for health and has 194 Member States. Its main work touching biosensors falls in three areas: prequalification of in vitro diagnostics, the Essential Diagnostics List (EDL), and guidance that supports the building of medical device regulation. WHO's prequalification, however, is a quality check for procurement by United Nations agencies and others; it is not a national approval. WHO itself states that inclusion in its list does not imply approval, which is solely the prerogative of national authorities. This profile looks at one question only: how much influence WHO has over biosensors. It contains no advice on how to use any product or on any reader's personal health.
What this article covers
- WHO in 30 seconds
- What kind of body it is: the four types of influence
- What it does for biosensors
- How far its influence reaches (powers and geography)
- Companies and organisations involved
- Outlook
- Glossary, references and claim-to-source audit
1. WHO in 30 seconds
FULL NAMEWorld Health Organization (WHO)The United Nations specialised agency for health
REGIONInternational (headquarters in Geneva)Six regional offices and more than 150 locations (WHO's description)
TYPE OF BODYUN specialised agency194 Member States. The highest decision-making forum is the World Health Assembly
ESTABLISHEDConstitution in force 7 April 1948The Constitution was adopted on 22 July 1946
STAFFMore than 8,000Professionals, as stated on WHO's website
BUDGETUS$6.83 billion (2024-25)The approved programme budget for the biennium. We did not confirm the 2026-27 figure. Assessed contributions are under a quarter of financing
ROLE IN BIOSENSORSPrequalification, the EDL, regulatory guidancePoint-of-care blood glucose and HbA1c systems are within the scope of prequalification
REACHInternational, with no legal regulatory powerReferred to by UN procurement and by national list-making
The one thing to grasp first
"Prequalified by WHO" is not the same as national approval. The note on WHO's prequalified list states that inclusion does not imply WHO approval (which is the sole prerogative of national authorities) and that the listed products have not necessarily obtained regulatory approval in any country Sourced. Prequalification helps United Nations agencies and others choose quality-assured diagnostics when they buy. Do not confuse it with authorities such as the FDA or Japan's Ministry of Health, Labour and Welfare, which decide what may be sold in their own countries.
2. What kind of body it is: the four types of influence
The "institutions" that appear in articles on biosensors (medical devices and in vitro diagnostics) do not make products the way companies do. They can be sorted into four types by the route through which they influence the industry. WHO is a "convening" body, one that issues guidance and recommendations.
3. What it does for biosensors
| Activity | What the primary sources say | Link to biosensors |
|---|---|---|
| Prequalification of in vitro diagnostics | Launched in 2010. The main activities are assessment of product dossiers, labelling review and inspection of manufacturing sites. A prequalified product is listed as acceptable, in principle, for procurement by UN agencies. Applying is voluntary and the list is not exhaustive | Point-of-care blood glucose systems and point-of-care HbA1c systems are within the scope of prequalification. But in the list we checked in October 2026 (125 products), no product appeared under "Glucose meters and test strips" |
| Essential Diagnostics List (EDL) | A model list that serves as a reference when countries draw up their own lists (now in its fifth edition). It shows which tests should be available at each level of care. The expert group SAGE IVD reviews applications and makes recommendations | Six tests are listed under diabetes mellitus, including blood glucose (glucose meter, test strips and associated calibrators and controls, in point-of-care and self-testing formats) and glycated haemoglobin (point-of-care and laboratory) |
| Support for medical device regulation | Under World Health Assembly resolution WHA60.29 it helps Member States put regulation and surveillance in place. It published the WHO Global Model Regulatory Framework for medical devices including in vitro diagnostic medical devices (2017) and a step-by-step guide. WHO is an official observer on the management committee of the International Medical Device Regulators Forum (IMDRF) | A reference for countries building their own rules. The content of regulation is decided by each country |
| Emergency Use Listing (EUL) | A procedure for infectious-disease emergencies, with pages for COVID-19, mpox and Ebola among others | Not directly relevant to glucose sensors (this profile does not cover it in detail) |
| General policy on diagnostics | WHO treats diagnostics as essential to care at every level and supports Member States' mechanisms for assessing, selecting and using them | These are policy documents; they do not decide whether an individual product may be used |
Note: the list of IVDs eligible for prequalification was last updated on 27 September 2026, and we checked the list of prequalified products on 4 October 2026. WHO says that from 2026 performance evaluation becomes a procedure separate from the prequalification assessment.
What WHO's documents do not do
The note on the prequalified list says that inclusion is not an endorsement of any product, and not a warranty of fitness for a purpose, and does not mean the product has regulatory approval in any country Sourced. It also says that a product's absence from the list does not mean it would fail the standards. This profile does not rank or judge any particular glucose meter or CGM, and it contains no medical advice for any reader.
A materials engineer's view: WHO documents show the intended setting
WHO's documents separate tests by assay format that reflects where they are used: no laboratory, self-testing, point-of-care, laboratory. In the EDL, for example, "glucose" appears as point-of-care, self-testing, laboratory optical methods on analysers, and dipstick formats Sourced. For a supplier of materials or components, this is less a source of regulatory thresholds than a clue to the setting a device is assumed to be used in. Specific performance thresholds are set elsewhere, in United Nations procurement documents and national regulators' documents, which this profile does not cover.
4. How far its influence reaches (powers and geography)
| Aspect | What WHO has | What it does not have |
|---|---|---|
| Powers | Assessing IVDs for prequalification and maintaining the list (for procurement by UN agencies and others). Producing the Essential Diagnostics List. Publishing a model regulatory framework and guides for medical devices. Supporting Member States under World Health Assembly resolutions | Legal regulatory power over any country. Approving a product for sale. Making its documents legally binding |
| Geography | Addressed to 194 Member States. The main users are UN agencies and bodies that take part in their procurement; countries use the documents as references for their own lists and rules | Whether a product may be sold in a given country. The decisions of national regulators (the FDA, the Ministry of Health, Labour and Welfare and PMDA, the European Commission and others) |
| International frameworks | Official observer on the IMDRF management committee. It also recognises regional bodies such as the Asian Harmonization Working Party (AHWP) | A decision-making role in the IMDRF (it is an observer) |
| Scale | More than 8,000 staff, 194 Member States and six regional offices. The 2024-25 programme budget was US$6.83 billion; assessed contributions are under a quarter of financing and the rest comes from voluntary contributions | We could not confirm a budget or headcount for diagnostics prequalification alone |
| Reach of regulation | A desk survey in 2015-2016 found that 58% of Member States had some regulation for medical devices, however limited | Enforcement in countries without regulation |
5. Companies and organisations involved
The figure below shows what WHO's two mechanisms (prequalification and the EDL) produce, and for whom. National approvals sit outside WHO's mechanisms.
| Organisation | Relationship with WHO (what primary sources confirm) | Category |
|---|---|---|
| UN agencies and other procurers | They use the prequalified list when selecting products to buy. Organisations using the list are told to check other aspects separately, such as the supplier's finances and supply capacity and the registration status of the products in the country concerned | Sourced |
| National regulators (the FDA, MHLW and PMDA, the European Commission and others) | They hold the power of approval. WHO states that the list does not substitute for national approval. WHO also has a procedure that uses its prequalification assessments to speed registration in countries (the Collaborative Procedure for Accelerated Registration); this profile does not cover it in detail | Sourced |
| IMDRF | WHO is an official observer on its management committee | Sourced |
| Companies | Manufacturers' names appear in the prequalified list, but in October 2026 no product was listed under "Glucose meters and test strips". This profile does not rank individual companies | Sourced |
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| From 2026, in WHO's IVD prequalification, performance evaluation is separated from the assessment and becomes its own procedure | The notice on WHO's prequalification page. The procedure itself is set out in the overview document, version 10 (1 January 2026) | Sourced |
| Point-of-care blood glucose and HbA1c systems are within the scope of prequalification, in the group for which performance evaluation is not currently required | Table 2 of WHO's list of IVDs eligible for prequalification (updated 27 September 2026). WHO says the tables are updated regularly | Sourced |
| We could not confirm whether any product will be prequalified under "Glucose meters and test strips" | As of 4 October 2026 the category held no product. Whether applications exist is on a separate page ("IVDs under assessment"), which we did not check | Not yet confirmed |
| The EDL is revised periodically, and diabetes-related tests may be updated at a revision | The EDL About page: the list is updated through periodic calls for applications and review. We could not confirm the timing of the next revision | Not yet confirmed |
| WHO looks set to continue supporting national list-making and regulatory strengthening in diagnostics | WHO's diagnostics page (support for national lists) and medical device regulation page (capacity building). It has no legal power | Inference |
7. Glossary
- Prequalification
- WHO's assessment of a product's dossier, labelling and manufacturing sites to confirm quality for procurement by UN agencies and others. It is not a national approval.
- Essential Diagnostics List (EDL)
- WHO's model list of essential in vitro diagnostics, a reference for countries' own lists.
- SAGE IVD
- WHO's Strategic Advisory Group of Experts on IVDs. It reviews applications to the EDL and makes recommendations.
- Emergency Use Listing (EUL)
- A WHO procedure for infectious-disease emergencies.
- World Health Assembly
- WHO's highest decision-making forum, which brings together delegates of all Member States every year.
- IMDRF
- The International Medical Device Regulators Forum. WHO is an official observer on its management committee.
- Point-of-care (POC)
- Testing done near the patient rather than in a laboratory.
8. References
- WHO Who we are: 194 Member States, six regional offices, more than 150 locations and more than 8,000 professionals. https://www.who.int/about/who-we-are
- WHO The WHO Constitution: adopted on 22 July 1946, in force since 7 April 1948; the UN specialised agency for health. https://www.who.int/about/governance/constitution
- WHO Programme budget: the 2024-25 programme budget of US$6.83 billion and its structure. https://www.who.int/about/accountability/budget
- WHO Funding: assessed contributions account for under a quarter of financing; the rest is voluntary. https://www.who.int/about/funding
- WHO (Prequalification) In Vitro Diagnostics: overview of IVD prequalification (launched 2010, main activities, the change of procedure from 2026). https://extranet.who.int/prequal/vitro-diagnostics
- WHO (Prequalification) IVDs Eligible for WHO Prequalification: the tables of eligible IVDs, including point-of-care blood glucose and HbA1c systems (updated 27 September 2026). https://extranet.who.int/prequal/vitro-diagnostics/vitro-diagnostics-eligible-who-prequalification
- WHO (Prequalification) Prequalified In Vitro Diagnostics: the note on the list (no WHO approval; approval is for national authorities; how to use the list in procurement; disclaimers). https://extranet.who.int/prequal/vitro-diagnostics/prequalified-vitro-diagnostics
- WHO (Prequalification) WHO list of Prequalified In Vitro Diagnostic Products: 125 products; no product in the category Glucose meters and Test Strips (checked on 4 October 2026). https://extranet.who.int/prequal/vitro-diagnostics/prequalified/in-vitro-diagnostics
- WHO Electronic WHO Model list of essential in vitro diagnostics: fifth edition; diabetes tests, glucose meter, test strips and associated calibrators and controls, and glycated haemoglobin. https://edl.who-healthtechnologies.org/
- WHO About the EDL: purpose, use as a reference for national lists, and review by SAGE IVD. https://edl.who-healthtechnologies.org/about
- WHO Diagnostics: WHO's role (promoting the EDL, supporting Member States, strengthening regulatory capacity). https://www.who.int/health-topics/diagnostics
- WHO Medical devices, quality and safety regulations: resolutions WHA60.29 and WHA67.20, the Global Model Regulatory Framework, IMDRF observer status and the 58% figure. https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/regulations
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| WHO's structure: 194 Member States, six regional offices, more than 150 locations and more than 8,000 professionals | Sourced | Reference 1 https://www.who.int/about/who-we-are |
| The Constitution's adoption (22 July 1946) and entry into force (7 April 1948); a UN specialised agency | Sourced | Reference 2 https://www.who.int/about/governance/constitution |
| The 2024-25 programme budget of US$6.83 billion; assessed contributions under a quarter of financing | Sourced | Reference 3 https://www.who.int/about/accountability/budget Reference 4 https://www.who.int/about/funding |
| The start of prequalification (2010), its main activities (dossier assessment, labelling review, site inspection) and the change of procedure from 2026 | Sourced | Reference 5 https://extranet.who.int/prequal/vitro-diagnostics |
| Point-of-care blood glucose and HbA1c systems being within the scope of prequalification, with performance evaluation not currently required | Sourced | Reference 6 https://extranet.who.int/prequal/vitro-diagnostics/vitro-diagnostics-eligible-who-prequalification |
| The note on the prequalified list (no approval implied, approval is for national authorities, listed products not necessarily approved anywhere, use in procurement) | Sourced | Reference 7 https://extranet.who.int/prequal/vitro-diagnostics/prequalified-vitro-diagnostics |
| 125 prequalified products and no product under Glucose meters and Test Strips (checked on 4 October 2026) | Sourced | Reference 8 https://extranet.who.int/prequal/vitro-diagnostics/prequalified/in-vitro-diagnostics |
| The fifth-edition EDL's diabetes tests (glucose meter, test strips and calibrators and controls; glycated haemoglobin) | Sourced | Reference 9 https://edl.who-healthtechnologies.org/ |
| The EDL's purpose, use as a reference for national lists, and review by SAGE IVD | Sourced | Reference 10 https://edl.who-healthtechnologies.org/about |
| WHO's role on diagnostics (EDL, support for Member States, regulatory capacity) | Sourced | Reference 11 https://www.who.int/health-topics/diagnostics |
| Support for device regulation (WHA60.29, the 2017 Global Model Regulatory Framework, IMDRF observer, 58% of Member States) | Sourced | Reference 12 https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/regulations |
| The four types of institution, and the layout of Fig. 2 | Our calculation | Our own classification |
| Whether any product will be prequalified under Glucose meters and Test Strips, and the timing of the next EDL revision | Not yet confirmed | Not stated in the references; this article does not estimate it |
| A budget or headcount for diagnostics prequalification alone | Not yet confirmed | Not stated in the references; this article does not estimate it |
| The inference in section 6 | Inference | This article's reading of references 5, 11 and 12 |
Last updated 4 October 2026 / Troy Technical
All figures come from WHO's official website. Items marked "Inference" are this article's reading of the primary information. Nothing here is advice on how to use any product or on any reader's personal health.