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Prequalified Medical Devices

Prequalified Medical Devices

Prequalified Medical Devices

The List of WHO-prequalified medical devices have been assessed by WHO and found to be acceptable, in principle, for procurement by UN agencies. 

The WHO List of Prequalified Medical Devices is updated regularly, generally with the inclusion of newly prequalified products.   

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In addition to the list of prequalified medical devices, WHO Prequalification Public Reports for prequalified medical devices are posted on website. 

Medical Devices Delisted from the WHO Prequalification List

No delisted products 

NOTE: WHO reserves the right to suspend or delist (as determined by WHO) a prequalified product from WHO's list of prequalified medical devices, in the following cases:

  1. WHO may delist or suspend the product in the case of failure or delay by the manufacturer to comply with any post-qualification obligations and requirements as described in the document “WHO’s prequalification procedure for medical devices” in Section 11. The foregoing includes, but is not limited to, the failure or delay by the manufacturer to participate in or to allow WHO to conduct any routine or non-routine inspections.
  2. WHO may delist or suspend the product if serious or critical non-conformities or concerns (including with respect to quality, safety and/or performance of the prequalified product or any of its manufacturing sites) are identified as described in Section 8.4 of the document “WHO’s prequalification procedure for medical devices”; and/or
  3. WHO may delist or suspend the product if WHO determines (including based on the outcomes/results of any routine or non-routine manufacturing site(s) inspection) that the prequalified product or any of its manufacturing sites no longer meet(s) WHO’s applicable requirements.

In addition, at any time or stage, the manufacturer may: (1) withdraw its application for WHO’s prequalification assessment, or (2) withdraw a product or manufacturing site from WHO’s prequalification listing; provided, however, that the manufacturer must provide WHO with prior written notice specifying the product(s)/manufacturing site(s) to be withdrawn.

General information – WHO List of Prequalified Medical Devices

The WHO List of Prequalified Medical Devices is updated regularly, generally with the inclusion of newly prequalified products.

Medical devices are added to the list (following the voluntary participation of relevant applicants) as and when the data on such products has been considered to meet WHO prequalification requirements, as described. WHO may suspend or remove products from the list based on information that may subsequently become available to it.

Please note that:

  • The list is not an exhaustive list of medical devices available for use.
  • The fact that certain products and suppliers are not included in the list does not mean that if assessed, evaluated and tested, they would not be found to comply with the above-mentioned standards.
  • Inclusion in the list does not imply any approval by WHO of the products and manufacturing sites in question (which is the sole prerogative of national authorities).
  • This list may not be used by manufacturers and suppliers for commercial or promotional purposes.

Suggestions relating to procurement

  • Any UN organization intending to use the list of prequalified products for procurement should ensure that only products from the manufacturing sites mentioned in this list are supplied to it.
  • Procurement organizations using this list for procurement should perform other aspects of qualification prior to purchasing, such as ensuring financial stability and standing of the supplier, ability to supply the required quantities and other related aspects, including the registration status of the products they wish to procure.
  • This list does not constitute any guarantee for the procurement of the products from the suppliers mentioned.

Disclaimer to the WHO List of Prequalified Medical Devices

1)  Inclusion in this list does not constitute an endorsement, or warranty of the fitness, by WHO of any product for a particular purpose, including in regard to its safety and/or efficacy.

2)  WHO does not furthermore warrant or represent that:
•    the list is complete or error free; and/or that;
•    the products and manufacturing sites which have been found to meet the standards recommended by WHO, will continue to do so; and/or that;
•    the products listed have obtained regulatory approval for their specified use or any other use in any country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including but not limited to patent laws.

3)  In addition, WHO wishes to alert procuring agencies that the improper storage, handling and transportation of medical products may affect their quality, efficacy and safety.

4)  WHO disclaims any and all liability and responsibility for any injury, death, loss, damage or other prejudice of any kind whatsoever that may arise as a result.