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 ...
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.