Page 156 - SAMRC Annual Report 2023-24

Innovation African Medtech Conference (TAMC) which was
held in Nairobi, Kenya during August 2023, where
Innovation is supported by GIPD both internally and
externally. The unit manages funding programmes enabling policies and their implementation were
aimed at delivering new health solutions, including highlighted. The SAMRC’s contribution revolved
the SHIP programme and Grand Challenges around the initiatives that South Africa is leading to
South Africa. It also hosts the SAMRC’s Technology support the development of medical technologies.
Transfer Office (TTO), the Global Health Innovation The South African government’s pivotal role in
Accelerator (GHIA) and the Medical Device and investment, growth and the evolution of the medical
Diagnostic Innovation Cluster (MeDDIC), all of which technologies sector was highlighted.
provide innovation support to protect and advance
technologies towards commercialised products to MeDDIC
address strategic goal 3 of the SAMRC. The Medical Device and Diagnostic Innovation
Cluster (MeDDIC) is a national initiative supported
Technology Transfer Office by the Technology Innovation Agency and the
The SAMRC’s Technology Transfer Office is Department of Science and Innovation to stimulate
responsible for managing the SAMRC’s compliance and intensify technology innovation within the
with the Intellectual Property Rights from the Publicly medical devices and diagnostic sector as well
Financed Research and Development Act. Its as encourage an integrated health innovation
primary mandate is to identify, evaluate, protect and, ecosystem. The cluster is seeking to address some
where possible, commercialise Intellectual Property of the main challenges faced by the medical devices
(IP) developed by SAMRC researchers and to raise and diagnostics innovation and manufacturing
awareness of IP issues within the organisation. The sector through a range of interventions as outlined
TTO also advises on IP issues in contracts with below.
external parties. One new invention disclosure was
received during 2023/24 financial year. This disclosure Support to SAHPRA for a medical devices database.
The South African Health Products Regulatory
relates to a product which reduces the leaching of Authority (SAHPRA) is responsible for regulating the
chemicals into food in traditional cooking methods manufacture, import, export, distribution and sale of
that continue to be used in LMICs.
medical devices in South Africa and all organisations
undertaking such activities are required to apply to
Global Health Innovation Accelerator
SAHPRA for an establishment license with a list of
GHIA is a partnership between the SAMRC products. These applications have been received
and PATH aimed at facilitating the late-stage manually since the inception of the regulations,
development and introduction of affordable and which has inadvertently resulted in discrepancies
appropriate technologies in South Africa and Africa in the information received across the suite of
more broadly. GHIA’s activities include managing a establishment licences and challenges in capturing
portfolio of product development projects aimed at and analysing the data. Funding was provided to
developing new solutions for global health as well as SAHPRA to capture the product data electronically
broader health innovation ecosystem development. and to assess the existing information gaps and
GHIA encompasses the original partnership with identify areas of improvement that will be used
PATH, largely funded by a grant from the BMGF, when implementing a digital system in the future.
the Medical Device and Diagnostic Innovation This work is now complete and several information
Cluster (MeDDIC) programme, funded by TIA with gaps and opportunities for improvement have been
funds from the DSI, and the SAMRC-TIA Seed Fund identified. The project has also assisted SAHPRA
programme. GHIA is also expanding its network to identify the types of medical devices circulating
and activities into other countries in sub-Saharan in the market, the groupings according to risk
Africa through a second grant received from the classification, and the additional spares, accessories
BMGF. There have been several engagements and research use-only products. The information
during the 2023/24 financial year with prospective will further be used to finalise the structure of the
innovation partners in East and Southern Africa medical devices and diagnostics registration fees.
and these will be pursued through in-person
engagements in 2024. A representative from the The MeDDIC regulatory support programme is
SAMRC participated in the inaugural Transforming managed by the CSIR Industrial Sensors Impact

154 SAMRC ANNUAL REPOR T 2023-24