Consultancy to Conduct Training Needs Assessment (TNA) on Premarket Assessment of Medical Devices and in-Vitro Diagnostics (Market Authorization Function) and Develop a Training Strategy - 2925908

The AFRICAN UNION DEVELOPMENT AGENCY (AUDA-NEPAD) in South Africa from African region had released this tender for Tenders are invited for Consultancy to Conduct Training Needs Assessment (TNA) on Premarket Assessment of Medical Devices and in-Vitro Diagnostics (Market Authorization Function) and Develop a Training Strategy for National Regulatory Authorities in Africa. Closing Date: Friday, March 31, 2023 - 14:30 Sector: Education and Training Description: Consultancy to conduct training needs assessment (TNA) on premarket assessment of medical devices and in-vitro diagnostics (market authorization function) and develop a training strategy for national regulatory authorities in Africa Tender number: 37/AUDA/DPDC/HCID/ICS/2023 Closing date and time: March 31st, 2023  at 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: Coordinate and execute priority regional and continental projects to promote regional integration towards the accelerated realisation of Agenda 2063; Strengthen the capacity of the African Union’s Member States and regional bodies; Advance knowledge-based advisory support; Undertake the full range of resource mobilisation; and Serve as the continent’s technical interface with all Africa's development stakeholders and development partners. As part of p re market phase, National Regulatory Authority (NRA) assesses information/evidence submitted the manufacturers of medical devices, including in-vitro diagnostic devices (IVDs), to verify safety and performance. compliance with NRAs are expected to develop and align their assessment requirements based on internationally recognized guidelines and standards as defined by the African Medical Devices Forum, World Health Organization (WHO), International Medical Device Regulators Forum (/IMDRF), International Organization for Standardization (ISO) standards and Clinical Laboratory Standards International guidelines to mention a few. The assessment of the medical device by the NRA can cover all regulatory components, i.e. technical file, manufacturing site audit and performance evaluation or clinical investigation. This type of assessment is usually extensive and requires sound technical expertise which often lack in many resource limited settings. Abridged assessment using reliance and recognition principles as elaborated in WHO global model regulatory framework for medical devices including in-vitro diagnostic medical devices (GMRF) and the Collaborative Registration Procedure (CRP) may be considered when such products are being assessed by WHO or a reference NRA. Nevertheless in abridged assessment, the assessment reports from the reference NRA or WHO needs to be reviewed considering country specific requirements such as stability study conditions and labelling. Reliance and recognition also requires some level of knowledge and skills to be able to have confidence on the recommendation to issue MA or not. Training by reference NRAs, International Organizations such as the WHO and training institutions is regarded as one of the very critical element in addressing technical challenges facing most countries. In this respect a systematic approach of prioritizing areas for capacity building and training is expected to be undertaken through training needs assessment exercise in the pre-market phase of medical devices and IVDs regulation (i.e., registration and marketing authorization). 2. OBJECTIVES OF THE ASSIGNMENT The main objective of this assignment is to support Member States and AMDF in identifying priority areas for training in the pre-market phase of regulation of medical devices including IVDs. Specifically the consultancy has the following objectives: a. To develop a training needs assessment tool including the required expertise and competencies b. To apply the tool - through the NRAs- to identify gaps in knowledge and skills among premarket personnel (assessors) of NRAs from countries in Africa for effective assurance of quality, safety and performance of medical devices and IVDs being issued with marketing authorization and registration in the countries. c. To develop a training strategy for AMDF TC for pre-market activities. d. From the training strategy: recommend training programme package for imparting knowledge, competencies and skills identified 3. SCOPE/MAIN RESPONSIBILITIES OF THE ASSIGNMENT: The Consultant shall carry out the following tasks: a. Define the eligibility criteria for selection of two countries from each REC to be involved in the TNA process. b. Undertake in-depth analysis of the current pre-market assessment skills and expertise needed in the pre-market assessment of medical devices and specifically IVDs. c. Acknowledge different product categories. d. Develop a tool to carry out a human resource analysis and assess the (immediate) training requirements. e. Detail the skills and competency gaps. f. Develop a training needs assessment tool g. Determine the NRAs benefits of TNA and ensure the NRAs understands them. h. Provide support to AMDF in identifying key stakeholders to be engaged in the TNA process. i. Recommend the most suitable means of improving the knowledge and skills bases of NRAs personnel to enhance their ability to discharge their responsibilities. j. Identify outline training modules for improving knowledge and skills. k. Recommend a suitable training programme for the personnel involved. l. Recommend any relevant short-, medium- and long-term courses tenable locally or abroad. m. Draw up a model budget and other resource requirements for meeting the training programme, and for any retooling necessary. n. Organise a validation and dissemination workshop through AMDF. o. Make any other recommendations to enhance the skills base of NRA staff. p. To develop a TNA report and submit to AMDF TC 4. DELIVERABLES The Consultant shall submit the following: Inception Report: to be submitted within 7 days from start of assignment. Progress Reports: to be submitted on bi-weekly basis. Draft TNA Report: to be submitted within 60 days from start of assignment. Draft TNA Report: to be discussed in the AMDF TC Final Report: to be submitted within 90 days from start of assignment 5. AUDA-NEPAD now invites eligible individual consultants (“Consultants”) to indicate their interest in providing the Services. Interested Consultants should provide information demonstrating that they have the required qualifications and relevant experience to perform the Services. 6. QUALIFICATIONS, EXPERIENCE AND COMPETENCIES Qualifications and Skills A minimum of a Bachelor’s Degree in health sciences specifically in medical laboratory sciences, biomedical engineer, pharmacy, or medicine. Experience At least 7 years as a practitioner or consultant in working in medical device including IVDs regulatory bodies or other relevant area. Experience in matters related to personnel and institutional development, training and/or educational planning is highly preferred. Demonstrated experience in matters related to personnel and institutional development, training and/or educational planning is highly preferred A professional with exposure to international collaboration in medical products regulatory field. Good knowledge on the AMRH Initiative and Africa Medical Devices Forum (AMDF) is essential. 7. SHORTLISTING CRITERIA For evaluation of the expressions of interest, the following criteria will be applied: i) Qualifications, Relevant Training and General Education (30 points); ii) Experience in the Specific Assignment as Described in the TORs (60 points); and iii) Knowledge of the Region & Local Conditions (10 points). A Consultant will be selected in accordance with Individual Consultant Selection (ICS) method set out in the AU Procurement Manual. 8. SUBMISSION REQUIREMENTS Interested candidates are requested to submit the following documents for AUDA-NEPAD consideration: I. Cover letter confirming compliance to eligibility; II. Signed declaration of undertaking (Attached as an annex below);and III. Curriculum Vitae (CV). IV. Proof of stated qualifications in the form of the copies of the degrees obtained 9. REPORTING AND TIME SCHEDULES: I. In undertaking this exercise, the consultant will be expected to frequently exchange and interact with the Programme Officer Resource Mobilization of AUDA-NEPAD. 10. Only Individual Consultants are eligible for this assignment if they fulfil the following eligibility criteria: a) Have no conflict of interest in relationship to performance of this assignment; b) Are not subject to, and not controlled by any entity or individual that is subject to, a temporary suspension or a debarment imposed by the African Union Commission, World Bank or any other multilateral development bank and being listed on the website http://www.worldbank.org/debarr or respectively on the relevant list of any other multilateral development bank. Further, are not ineligible pursuant to a decision of the United Nations Security Council; c) Have not been convicted by a final judgement or a final administrative decision or subject to financial sanctions by the United Nations or Country for involvement in a criminal organisation, money laundering, terrorist-related offences, child labour or trafficking in human beings; this criterion of exclusion is also applicable to legal Persons, whose majority of shares are held or factually controlled by natural or legal Persons which themselves are subject to such convictions or sanctions; d) Are not being bankrupt, wound up or ceasing our activities, having our activities administered by courts, having entered receivership, reorganisation or being in any analogous situation; e) Are not involved in corruption: offering, giving, receiving or soliciting, directly or indirectly, anything of va with tender notice no. 37/AUDA/DPDC/HCID/ICS/2023 published on 20 Mar 2023. The tender expired on 31 Mar 2023. This tender is sourced from Official Website and is eligible for suppliers interested in Medical equipments. Interested bidders can obtain further information including complete bid documents or ways to participate by registering on Tender Impulse and referencing via Tender Impulse ID 2925908.