Prequalification Programme for TCU380A IUD

Prequalification, specifications and guidelines

Publication Date: 2016
Author: UNFPA

Note: The document “TCu380A Intrauterine Contraceptive Device (IUD) WHO/UNFPA Technical Specification and Prequalification Guidance” is currently undergoing revisions.

WHO/UNFPA Prequalification Programme for TCu380A IUDs 

UNFPA manages the Prequalification Programme for copper-bearing intrauterine devices (IUD) within the 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 (UNGM)
• 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.

Please click here for the full list of TCu380A IUD manufacturing sites that have successfully completed the WHO/UNFPA Prequalification Process.

UNFPA Quality Criteria for Procurement of Copper-bearing Intrauterine Devices

UNFPA only procures TCu380A IUDs that comply with the requirements of the most recent edition of the WHO/UNFPA Technical Specification for TCu380A IUDs. The specification is published together with a technical basis paper that provides evidence supporting specification requirements.

The TCu380A Intrauterine Contraceptive Device (IUD) Technical Specification and Prequalification Guidance 2016

The publication contains detailed information on the WHO/UNFPA Technical Specification and the prequalification process for the TCu380A IUD. The guidance document highlights key issues that are relevant to applying a technically sound, systematic process to support the manufacture, prequalification and testing of the products. It is designed to provide manufacturers, procurement agencies, national regulatory authorities, testing laboratories and programme managers with up-to-date information about the TCu380A IUD and to provide a technical specification that is suitable to cover quality management of IUD for bulk procurement. Changes of this revised guidance against the ‘TCu380A Intrauterine Contraceptive Device (IUD): Specification, Prequalification and Guidelines for Procurement 2010’ are discussed and listed in detail.

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