List of Contraceptive Devices Prequalified by UNFPA And Acknowledged* by WHO during a Transition Period

The United Nations Population Fund (UNFPA) no longer undertakes prequalification or post-qualification activities in respect of contraceptive devices.  Within the United Nations system, the prequalification and post-qualification assessment/activities concerning contraceptive devices is being transitioned to and will be carried out by the World Health Organization (WHO), pursuant to and in accordance with WHO’s new program and procedure for the prequalification of medical devices (including contraceptive devices). 

List to be added in Q4 2026

This List of Contraceptive Devices Prequalified by UNFPA and Acknowledged by WHO During a Transition Period (hereinafter, “this list”) sets forth the contraceptive devices that WHO understands/acknowledges have been assessed and prequalified by UNFPA as of the date of that list.   

*WHO’s acknowledgment in connection with this list is made subject to the following notes and disclaimers: 

1.  The purpose of this list is to acknowledge—during a transition period ending no later than 30 September 2030—those contraceptive devices that WHO understands have been assessed and prequalified by UNFPA as of the date of the list (such devices are hereinafter referred to as “Contraceptive Devices”).  

2.  While WHO understands/acknowledges that the Contraceptive Devices have previously been assessed and prequalified by UNFPA, WHO has not directly undertaken such activities.  Accordingly, neither this list nor anything contained in this list should be construed or interpreted to mean or imply that WHO: (a) has assessed or prequalified any Contraceptive Devices, or (b) has made any decision or finding regarding whether any Contraceptive Devices meet, in principle, WHO’s technical recommendations or standards.   

3.  WHO reserves the right to remove any Contraceptive Devices from this list including, but not limited to, in the following cases: 

a. If serious, major or critical non-conformities or concerns—including with respect to quality, safety and/or performance—in respect of a Contraceptive Device or any of its manufacturing site(s) are identified or otherwise come to the attention of WHO; 

b. In case of failure or delay by the manufacturer of a Contraceptive Device to comply with any applicable post-qualification obligations, including failure or delay to: 

i. Notify WHO in accordance with the instructions in the document “Reportable changes to WHO Prequalified and Emergency Use Listed IVD and non-IVD Medical Devices PQDx_121), of any reportable changes including:

  •    Any planned reportable changes to their Contraceptive Device; (which must be reviewed and approved by WHO prior to the implementation of such reportable change)  
•    Any reportable changes to their Contraceptive Device that have occurred since obtaining UNFPA prequalification listing, and which have not been previously assessed and approved under UNFPA’s change assessment procedure; and/or 

 ii.    Participate in or allow the conduct of any post-qualification routine or non-routine inspections of manufacturing site(s).  
c.    If by 30 September 2028, the manufacturer of the Contraceptive Device does not submit to WHO an application for WHO’s prequalification assessment of that Contraceptive Device under the terms of document PQDx 464 “WHO’s prequalification procedure for medical devices”  (hereinafter the “PQ Procedure”). 

4.  The fact that Contraceptive Devices and their manufacturers are included in this list does not mean that those products, manufacturers and/or their manufacturing sites: 
a. would—or would not—have been found by WHO to comply with the technical requirements/standards under the PQ Procedure, had they been assessed by WHO; or 
b. will—or will not—be found by WHO to comply with the technical requirements/standards under the PQ Procedure, should they be submitted to and assessed by WHO under that procedure.  

5.  The inclusion of any Contraceptive Devices in this list does not constitute or imply: (a) any endorsement, representation or warranty of any kind by WHO regarding the fitness of any Contraceptive Device for any particular purpose; and/or (b) any approval, authorization, license or registration by WHO of any products, their manufacturers and/or their manufacturing site(s).  It is the sole prerogative of national regulatory authorities to issue such approvals, authorizations, licenses and/or registrations.

6.  WHO makes no—and hereby disclaims any—representations and/or warranties of any kind with respect to this list or any Contraceptive Devices including, but not limited to, any representation or warranty that: (a) this list is accurate, complete or error-free; (b) the products, manufacturers and/or manufacturing sites included in this list will continue to meet standards recommended by WHO; (c) any Contraceptive Devices are fit for any particular purpose; and/or (d) any Contraceptive Devices have obtained regulatory approval(s) for their specified use or any other use in any country, or that their use is in accordance with any laws, rules or regulations of any country (including, but not limited to, patent laws).

7.  WHO hereby disclaims any and all liability and responsibility for any injury, death, loss, damage or other prejudice of any kind whatsoever that may arise from or in connection with this list and/or the procurement, use or distribution of any Contraceptive Devices included in this list.  

8.  Any Member States, UN agencies, international or intergovernmental organizations and/or other third parties that use or intend to use this list in connection with their procurement decisions: (a) do so at their own risk, and (b) should perform other aspects of qualification prior to purchasing/procurement including, but not limited to, verifying the manufacturer’s/supplier’s financial stability, standing and ability to supply the required quantities, as well as verifying the registration status of the products to be procured; and (c) acknowledge that the improper storage, handling and transportation of Contraceptive Products may adversely affect their quality, safety and/or efficacy. 

9.  This list may not be used by any manufacturers, suppliers or other third parties for any commercial, publicity or promotional purposes.    

10. This list does not constitute any commitment or guarantee regarding the procurement of any Contraceptive Devices or from any manufacturers in this list.