Medical Device Manufacturers of South Africa (MDMSA)

MDMSA’s move towards independence will provide greater support for med-tech manufacturing ecosystem in South Africa

The executive team of the Medical Device Manufacturers of South Africa (MDMSA), an association of companies that manufacture medical devices in South Africa have decided to become independent of The South African Medical Device Industry Association (SAMED).

The move will provide greater value-added services to its members and align the association more closely with the goals and objectives of MDMSA’s key stakeholders in government and ensuring local manufacturers move towards being ready for export markets.

  • the Department of Trade, Industry and Competition (dtic)
  • the South African Medical Research Council (SAMRC)
  • the National Department of Health (NDoH), the Department of Science and Innovation (DST), and many other organisations that are crucial to the rollout of the Health Products Master Plan (HPMP)
  • Funding for crucial certifications include CE, FDA and ISO13485

The industrialisation and localisation of this sector are vital to the planned National Health Insurance (NHI) programme which will support local manufacturers in South Africa. According to a recent online article the majority of South Africa’s medical device manufacturers’ use only between 25 per cent and 75 per cent of their production capacity. South Africa is one of the largest medical device markets in the Middle East and Africa. Government offers incentives for technology-focused businesses, including an R&D tax credit1.

“MDMSA has redefined the purpose and direction of local manufacturing in South Africa in order to provide members with an opportunity to move towards greater independence,” says Simone Rudolph-Shortt, Chairperson, MDMSA. “Having begun discussions with SAMED in 2019 with regards to a future independent structure, MDMSA now officially embark on this journey with the intention of continued work with SAMED and a number of other associations in the medical technology arena”. A special resolution meeting with members will convene shortly to discuss the independence of MDMSA.

The role of the MDMSA and recent MDMSA developments

MDMSA acknowledges more than 2,500 medical device stakeholders in South Africa, of which approximately 200 are local manufacturers who employ less than 250 staff each. This SME-dominated section of industry represents a combined turnover of R17 billion2. MDMSA thus aims to provide this industry with a unified and respected voice to champion the use of safe and effective locally manufactured medical devices to deliver affordable high-quality patient outcomes. The value-add benefit of local manufacturing involves the creation of jobs and the contribution to the GDP of South Africa.

MDMSA is committed to the production ecosystem of the South African medical device sector and to addressing matters of industry-wide importance.

MDMSA engages with government, regulators, key industry stakeholders and other industry related associations, both in South Africa and abroad, in order to represent the local medical manufacturing industry and ensure that locally made devices meet international standards and requirements.

“As the representative and voice of local medical device manufacturers in South Africa, we have chosen to create new collaborations and associations locally and internationally in order to develop a world-class manufacturing environment which supports inclusion, diversity, and transformation in the industry,” adds Rudolph-Shortt.

“The MDMSA industrialisation and Innovation committee is tasked with driving an agenda which includes the Health Products Master Plan. Integral to this objective is the need to identify products which are currently being imported but which can be substituted and manufactured by a local entity. To pull together all of the loose ends, MDMSA has signed an MOU with Triangulus Consulting to develop a digital platform for the industry which will provide a toolbox to assist new and existing local manufacturers with the means to easily access research, insights and learnings in support of optimal industrialization and commercialization,”, says Lindsay Curran, MDMSA Chair Industrialisation and Localisation Sub Committee.

MDMSA was instrumental in obtaining sector recognition as a priority sector by the Dtic.

MDMSA Achievements

  1. MDMSA application to the DTI also resulted in sector recognition with government which in turn led to the medical device sector being included in outward selling missions.
  2. Swasthi Soomaroo appointed as the Director for pharmaceutical and medical devices.
  3. MDMSA engaged with various stakeholders such as IDC and Proudly South African.
  4. Approval of Africa Health and Arab Health as National Pavilions.
  5. Successful participation in Dubai World Expo 2020.
  6. MDMSA registration as a Non-profit Company in order to promote Good governance, Accountability, Transparency and to further support local manufacturing efforts.
  7. Continued support for SSAS exhibition programme.
  8. MEDDIC – The medical device development group was established in 2016 and included DST, TIA, DTIC, CSIR, MDMSA and MRC and was administered by GHIA. MEDDIC was a result of all these efforts to stimulate development.

Join the newly independent MDMSA

In the run-up to 2023 and full independence, MDMSA invites existing and potential new members to engage with the association to build a robust leaner, fitter forum that will improve the med-tech sector in South Africa and make a positive contribution to the future of the sector.

MDMSA therefore invites medical device manufacturers to join MDMSA in 2023. We encourage members to be part of more than one association, if possible, as this can lead to greater exposure, as well as the more in-depth experience, skills and networks. Should a manufacturer not wish to join both associations, resignation from SAMED is required by the end of October, otherwise they will be obliged to pay SAMED fees for the following year.

Partnerships with associations and government including collaborative efforts are important to the manufacturing sector in South Africa. Government also plays a role and, as an example the Department of Science and Innovation (DSI) has officially unveiled a R97 million 3D printing project to improve access to medical devices for people living with disabilities. The DSI launched the project − called the Medical Device Additive Manufacturing Technology Demonstrator (MedAdd) − in partnership with Central University of Technology (CUT), as well as its Technology Innovation Agency (TIA) 3. These initiatives can strengthen the sector and it’s important for companies, associations and government to work together.

Joining MDMSA offers focussed, localised support regarding regulations, collaboration with significant stakeholders, navigation of technical documentation, and links to relevant ecosystem service providers. MDMSA has shaped its structure using sub-committees with member volunteer participation to enable a cohesive approach to growing local production of South African medical devices for the local and export markets. Dtic has now taken the role of organising the National Pavilion. MDMSA’s work focuses on the South African market, ethics and compliance, international business development and the regulation of medical devices. This includes exhibitions and export opportunities.

According to a recent report, investments in medical device R&D is low, the report says, amounting for less than 1 per cent of turnover of companies in the sector. This is way below the global average of 6.8 per cent1. In addition, government incentives aren’t taken up. Less than 10 per cent of the companies that reported carrying out research had claimed tax credits, the report found1.

“Only by taking positive steps in the right direction can we achieve our objective of realising a new vision for the med-tech sector in South Africa,” says Rudolph-Shortt.” We look forward to the support and commitment of the local manufacturers as we move into this exciting new phase.” We would like to thank SAMED for their support from inception of MDMSA through to the present and acknowledge the role that they have played in providing the resources that have enabled MDMSA’s work in the industry thus far.