Page 182 - SAMRC Annual Report 2024-2025

device's portal within the national Innovation Bridge
portal (see below).

In 2023/24, the GHIA team launched a new Technical
Support Platform aimed at bridging the gap MeDDIC
between the identified need for technical support The Medical Device and Diagnostic Innovation
by medical device and diagnostics developers/ Cluster (MeDDIC) is a national initiative supported
innovators and the experienced limited access to by the Technology Innovation Agency and the
the relevant resources and infrastructure that can Department of Science, Technology and Innovation
enable commercialization of their products. The to stimulate and intensify technology innovation
Platform aims to, inter alia, provide a consolidated within the medical devices and diagnostic sector as
network of locally available technology, expertise well as encourage an integrated health innovation
and platforms for medical device and diagnostics ecosystem. The cluster is seeking to address some
development, testing, registration, manufacturing of the main challenges faced by the medical devices
and commercialization. A call for expressions of and diagnostics innovation and manufacturing sector
interest from service providers in September 2023 through a range of interventions as outlined below.
resulted in submissions from more than 50 service
providers who were invited to present at Medical The MeDDIC regulatory support programme is
Devices and Diagnostics Technical Support – managed by the CSIR Industrial Sensors Impact
Service Providers Pitching Sessions held virtually Area within the manufacturing cluster due to their
from 22 – 24 November 2023. The innovation team ISO13485 certification and extensive experience in
has developed an interactive stakeholder database medical device and diagnostic development. It is
for all companies involved in the medical devices aimed at assisting local companies, entrepreneurs,
and diagnostics space, and this will be launched and higher education institutions to understand and
in 2025. Following the pitching session, projects manage the medical device product development
previously funded through the SAMRC (including process, particularly as it relates to regulations.
those supported through GHIA) were invited to This programme was awarded additional funds in
respond to a closed call for funding applications to 2024/5 to continue providing assistance with the
utilize any of these services to further their product regulatory process, including product development
development and commercialization. From this call, in the context of ISO13485, classification of medical
6 proposals were approved for funding during 2024. devices and related standards. This programme has
been very successful in filling a gap in regulatory
A second grant from the BMGF that was also information and expertise for small companies
completed in 2024 was aimed at continuing and entrepreneurs. To date it has supported 19
and expanding some of the GHIA activities and organisations/individuals with SAHPRA device
especially exploring expansion of the GHIA classification, ISO standards, technical support
concept and activities elsewhere in Africa. for device testing from SABS and CSIR, SAHPRA
Following desktop landscape analysis of the technical file requirements and SAHPRA registration.
health innovation ecosystems in Uganda, Kenya, Where applicable, some companies were also linked
Ghana, Malawi, Botswana, Namibia and Tanzania, to other funding organisations and/or instruments
the Innovation Programme Manager, Grace such as the DTIC.
Baloyi, conducted in-country engagements to
identify champions to design context-specific The MeDDIC online platform, launched in February
GHIA models that can be implemented in Kenya 2023, leverages off the national Innovation Bridge
and Uganda. She also participated in the second Portal, an initiative of the DSTI, developed by the
instalment of the Transforming African MedTech CSIR and supported by the World Bank Group and
Conference, a platform aimed at building a vision the Department of Small Business Development,
for a comprehensive and transformative African which is aimed at showcasing technology
medical technology industry. Various opportunities innovations and opportunities from South Africa
for innovation collaboration were identified in both and beyond. The dedicated medical devices portal
countries and will be pursued subject to raising within the Innovation Bridge has been developed
additional funding. to include medical device manufacturers, R&D

180 SAMRC ANNUAL REPOR T 2024-25