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Functional Areas
- Audit and Investigations
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Capacity development and transition, strengthening systems for health
- A Strategic Approach to Capacity Development
- Capacity Development and Transition - Lessons Learned
- Capacity development and Transition Planning Process
- Capacity Development and Transition
- Capacity Development Objectives and Transition Milestones
- Capacity Development Results - Evidence From Country Experiences
- Functional Capacities
- Interim Principal Recipient of Global Fund Grants
- Legal and Policy Enabling Environment
- Overview
- Resilience and Sustainability
- Transition
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Financial Management
- CCM Funding
- Grant Closure
- Grant Implementation
- Grant-Making and Signing
- Grant Reporting
- Overview
- Sub-recipient Management
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Grant closure
- Overview
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Steps of Grant Closure Process
- 1. Global Fund Notification Letter 'Guidance on Grant Closure'
- 2. Preparation and Submission of Grant Close-Out Plan and Budget
- 3. Global Fund Approval of Grant Close-Out Plan
- 4. Implementation of Close-Out Plan and Completion of Final Global Fund Requirements (Grant Closure Period)
- 5. Operational Closure of Project
- 6. Financial Closure of Project
- 7. Documentation of Grant Closure with Global Fund Grant Closure Letter
- Terminology and Scenarios for Grant Closure Process
- Human resources
- Human rights, key populations and gender
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Legal Framework
- Agreements with Sub-sub-recipients
- Amending Legal Agreements
- Implementation Letters and Management Letters
- Language of the Grant Agreement and other Legal Instruments
- Legal Framework for Other UNDP Support Roles
- Other Legal and Implementation Considerations
- Overview
- Project Document
- Signing Legal Agreements and Requests for Disbursement
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The Grant Agreement
- Grant Confirmation: Conditions Precedent (CP)
- Grant Confirmation: Conditions
- Grant Confirmation: Face Sheet
- Grant Confirmation: Limited Liability Clause
- Grant Confirmation: Schedule 1, Integrated Grant Description
- Grant Confirmation: Schedule 1, Performance Framework
- Grant Confirmation: Schedule 1, Summary Budget
- Grant Confirmation: Special Conditions (SCs)
- Grant Confirmation
- UNDP-Global Fund Grant Regulations
- Monitoring and Evaluation
- Principal Recipient Start-Up
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Procurement and Supply Management
- Development of List of Health Products and Procurement Action Plan
- Distribution and Inventory Management
- Overview
- Price and Quality Reporting (PQR) System
- Procurement of Non-health Products and Services
- Procurement of Pharmaceutical and Other Health Products
- Quality Control
- Rational use of Medicines and Pharmacovigilance Systems
- Strengthening of PSM Services and Risk Mitigation
- UNDP Health PSM Roster
- UNDP Quality Assurance Policy and Plan
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Reporting
- Communicating Results
- Grant Performance Report
- Overview
- Performance-based Funding and Disbursement Decision
- PR and Coordinating Mechanism (CM) Communication and Governance
- Reporting to the Global Fund
- UNDP Corporate Reporting
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Risk Management
- Common Risks Identified in Global Fund Programmes
- Global Fund Risk Management
- Introduction to Risk Management
- Overview
- Risk Management in High Risk Environments
- Risk Management in UNDP-managed Global Fund Grants
- Risk management in UNDP
- UNDP Risk Management in the Global Fund Portfolio
- Sub-Recipient Management
Diagnostic Products and Medical Devices
Diagnostic Products
Diagnostic products procured with Global Fund resources must adhere to the Global Fund Quality Assurance (QA) Policy for diagnostic products, issued on 14 December 2010 and most recently amended on 4 May 2017.
Diagnostic products mean all durable and non-durable in-vitro diagnostic products (IVD), imaging equipment and microscopes used for diagnosis, screening, surveillance or monitoring purposes.
Quality standards for diagnostic products
Section 7 of Global Fund QA Policy[1] for diagnostics states that Grant Funds may only be used to procure diagnostic products that meet the following standards:
- IVDs and imaging equipment manufactured at a site compliant with the requirements of ISO 13485 or an equivalent quality-management system recognized by one of the regulatory authorities of the Founding Members of GHTF[2]; and
- any diagnostic product for which Section 7 (i) above does not apply, such as microscopes, manufactured at a site compliant with all applicable requirements of the ISO 9000 series or an equivalent quality-management system recognized by one of the regulatory authorities of the founding members of GHTF.
Section 8 of the Global Fund QA Policy for diagnostics states that, in addition to the requirements of Section 7 above, diagnostics products with regards to HIV, tuberculosis and malaria and to hepatitis B, hepatitis C and syphilis co-infections, as well as IVDs providing information that is critical for patient treatment of these diseases, such as testing for G6PD deficiency, shall meet any one of the following standards:
- prequalification by the WHO Prequalification of In Vitro Diagnostics Programme; or
- for tuberculosis: recommendation by relevant WHO programme; or
- authorization for use by one of the Regulatory Authorities of the Founding Members of GHTF when stringently assessed (high risk classification)[3]; or
- acceptability for procurement using Grant Funds, as determined by the Global Fund, based on the advice of the WHO Expert Review Panel.
The quality assurance page on the Global Fund website provides further guidance on QA requirements and how to ensure that the most recent version of documents and templates are used.
UNDP technical and regulatory requirements for IVDs
The UNDP Quality Assurance (QA) policy[4] aligns with the requirements outlined in the Global Fund QA policy. Within the UNDP QA framework, the qualification process encompasses key stakeholders: the supplier, manufacturing site(s), and product. A crucial aspect of the evaluation relies on the information submitted by the bidders. The technical and regulatory requirements outlined for in vitro diagnostic products[5] guide bidders to adhere to UNDP’s QA policy. The requirements cover all the different risk classifications of IVDs based on the IMDRF classification, from low risk to high risk.
Some examples of in vitro diagnostic device classification [4,6,7] are listed in the below table. However, these examples are for general understanding, and the actual classification of a specific device must be considered individually, taking account of its design, and intended use.
Medical Devices (MDs)
Medical devices procured by UNDP must adhere to the requirements set out in the UNDP QA policy [4]. The UNDP QA system for medical devices is based on the guidelines of the International Medical Devices Regulator Forum (IMDRF) for Medical Devices[2]. It also aligns with QA policies from other UN agencies and international organizations such as The Global Fund [1,8].
UNDP technical and regulatory requirements for MDs
Within the UNDP QA framework, the qualification process encompasses key stakeholders, namely the supplier, manufacturing site(s), and the product. A crucial aspect of the evaluation relies on the information submitted by the bidders. The technical and regulatory requirements outlined for medical devices [9] guide bidders to comply with UNDP’s QA policy. This document specifies the criteria that UNDP utilizes in the procurement process for medical devices. The requirements cover all the different risk classifications of medical devices based on the IMDRF medical devices classification, from low risk to high risk.
Some examples of medical device classification [10] are listed in the table below. The actual type of each device depends on the manufacturer’s claims and intended use. However, these examples are for general understanding, and the precise classification of a specific device must be considered individually, considering its design and intended use.
[1] Quality Assurance of Diagnostic Products
[2] GHTF—the Global Harmonization Task Force—has now been replaced by IMDRF—the International Medical Devices Regulators Forum (conceived in February 2011). IMDRF members are: Australia, Brazil, Canada, China, European Union, Japan, the Russian Federation and the United States. IMDRF observers are: WHO and Asia-Pacific Economic Cooperation (APEC). IMDRF affiliates are: Asian Harmonization working party and the Pan American Health Organization (PAHO). For further information, see: http://www.imdrf.org/
[3] This option is not applicable to RDTs for HIV-Self-Testing.
[4] QA_policy_Health_Products.pdf (undp.org)
[5] UNDP Technical & Regulatory Requirements for In Vitro Diagnostic Devices (IVDs)
[6] Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (imdrf.org)
[7] IVD Risk-based Classification | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
[8] Guide to Global Fund Policies on Procurement and Supply Management of Health Products, June 2021 (theglobalfund.org)
[9] UNDP Technical & Regulatory Requirements for Medical Devices
[10] GHTF SG1 Principles of Medical Devices Classification - November 2012 (imdrf.org)