Page 186 - SAMRC AnnualReport 2025-26

MeDDIC › MeDDIC supported a small portfolio of four
localisation projects aimed at increasing the
The Medical Device and Diagnostic
Innovation Cluster (MeDDIC) is a nationwide locally manufactured content of medical devices
initiative established in 2021, supported and IVDs that were largely imported, with the
by the Technology Innovation Agency and goal of reducing the trade imbalance and the
the Department of Science, Technology country’s reliance on imports. All four products
and Innovation. Its aim is to stimulate and have been taken up in the market, and the host
strengthen technological innovation in the companies now hold SAHPRA-approved licences
medical devices and diagnostics sector, as well to manufacture.
as promote an integrated health innovation › MeDDIC has funded a regulatory support
ecosystem. The first phase of MeDDIC, which programme, managed by the CSIR Industrial
lasted five years, was completed in March 2026. Sensors Impact Area within the manufacturing
During this period, MeDDIC made significant cluster, aimed at assisting local companies,
progress in addressing challenges within entrepreneurs, and higher education institutions
the medical devices and diagnostics sector, to navigate the medical device compliance and
efficiently utilising limited resources through registration requirements. More than 20 companies,
the activities listed below. institutions and individual entrepreneurs have
been assisted through this mechanism.
› SAHPRA received a direct grant to collect
and analyse data from medical device and › A Medical Devices and Diagnostics Technical
IVD establishment licenses. This helped Support Platform was created to improve access
identify license holders and the types of to local technology, expertise, and platforms for
devices circulating in South Africa. SAHPRA development, testing, registration, manufacturing,
will use this data to prepare for registration of and commercialization of medical devices and
individual device categories. diagnostics. After a September 2023 Request
for Information, over 50 responses from service
› MeDDIC hosted the Medical Devices providers were received, all invited to present at
Stakeholder Forum (MDSF), holding MDSFs held virtually from 22–24 November 2023.
meetings during phase 1 for information An Interactive Stakeholder Map listing available
sharing, networking, coordination, and technologies, platforms, capabilities, and service
discussion of industry challenges. The MDSF providers in South Africa's medical tech sector was
also facilitated stakeholder engagement with developed. A closed call for projects previously
SAHPRA on sector-specific regulatory issues. funded by the SAMRC was conducted to utilise
› Stakeholder collaboration and information these services for product development and
sharing were facilitated by the Innovation commercialization. Six applications were approved
Bridge Medical Devices portal (https:// for funding and are now in progress.
innovationbridge.info/ibportal/meddic), › MeDDIC is piloting an internship programme
launched by the CSIR in February 2023 placing science graduates in medical device
within the national Innovation Bridge portal. companies, science councils, and academic units
It includes sections for manufacturers, involved in certification processes. It aims to provide
R&D, support, funding, innovations, and hands-on training in industry environments
opportunities, allowing for the showcasing to boost skills in regulatory compliance for
of capabilities, partnerships, licensing, and medical devices and diagnostics. A request for
funding to boost local device production and expressions of interest from host companies was
sector collaboration.

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