What's new

Quality Assurance for Health Products

2 September 2024

The revised Quality Assurance for Health policy and procedures result from valuable lessons learned from implementing the 2018 policy version during the height of the COVID-19 pandemic. It serves to assure the safety of all health products procured by UNDP, in line with international best practices. The significant changes in the revised policy include the following: ...

The revised Quality Assurance for Health policy and procedures result from valuable lessons learned from implementing the 2018 policy version during the height of the COVID-19 pandemic. It serves to assure the safety of all health products procured by UNDP, in line with international best practices. The significant changes in the revised policy include the following:

1.    Requirements for PPE, in-vitro diagnostics, and medical gas systems.
2.    Recognition of market clearances and manufacturer certificates issued by Conformity Assessment Bodies that are members of the International Accreditation Forum for Class A medical devices.
3.    Roles and responsibilities of the UNDP QA in CO/RBx managed procurement
4.    Establish a committee to conduct risk-benefit assessments of health products in complex situations.
4.    Recognition of QA approvals made by other UN agencies and other international organisations.
5.    Requirements for emergency assessments and approvals in response to pandemics declared by WHO and levels of crises declared by UNDP.
5.    Clarifies requirements for the use of Research Use Only products used in medical laboratory settings.
6.    Recognition of health product market authorisation and other regulatory activities of WHO Listed National Regulatory Authorities.
7.    Recognition of health product market authorisation and other regulatory activities of National Regulatory Authorities with WHO maturity Level 3 and 4 in specific conditions.

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Contract Management | General Considerations of Contracting | Handling of Procurement Complaints | Payment and Taxes | Shipping and Insurance | Construction Works | Evaluation of Offers | Pre-Award Negotiations | Individual Contract | Engaging CSO/NGO as a Responsible Party | Innovation Challenges | Quality Assurance for Health Products | Long Term Agreements (LTAs) and Cooperation with UN Entities | Procurement Methods | Procurement Authority and Increased Delegated Procurement Authority | Procurement Ethics, Fraud and Corrupt Practices | Procurement Overview and Principles | Sustainable Procurement | Procurement Oversight and Procurement Review Committees | Procurement Forecasting and Delivery | Transactional Procurement Strategies and Procurement Planning | Requisition and Procurement of Goods, Civil Works and Services | Solicitation | Submission and Receipt of Offers | Use of Online Quantum System | Sourcing and Market Research | Vendor Sanctions

Contract Management | General Considerations of Contracting | Handling of Procurement Complaints | Payment and Taxes | Shipping and Insurance | Construction Works | Evaluation of Offers | Pre-Award Negotiations | Individual Contract | Engaging CSO/NGO as a Responsible Party | Innovation Challenges | Quality Assurance for Health Products | Long Term Agreements (LTAs) and Cooperation with UN Entities | Procurement Methods | Procurement Authority and Increased Delegated Procurement Authority | Procurement Ethics, Fraud and Corrupt Practices | Procurement Overview and Principles | Sustainable Procurement | Procurement Oversight and Procurement Review Committees | Procurement Forecasting and Delivery | Transactional Procurement Strategies and Procurement Planning | Requisition and Procurement of Goods, Civil Works and Services | Solicitation | Submission and Receipt of Offers | Use of Online Quantum System | Sourcing and Market Research | Vendor Sanctions

EXPAND

11 March 2021

The following procurement documents are now available in the POPP templates library:Model Contract for Rental of Vehicle with DriverModel Contract for Rental of Vehicle with Driver (Spanish)Model Travel Agency AgreementModel Travel Agency Agreement (Spanish)Model Contract for Security ServicesModel Contract for Security Services (Spanish)Model Contract for Reprints (Spanish)Model Basic Publishing Contract (Spanish)Model Contract for Publication Services

Engaging CSO/NGO as a Responsible Party

12 January 2021

Innovation, CSO engagement

The Engaging CSO/NGO as a Responsible Party policy is now available in French. To access the document, click on the French language tab.

Innovation Challenges

7 July 2020

Innovation, CSO engagement

The Innovation Challenges Agreement Template (Company) is now available in Spanish in the template library (POPP-11-3271). It is also linked in step 9 of theInnovation Challenges procedure table, section 3.0.

Innovation Challenges

7 July 2020

Innovation, CSO engagement

The Innovation Challenges policy is now available in Spanish. To access the content, click on the Spanish language tab.

General Considerations of Contracting | Handling of Procurement Complaints | Payment and Taxes | Shipping and Insurance | Engaging CSO/NGO as a Responsible Party | Requisition and Procurement of Goods, Civil Works and Services

General Considerations of Contracting | Handling of Procurement Complaints | Payment and Taxes | Shipping and Insurance | Engaging CSO/NGO as a Responsible Party | Requisition and Procurement of Goods, Civil Works and Services

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23 June 2020

Award and Management of Contract | Innovation, CSO engagement | Requisition

The following policies are available in Spanish. To access the content, click on the Spanish language tab of the respective policy page:General Considerations of Contracting Handling of Procurement Complaints Payment and Taxes Shipping and Insurance Engaging CSO/NGO as a Responsible Party Security Charges to Individual Contracts (located under "Related Policies" on the Individual Contract policy page, section 2.0)