How will the Emergency Evaluation and Listing Process be like? The AMDF will use its platform and resources to bring together the 12 countries reported by the Africa CDC to have been affected and facilitate a collaborative rolling review of technical files for the candidate IVDs to establish their quality, safety and performance. [...] Where and when to submit the EoI? Send the EOI to the following mailbox addresses: amrh@nepad.org cc alexj@nepad.org The window for submissions of EOI is opened from the on 7th September 2024. [...] Where to submit the Application? After the EOI is accepted, all applications and other supporting documents for the purpose of this Emergency Use Listing will be submitted to the South African Health Product Regulatory Authority (SAHPRA) which has been selected by the AUDA NEPAD to receive, process, and manage the application dossiers on behalf of the AMRH in the interim period. [...] Criteria for Decision on an EUL The following criteria for issuing an EUL will need to be met: a) Based on the totality of scientific evidence available b) The known and potential benefits outweigh the known and potential risks of the product when used to diagnose the disease (Mpox) c) The product is manufactured in compliance with ISO13485 QMS standards. [...] d) The applicant undertakes to complete the development including monitoring and reporting of the product and apply for full authorization to the countries.
- Pages
- 5
- Published in
- South Africa
Table of Contents
- INVITATION OF EXPRESSION OF INTEREST TO 1
- MANUFACTURERSDEVELOPERS OF MPOX 1
- DIAGNOTIC TESTS TO A CONTINENTAL 1
- FACILITATED JOINT REVIEW AND EMERGENCY USE 1
- LISTING 1
- 1. INTRODUCTION 2
- 1.1. Invitation to Manufacturers Developers or Duly Authorized Applicants 2
- 1.2. Background 2
- 1.3. The African Medical Devices Forum AMDF 2
- 1.4. How will the Emergency Evaluation and Listing Process be like 3
- 1.5. How is this process linked to Africa CDC Pooled Procurement 3
- 2. SUBMISSION OF EOI 3
- 2.1. Who can Apply 3
- 2.2. What to submit for the EoI 3
- 2.3. Where and when to submit the EoI 3
- 3. SUBMISSION OF TECHNICAL FILES APPLICATION DOSSIER FOR A 4
- COLLABORATIVE EVALUATION THROUGH AMDF-TC 4
- 3.1. Where to submit the Application 4
- 3.2. What are the documents to be supplied and under which format for the 4
- 3.3. Which Type of Products are Eligible. 4
- 3.4. When to apply 4
- 3.5. What fee do I have to pay to participate in the Continental Emergency Use Listing 4
- CEUL 4
- 4. AMDF RECOMMENDATION AND LISTING DIAGNOSTICS TESTS 4
- 4.1. Criteria for Decision on an EUL 4
- 5. SUPPLEMENTARY INFORMATION 5
- 6. CONTACTS 5
- 6.1. AMRH Secretariat 5
- 6.2. SAHPRA 5
