Consultancy Service to Develop a Continental Regulatory Process for Certification or Listing of Priority In-Vitro Diagnostics (IVDs) (ЮАР - Тендер #53331320)

Tender Summary Issuer: Africa Union Development Agency - New Partnership for Africa’s Development (AUDA-NEPAD) Tender reference: 57/AUDA/HCID/ID/ICS/2024 Sector: Medical ServicesResearch, Consultancy and Professional Services Closing Date: Monday, May 6, 2024 - 14:30 Issue Date: Tuesday, April 23, 2024 - 10:00 Region: Eastern CapeGautengKwaZulu NatalLimpopoNorth WestNorthern CapeWestern CapeMpumalangaFree State
Tender Description

Consultancy Service to Develop a Continental Regulatory Process for Certification or Listing of Priority In-Vitro Diagnostics (IVDs)

Tender number: 57/AUDA/HCID/ID/ICS/2024

Closing date and time: MAY 6th, 2024 14:30 hours

1. INTRODUCTION
The African Union Development Agency (AUDA-NEPAD) was established in 2019 following the decision taken at the 31st Ordinary Session of the Assembly of African Union Heads of State and Government in Nouakchott, Mauritania, July-2018. AUDA-NEPAD is mandated to:
a) Coordinate and execute priority regional and continental projects to promote regional integration towards the accelerated realisation of Agenda 2063;
b) Strengthen the capacity of the African Union’s Member States and regional bodies;
c) Advance knowledge-based advisory support;
d) Undertake the full range of resource mobilisation; and
e) Serve as the continent’s technical interface with all Africa"s development stakeholders and development partners.

2. SCOPE/MAIN RESPONSIBILITIES OF THE ASSIGNMENT
The Consultant shall deliver on the following tasks:
• Develop the Continental Overarching Procedure for Certification or Listing of IVDs
• Align the African Technical Guidance for Industry on Submission of Data for Certification of Priority IVDs to the WHO Technical Specification Series, Technical Guidance Series
• Develop Application Forms and Checklists and CLSI Guidelines and Standards
• Develop a continental Compendia of Standard Operating Procedures (SOPs) for Certification of Priority IVDs
• Develop an implementation roadmap for the Continental Overarching Procedure

Interested consultants may obtain further information from the address listed below. All Expression of Interests should be sent electronically to email listed below.

10. Expressions of interest must be delivered to the address below by email on or before MAY 6th, 2024 14:30 hours (South African Time). All EOI’s must be marked “57/AUDA/HCID/ID/ICS/2024– Consultancy Service to Develop a Continental Regulatory Process for Certification or Listing of Priority In-Vitro Diagnostics (IVDs)” in the subject line of the email.

The Chairperson Internal Procurement Committee (IPC)
AUDA-NEPAD
230, 15th Road, P. O. Box 218 Midrand,
1685 Johannesburg, South Africa
Email: procurement@nepad.org & copy ngonik@nepad.org
Attention of: Head of Procurement Division

see documents for more details

see: https://www.sa-tenders.co.za/sites/default/files/request_for_expression_...

https://www.sa-tenders.co.za/sites/default/files/terms_of_reference_-_co...

Attachments: request_for_expression_of_interest_consultancy_service_to_develop_a_continental_regulatory_process_for_certification_or_listing_of_priority_in-vitro_diagnostics_ivds.pdf terms_of_reference_-_consultancy_for_the_african_ivds_certification_procedure.pdf

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