UNFPA’s Quality Criteria for Procurement of Copper-bearing Intra-uterine Devices:
UNFPA only procures TCu380A IUDs that comply with the requirements of the most recent edition of the WHO/UNFPA specification for TCu380A IUDs. The specification is published together with a technical basis paper that provides evidence supporting specification requirements.
TCu380A Prequalification Lists
Updated July 2014
The lists are updated regularly and reflect the most recent prequalification information.
WHO/UNFPA Prequalification Programme for TCu380A IUDs:
UNFPA manages the Prequalification Programme for copper-bearing intrauterine devices (IUD) within UN system. The Prequalification Scheme was developed by WHO in 2001 with the support of UN and other partner agencies. WHO delegated the management of this program to UNFPA in 2005, but maintains a normative role in setting the guidelines and the requirements. The prequalification process, based on international ISO standards and WHO/UNFPA specification guidelines, entails the following:
- Response to an Expression of Interest (EOI) by applicant. The EOI is posted on the United Nations Global Marketplace (www.ungm.org)
- Submission of required documents by applicant
- Review of submitted documents by technical experts
- Inspection of the manufacturing facility by certified inspectors
- Sampling and testing of products by an independent, ISO 17025 accredited laboratory
- Continuous quality monitoring
- Re-qualification every three years
Products and their associated manufacturing sites that have successfully completed the prequalification process are included in the prequalification list and eligible to bid for UNFPA tenders.
The TCu380A Intrauterine Contraceptive Device (IUD): Specification, Prequalification and Guidelines for Procurement:
The publication contains detailed information on the WHO/UNFPA specification and prequalification process for the TCu380A IUD. The guideline highlights key issues that are relevant to applying a technically sound, systematic process to support the manufacture, prequalification, testing, procurement and distribution of the products and is intended for any policy maker, programme manager or procurement officers who have the responsibility for supplying or promoting intrauterine devices.
The United Nations Population Fund (UNFPA) in collaboration with the World Health Organization (WHO) is the in the process of revising the document, The TCu380A Intrauterine Contraceptive Devices (IUD): Specification, Prequalification and Guidelines for Procurement, 2010. Once the revision process is completed, the updated document will be made available on the website of WHO and UNFPA. Queries regarding the revision process or feedback on the current version should be directed to email@example.com.
Do you have questions or feedback on the WHO/UNFPA Specification for TCu380A IUDs or prequalification process? We want to hear from you! Send us an email firstname.lastname@example.org