SAMED ANNUAL REPORT
MAY 2023 - MAY 2024
Elevating the agenda of medtech in South Africa
METRICS THAT MATTER
172
Member companies
12
New members
2897
Youth jobs created by 42 members
37
Events hosted
4
Code hotline cases
received and investigated
12
Code advisory opinions provided
2
New innovative platforms launched
Purpose-driven Medtech
During 2023-24, SAMED continued to strengthen our sector’s purpose by driving greater access to medtech, partnering with others to reform healthcare and building economic activity within our industry and South Africa more broadly.
Executive Officer Report
During 2023-24, it became clear that SAMED’s position and recognition have been elevated. This past year has opened a number of doors. We received more invitations to attend and represent the industry on many more forums than ever before, showing that we were determined and successful in pursuing the strategic imperative to elevate medtech and elevate SAMED.
Chairperson’s Report
The biggest thing the SAMED board wanted to achieve this year was inclusion and diversity within the SAMED member collective, our sector and the board where the deliberate appointment of diverse new members has enabled us to shift transformation and governance to the next level.
This emphasis on diversity, inclusion, equality and transformation has showcased our industry as one that is socially in touch which has visibly furthered SAMED’s pursuit of the 2022/23 organisational strategy.
We continued to elevate medtech, partner with key stakeholders, provide value to members and ensure our association and its influence are continually transforming and growing to ensure sustainability of member companies and of the medtech value chain.
The sector’s and SAMED’s contributions to the healthcare sector and health reform were justly recognised by this year’s launch of the MEDTECH Master Plan by the Minister of Trade Industry and Competition, Mr Ebrahim Patel, the medtech industry, agencies of government, representatives from the private sector hospital groups, organised labour, regulatory bodies, pharma, media and private procurers.
Peter Mehlape
SAMED Chairperson
The MEDTECH Master Plan seeks to provide guidance for the public and private sectors to dedicate resources and time to strengthen the sector and place it on a growth trajectory. The milestone embodies the devotion and effort invested by SAMED in research, stakeholder engagement and crafting of the plan, in the belief that it can unite the South African health system to spur medtech towards greater economic prominence and to benefit South African and African patients.
Guided by patient-centricity and commitment to serving healthcare professionals (HCPs) and other customers, we remained involved in policy development, giving special focus to medtech regulations and national health insurance. This discourse reached a crescendo when President Cyril Ramaphosa signed the NHI Act in mid-May and continued to occupy a prominent place in public discourse in the run up to elections.
With the massive outstanding payments owed by government to SAMED members conspicuously at the top of SAMED’s agenda, we used this time to advocate in the media that the newly promulgated NHI Act does not have adequate policies to facilitate the establishment of fundamental administrative functions that can resolve public debt challenges.
This influenced SAMED’s position on NHI which is that it cannot support the implementation of the Act until key administrative functions including human resources and information and communication infrastructure necessary for processing millions of claims, invoices and payments are enabled. These elements are absolutely necessary for the efficient procurement, reimbursement and independent assessment of quality/ efficacy/pricing of health technologies.
Supporting growth for sustainability
When we look at macro-economic and geopolitical forces, medtech localisation, regulatory convergence and harmonisation and other factors that influence medtech industry sustainability and future growth, it becomes clear what a dynamic year is behind us.
I believe that as SAMED, we acted resolutely and quickly when the economic and political complexities threatened to disrupt relations with South Africa’s main trading partners, namely the United States. These could easily have interrupted medtech supply and patient services. However, we were bold in putting our best foot forward and even succeeded in turning certain opportunities to our advantage to further elevate medtech among key stakeholders.
With the intention to point out the challenges as well as suggest solutions, SAMED leadership attended important meetings, two of them facilitated by AMCHAM, to advocate for policies that are pro-South Africa and pro-sustainable medtech industry.
We were able to state our case to the President Cyril Ramaphosa, the Minister of International Relations and Cooperation Dr Naledi Pandor, and on two different occasions to the Deputy President Paul Mashatile. I am eager to share that these high-ranking officials gave us their full attention. They had keen interest and genuine appreciation for the role of medtech in healthcare, society and economy and invited SAMED to stay engaged.
During these productive meetings, we spoke about pain points such as the impact of the energy crisis on the healthcare value chain including hospitals, suppliers and local manufacture, crime and corruption, transport, logistics and the red-tape-related obstacles to business productivity. These national leaders assured us about government’s commitment to a continued relationship with the US and to safeguarding business sustainability and appraised the SAMED representatives of plans to renew AGOA in light of its expiry in 2025.
Rob Millar
Honorary Member
Appreciation and tributes to colleague and friend
Rob Millar built an illustrious career in our industry and within the health sector holistically. He has served as the SAMED Chair, Treasurer and chair and vice-chair of SAMED’s Code and other committees. Rob’s depth of knowledge on ethics and good governance will be hard to surpass – but it was his straight-as-the-arrow manner and deep humanity that gave him the awareness and aptitude to know wrong from right, what drives them and how to resolve the negatives and encourage the positives. SAMED will miss Rob and his inspirational and generous contributions. Thank you, Rob – all of us wish you much joy in your retirement.
Rob was awarded SAMED honorary membership in 2023, the only one thus far in SAMED’s history.
On behalf of the board, I wish to thank the SAMED secretariat and its small but growing and always exceptionally committed staff for their efforts and support provided to me, our committees and most importantly, the members.
Peter Mehlape
Chairperson
Executive Officer’s Report
During 2023-24, it became clear that SAMED’s position and recognition have been elevated. This past year has opened a number of doors. We received more invitations to attend and represent the industry on many more forums than ever before, showing that we were determined and successful in pursuing the strategic imperative to elevate medtech and elevate SAMED.
This provided energy and impetus to address challenging topics and areas of concern for our members such as outstanding government payments. SAMED also achieved much on matters of compliance and regulatory alliance, regulatory harmonisation and convergence.
Looking ahead we are soon going to experience major regulatory changes, starting with a pilot programme for medical device product registration that SAHPRA will initiate towards the end of 2024. This is a whole new era for our sector and SAMED will make sure that we are involved, that we are guiding SAHPRA, that we are listening to them and that we are sharing the latest information so that our members can plan for the future.
Tanya Vogt
SAMED Executive Officer
To the next level on
localisation
SAMED is supportive of the momentum that is building among policy makers, partners, funders, medtech industry and other stakeholders in taking the localisation of medtech to the next level. We all share in the key learning from the COVID-19 pandemic and the country’s trade deficit underscores the urgent need to meaningfully elevate local medtech in terms of supply chain integrity, policy, resources, empowerment, job creation, skills creation, technology transfer, research and more. I am pleased to report on several positive developments in this area that SAMED has undertaken or been part of during this last year.
SAMED has established a local manufacturers interest group with the objective to identify synergies and activities to support the growth of the medtech manufacturing sector.
The interest group is not limited to local manufacturers and welcomes engagements with all parties keen on exploring this objective, including distributors and multinationals.
The key here will be to work together and to work smart rather than to duplicate efforts or start demarcating territories. In this spirit, we held an introductory meeting and on 10 April 2024, a longer follow-up session with fellow interest-group partners, namely SALDA, MDMSA, Western Cape Device Cluster and the Medical Device Professionals Group. We discussed each entity’s current activities related to local manufacturing and opportunities for joint action. The agreed next step is to regroup with the goal of identifying areas for collaboration.
Closely linked to the localisation mission is the MEDTECH MasterPlan.
SAMED appreciates the dtic and other involved role-players who have given invaluable support to this national initiative that is poised to benefit the healthcare sector, our customers and patients and more broadly, South Africa and the continent.
Realising the vision and objectives of the Master Plan requires institutional coordination, as well as a range of policy, regulatory and programmatic interventions. Before it was finalised, SAMED held a CEO pulse meeting where the plan was presented and thereafter shared with member companies to obtain your opinions and suggested changes.
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SAMED contributed to two exceptionally valuable and well-planned workshops focused on African cross-border medical technology regulatory convergence and good practice. Implementation of best practices will reduce cost, inefficiencies, poor quality and the deployment of unsafe products, services and infrastructure.
Convergence is another area that is reaping the benefits of partnership efforts that envisage greater localisation of medtech, greater ease of trade across the AfCFTA and other positive socioeconomic outcomes.
SAMED played a major role in planning a medical device regulatory workshop which was held under the Medical Device Regulatory Convergence (MDRC) project in November, with joint organisation by SAHPRA and regulators from Australia, Brazil, Singapore and the United States. The programme included capacity building sessions and presentations by subject matter experts including global and local manufacturers.
A score of topics was addressed, such as IMDRF, international standards including ISO 13485, conformity assessments and Good Reliance Practices. I had the honour of moderating and presenting in a session on the South African medical devices and IVDs landscape.
SAMED participated in the US Trade and Development Agency regulatory convergence workshop that covered medical device and medicines regulatory frameworks, reliance models, impact assessments and industry perspectives. We supported the organisers in terms of the programme and moderated a session on the implementation of reliance models in which the participants unpacked the critical role of regulatory convergence and strengthening collaborative efforts to close the gaps between concept and implementation.
I urge members to consider the implications of Project 18C not only for the health sector but all its stakeholders and health system users. The project will further spotlight ethical marketing and business practices and compliance with the Medical Device Code across our sector and magnify what is at stake. We can best respond by standing together and aligning principles, positions and actions on ethics, governance, and accountability.
I’m delighted to highlight that although this year brought multiple developments and important rewards through our efforts to elevate medtech and SAMED among stakeholders, the secretariat ensured this was matched by energetic, considered, and productive internal management.
As part of ongoing work to safeguard and strengthen governance, SAMED’s task team in consultation with experts reviewed and revised the SAMED Constitution, which was adopted at the 2023 AGM and is now in effect. A notable change is the introduction of an elected board nomination and selection process designed to encourage equity, diversity and inclusion in the representation of and participation by SMME member companies.
As you might have gleaned from various regular updates that we share with member companies, including SAMED News, From the Desk of the EO and In the SAMED Chair, the association is being sought after as a thought leader on medtech and more broadly on other topics such as good governance, anti-corruption, ethics, industry self-regulation, diversity and transformation, regulatory convergence and patient access.
To help SAMED leaders who are selected to represent SAMED at various stakeholder platforms and meetings be aligned on message and approach, the coming year we will be developing SOPs for the executive officer, committee chairs and the chairperson and other members of the board.
Shaping regulations
together
SAMED contributed to two exceptionally valuable and well-planned workshops focused on African cross-border medical technology regulatory convergence and good practice. Implementation of best practices will reduce cost, inefficiencies, poor quality and the deployment of unsafe products, services and infrastructure.
Convergence is another area that is reaping the benefits of partnership efforts that envisage greater localisation of medtech, greater ease of trade across the AfCFTA and other positive socioeconomic outcomes.
SAMED played a major role in planning a medical device regulatory workshop which was held under the Medical Device Regulatory Convergence (MDRC) project in November, with joint organisation by SAHPRA and regulators from Australia, Brazil, Singapore and the United States. The programme included capacity building sessions and presentations by subject matter experts including global and local manufacturers.
A score of topics was addressed, such as IMDRF, international standards including ISO 13485, conformity assessments and Good Reliance Practices. I had the honour of moderating and presenting in a session on the South African medical devices and IVDs landscape.
SAMED participated in the US Trade and Development Agency regulatory convergence workshop that covered medical device and medicines regulatory frameworks, reliance models, impact assessments and industry perspectives.
We supported the organisers in terms of the programme and moderated a session on the implementation of reliance models in which the participants unpacked the critical role of regulatory convergence and strengthening collaborative efforts to close the gaps between concept and implementation.I urge members to consider the implications of Project 18C not only for the health sector but all its stakeholders and health system users. The project will further spotlight ethical marketing and business practices and compliance with the Medical Device Code across our sector and magnify what is at stake. We can best respond by standing together and aligning principles, positions and actions on ethics, governance, and accountability.
Elevating our values
and sectoral interests
I’m delighted to highlight that although this year brought multiple developments and important rewards through our efforts to elevate medtech and SAMED among stakeholders, the secretariat ensured this was matched by energetic, considered, and productive internal management.
As part of ongoing work to safeguard and strengthen governance, SAMED’s task team in consultation with experts reviewed and revised the SAMED Constitution, which was adopted at the 2023 AGM and is now in effect.
A notable change is the introduction of an elected board nomination and selection process designed to encourage equity, diversity and inclusion in the representation of and participation by SMME member companies.
As you might have gleaned from various regular updates that we share with member companies, including SAMED News, From the Desk of the EO and In the SAMED Chair, the association is being sought after as a thought leader on medtech and more broadly on other topics such as good governance, anti-corruption, ethics, industry self-regulation, diversity and transformation, regulatory convergence and patient access.
To help SAMED leaders who are selected to represent SAMED at various stakeholder platforms and meetings be aligned on message and approach, the coming year we will be developing SOPs for the executive officer, committee chairs and the chairperson and other members of the board.
SAMED organised 30 member events during the year. Most events strive to equip members with information and practical resources they can use to strengthen and improve their businesses. The total attendance of members and external stakeholders at our events was 1 533 delegates. Strong attendance speaks to the strategic approach SAMED brings to its events so that they provide value to all speakers and participants. Two events that accounted for 250 attendees were the annual conference (144) and a Market Access Forum that was devoted to the public sector debt (106).
Working strategically, SAMED used its own activities – such as the launch of four new platforms – as well as opportunities provided by national developments to elevate our public presence. If you have not done so already, you can catch up on the positive media reports on SAMED in timeslive, African Business Quarterly, newzroom afrika and Business Day.
This year SAMED piloted having a promotional presence at Africa Health with a conference booth and joining other speakers in a session on transforming medtech through youth and women development. That we are on the right track to elevate medtech in South Africa and much further is evidenced by frequent approaches and invitations from foreign trade missions to meet SAMED and to learn about our industry and opportunities it presents. During this year, we had the pleasure to engage with delegations from France, Japan, Korea, Switzerland and Vietnam.
An exciting initiative that we spent more time on during the reporting period is the Rare Diseases Access Initiative which also involves funders, pharmaceutical industry and patient advocacy groups.We have convened a number of meetings to discuss how we can support and possibly co-create policy for patients with rare diseases as their needs are often overlooked both in the public and private sector due to insufficient funding or treatment options.
We have convened a number of meetings to discuss how we can support and possibly co-create policy for patients with rare diseases as their needs are often overlooked both in the public and private sector due to insufficient funding or treatment options.
Our public sector debt initiative is based on the Data with Integrity platform which we began to develop in 2022. In order to help members adopt and become comfortable with the system, we are using it for invoicing, and we now channel the collection of any data we require from members through the platform. The outstanding payments data is being generated by facility, province and age, allowing us to compare amounts owing and use that data to meaningfully engage with provincial departments of health, provincial treasury, the national department of health and as needed, the presidency.
The Women Empowerment Index is another section added to the data platform. I wish to acknowledge the chair of the Diversity in Medtech Committee, Scott de Oliviera, for his leadership and for bringing his passion and energy to fuel progress in transformation. Under his leadership, the committee was renamed from ‘Transformation’ to Diversity in Medtech, to symbolise SAMED’s integrated approach to making and realising real opportunities to pioneer sectoral economic empowerment of women, youth and people with disabilities.
Under the guidance from the Code Committee, SAMED provided 12 non-binding advisory opinions to members and external stakeholders regarding the Code. Opinions are circulated to company compliance officers and these resources are available for you to access in the SAMED library.
SAMED secretariat growth and capacity building
To ensure that the association’s strategies are successful, that members’ needs are adequately met, to efficiently manage the volume of work, and achieve greater reach and impact, the SAMED office has also seen transition and capacity building. During the year, the secretariat welcomed four new staff members.
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Ntokozo Dlamini is the projects coordinator responsible for Data with Integrity, the Medical Device Code certification and outstanding public sector payments.
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Linda Crystal joined SAMED in October as the Executive Secretary and Membership Relations.
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In March, Nomthi Mnisi was appointed as the new Marketing, Communications and Events Manager.
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In April, SAMED itself said YES and the new intern, Dikapo Magolego, is already showing passion to work hard and learn fast.
We wish the newcomers much professional and personal success and fulfilment during their tenure at SAMED and look forward to harnessing your interest and energy to jointly elevate medtech.
A special thank you to Amanda Wilde who stepped in to assist with secretariat support and administration, particularly in getting membership invoices and VAT debit notes paid.
In the atmosphere of growing, building and strengthening, Ntokozo Dlamini and Emily Mehtlape have attended different practical skills-building courses which they are busy putting to great use.
Sadly, towards the end of the reporting period, we said goodbye to Caroline Scott who handed over the baton for marketing, communication and events to Nomthi Mnisi. We appreciate the many innovations and improvements Caroline realised within her portfolio during the four-year tenure at SAMED and wish her many successes and adventures along the professional journey.
In closing, I would like to express my heartfelt appreciation to the Chairperson, Vice-chair, the Treasurer, members of the Board and its committees, SAMED staff and members of SAMED for helping to advance patient care through medtech.
Tanya Vogt
Executive Officer
Elevating Diversity in Medtech
This year SAMED pulled out all the stops to elevate diversity and inclusivity not only internally – meaning within the secretariat, the board and among our members – but also externally.
New seminal initiatives catalysing change
SAMED Women Empowerment Index was unveiled to members, partners, influential industry voices, government and captains of industry during the SAMED Catalysts of Change forum on 11 April 2024. The in-person event launched two ground-breaking initiatives: the SAMED Women Empowerment Index (WEI) and the SAMED x YES Youth Alumni Portal.
The WEI is a benchmarking tool developed in collaboration with Deloitte and SAMED members to monitor and encourage progress made towards greater economic inclusion and empowerment of women in the medtech industry.
The WEI will establish baseline scores and track these metrics that matter over time: women's employment rates and remuneration levels, female representation in leadership positions, women's ownership in medtech companies and opportunities for women’s development.
Industry executives and influencers among whom were Adv Mikateko Joyce Maluleke, Director General, Department of Women, Youth and People with Disabilities, and Futhi Mtoba, Co-Chairperson, Women Economic Assembly (WECONA), Dr Rolene Wagner, HOD, Eastern Cape DOH, Dr Viola Morolo, Specialist Urologist, African Synergy Health (ASH) and powerful panels underscored the urgency of addressing gender disparities.
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166
Youth profiles
The SAMED x YES Youth Alumni Portal is an online platform that puts medtech companies in touch with talented young professionals who already have valuable industry experience.
This resource hosts the profiles of 166 talented youth who have already gained experience in our industry. We encourage members to give it a go and see how you can skip recruitment fees and fill your vacant positions with young people who have the passion to succeed and understand our field.
“Simply put, we have to hire more women and open equal access for our female peers to educational and professional opportunities within our companies and workplaces.”
Scott de Oliviera, Chairperson, Diversity in Medtech committee
SAMED’s other main transformational interventions include a commitment to WECONA since it was inaugurated in 2022, the creation of more than 2 897 youth jobs (64% female youth employees) by 42 SAMED members through the partnership with YES Youth Employment Service and participation in the Skills Village capacity building hubs that lead to income-generating activity for youth, women and persons with disabilities. Considering the unemployment crisis in South Africa, these positive outcomes and their impact are worth celebrating.
Data With Integrity
Data With Integrity (DWI) is SAMED’s custom-made member company information collection and storage system which went live in 2022, with ongoing system checks, management, maintenance and development to improve user experience and ensure ease of use.
Ntokozo Dlamini
SAMED Projects Coordinator
As part of member education and change management, SAMED provided numerous briefs, practical mailers, training sessions and reminders to support members’ participation, engagement and registration on the portal. The slow-to-start first phase provided invaluable learnings that were used to inform when and how we send data collection requests for data and the development of system pathways.
We heard and acted on the feedback from member companies that they would find participation more manageable if the phases and methods for data collection were more flexible. The portal was updated for easier navigation and to enable the submission of topic-specific smaller batches of data, for example company details, company invoicing, employment, finance and so on, at different times and by different registered users. Since the platform went live, two new layers of data collection have been integrated, namely the public sector debt and the Women Empowerment Index.
This approach is working well for concentrated campaigns and quick polls which deliver real data with integrity to inform vital submissions, such as those on the SAHPRA fees payable and SAHPRA’s draft B-BBEE policy.
We are indeed witnessing the power of data at play as we use our “numerical treasure” to improve SAMED representation and submissions, understand and manage our own businesses more effectively and further elevate medtech among stakeholders.
Table: Latest DWI participation statisticsCoordinator
The Code: upping the ante on formalised self-regulation
SAMED’s Code Committee has had an extremely busy and productive year during which it tackled several sizable endeavours. SAMED’s Code Committee completed the eight version of the Medical Device Code of Ethical Marketing and Business Practice. This was a lengthy labour of love that now suitably displays SAMED’s respect and dedication to the strongest ethics and business and marketing practices in all transactions between medtech suppliers and HCPs and other customers. The committee members individually and as a group reviewed our Code letter-by-letter and page-by-page multiple times. They compared the Code against international benchmarks like the codes enforced by Mecomed in the Middle East, MedTech Europe and Advamed in the United States.
Old sections were updated, and new sections added. The 90+ questions-answers were examined and strengthened by including new responses to the most frequent topics of enquiry from members and other SAMED stakeholders. Nine documents and templates will be downloadable from the digital Code. The launch of the attractive and user-friendly new-and-improved Code is among SAMED’s top priorities for the coming year.
Additionally, the script and the complaint form used by the third-party independently managed Medical Device Hotline were assessed with some of the elements and messages strengthened to support efficient collection of information and evidence to enable successful investigations and rulings on reported cases.
Frequent questions on conference vetting and criteria that influence whether an event falls under the jurisdiction of the European CVS prompted SAMED to host a spirited Medical Device Forum to clarify uncertainties and misunderstandings. Following this event, we have provided a simplified one-page resource to member companies’ compliance officers, marketing, public affairs and other departments, professional societies, conference organisers, academic institutions and other entities involved in educational events.
The dynamic Project 18C has gained encouraging impetus, with the signing of a memorandum of understanding by SAMED and the Marketing Code Authority (MCA) in January 2024. We followed that up with two constructive engagements with the National Department of Health. The focus has now shifted to ensuring the industry and government collaborate on a rigorous policy formulation and adoption process – which will greatly benefit, in time, from member support and involvement.
Dr Vitor Ferrão
Chair: SAMED Code Committee
The scope of Project 18C covers advertising and promotion of medical devices, IVDs and medicines – collectively health products. It aims to successfully motivate for the publication of regulations that recognise and support the enforcement of industry self-regulation codes. Such regulations are set to level the playing field by making it compulsory for all licenced health products suppliers to commit to a recognised industry code.
The MOU between SAMED and the Marketing Code Authority covers other matters including: (i) funding; (ii) member associations’ roles such as the development of policy, regulations and codes; (iii) enforcing and monitoring these Codes; and (iv) collaborations to raise awareness and educate stakeholders on ethical marketing and business practices health products.
Building a robust and fit-for-purpose regulatory system
The year 2023/24 presented numerous occasions for SAMED’s continued engagements on legislation and policy developments related to the medtech sector and the healthcare environment more broadly.
SAMED supports the overarching objectives of sections 18A and 18B of the Medicines and Related Substances Act and the intent of related draft regulations which is to prevent perverse activities and ensuring affordable medical devices and IVDs. However, the potential prohibition of certain practices that are applicable and beneficial in the medtech sector but not the pharmaceutical industry could cause downstream impact that needs to be properly understood so that the unfavourable consequences can be avoided.
In response to SAMED’s previous request, the Minister of Health had granted medical devices and IVDs a three-year exclusion from these regulations. As the exclusion ends on 10 December 2024, SAMED engaged with SAHPRA and the Pricing Committee during this year regarding timelines for the finalisation of relevant regulations and to explore options for a further exemption. It is pleasing to report that in March 2024, SAHPRA responded positively to SAMED’s reminder of the upcoming expiry of the exclusion, indicating that the Medical Device Unit will submit a request for the extension of the exemption and that SAMED can follow-up with the unit in September for any updates.
In consultation with members, the various SAMED Committees with assistance from legal counsel, made comprehensive submissions on eight policy drafts, namely: the draft Medical Device Regulations, the Public Procurement and NHI bills, SAHPRA’s fees payable and its B-BBEE policy, the updated Employment Equity Act Sector Targets, Western Cape Health Department’s proposed pricing labels and Private Nurse Practitioners Regulations.
A clear priority for the upcoming year will be the draft Medical Device Product Registration road map which SAHPRA officially communicated in April 2024. The roadmap incorporates a feasibility pilot for product registration. As we travel this journey together, we truly appreciate the regulator’s ongoing willingness to engage with SAMED – demonstrated by SAHPRA’s recent removal of medical device and IVD product registration fees from the revised Fees regulations until after the draft medical device regulations had been finalised and the pilot conducted.
Regarding National Health Insurance, SAMED participated in the Business Unity South Africa (BUSA) NHI discussions and strategies to further elevate medtech considerations within the broader business community and strengthen partnerships to achieve mutual goals.
Avanthi Govender Bester
Chair: SAMED NHI Committee
Closely connected to this is the future procurement model under NHI and we used multiple platforms to communicate SAMED’s view on the risks of the proposed centralised “all eggs in one basket” approach and to argue for the establishment of an independent health technology assessment (HTA) agency. However, we still face another hurdle along this path which is the absence of empowering legislation for the formal establishment of an HTA agency without which any recommendations will lack legitimacy and therefore enforceability.
Medtech reimbursement
During the year, SAMED leadership continued with intensive work to motivate for appropriate reimbursement of medtech technology by customers in both the public and the private sectors.
Donata Kubheka
Chair: SAMED Market Access committee
Unfortunately the old problem of massive debt by public sector customers to our members persists. Some 15 years ago, SAMED resorted to raising the matter through the media while the previous year, we mobilised action and short-term relief by involving the Presidency.
As the consolidated member company invoices that are due over 30 days surpassed the R1 billion mark in February 2024, once again we formulated a plan in case we have to escalate matters beyond the regular monthly communications and provision of detailed analyses of outstanding amounts to the national and provincial health departments. Please note that in addition to emailing the health department key officials, SAMED has held meetings with some of them, namely at national level as well as with Gauteng, Limpopo and the Western Cape teams who have all expressed a commitment to look into the matter.
This table with the outstanding payment summary from February 2024 illustrates the severity of the problem.
What is additionally concerning is that these figures are likely to be higher because not all the member companies that have public sector invoices outstanding provide information on the debt owed to them. We urge all affected members to participate and thereby enable SAMED to address the issue in its entirety and to put the matter to government more convincingly.
South Africa has the necessary government instruments in place for this issue to become a concern of the past. They just have to be properly implemented. So if your business is being negatively impacted, if you’re struggling with cashflow and stressing at month-end how to pay salaries or suppliers, by participating in providing your data, you will be doing good for your own organisation as well as helping SAMED act on your behalf by ensuring we have more complete and more credible information to put forward a convincing argument to our government counterparts.
In the meantime, we have significantly improved the collection and quality of the outstanding payments data by integrating the submission process with the Data with Integrity portal. Please use the system and provide your data timeously to reap its benefits for your own organisation and strengthen SAMED’s case with the relevant authorities. Please reach out to projects@samed.org.za for help with registering.
On the private sector front, SAMED held crucial conversations with Discovery and the Council for Medical Schemes to educate them about our sector, its essential role in health service provision and the urgent need to recognise the reimbursement pressures and cost of doing business. All of these have impacted on the industry since the tail end of the COVID-19 pandemic. The multiple factors that have hit the medtech industry include the state of South Africa’s economy, exchange rate fluctuations, the increased costs of logistics and fuel and power disruptions. These all erode the already slim margins. The message we shared with Discovery, the Council and other relevant role-players is that these factors must be considered when engaging member companies on annual price negotiations.
SAMED Board Members
18 May 2023 – 27 May 2024
SAMED Committees
SAMED membership
ORDINARY MEMBERS
Abbott Rapid Diagnostics (Pty) Ltd
Abex Pharmaceutical (Pty) Ltd
Absolute Orthopedics (Pty) Ltd
Acino Forensics (Pty) Ltd
Advanced Orthopaedic Solutions (Pty) Ltd
Africoncur Medical (Pty) Ltd
AHG Health Solutions (Pty) Ltd
Akacia Medical (Pty) Ltd
Alcon Laboratories (Pty) Ltd
Allenco Medical and Dental Supplies
Alltech Healthcare (Pty) Ltd
Ample Resources (Pty) Ltd
Anstem Medical (Pty) Ltd
Ariste Health (Pty) Ltd
Arjohuntleigh South Africa (Pty) Ltd
Arterial Medical (Pty) Ltd
Ashanti Medical cc
B.Braun Medical (Pty) Ltd
Bausch + Lomb
Bcc Pharmaceuticals (Pty) Ltd
Becton Dickinson (Pty) Ltd
Beier Drawtex Healthcare (Pty) Ltd
BioTech Africa (Pty) Ltd
Bloemed Medical Supplies and Services cc
BMG Orthopaedic Solutions (Pty) Ltd
Bone SA
Boston Scientific South Africa (Pty) Ltd
BSN Medical (Pty) Ltd
Carl Zeiss (Pty) Ltd
Casmed Logistics (Pty) Ltd
Centre for Tissue Engineering
Chairman Industries (Pty) Ltd
Cherrymed Enterprises (Pty) Ltd
Coloplast A/S
Continuous Oxygen Suppliers (Pty) Ltd Trading as VitalAire
Convatec South Africa
Corin SA (Pty) Ltd
Cossni Medical (Pty) Ltd
Creatori Health (Pty) Ltd
Dahlhausen (Pty) Ltd
Demant South Africa (Pty) Ltd (previously Oticon)
Dimela Health (Pty) Ltd
Dr Temp (Pty) Ltd
Dräger South Africa (Pty) Ltd
Duzane-Africa Medical (previously Future Med Co)
Edwards Life Sciences South Africa (Pty) Ltd
Elegant Line Trading 64 cc
Elekta (Pty) Ltd
Endosurgical (Pty) Ltd
Ethitech (Pty) Ltd
Fluorovizion Holdings
Fresenius Medical Care South Africa (Pty) Ltd
Gabler Medical (Pty) Ltd
GE Medical Systems South Africa (Pty) Ltd
Grobir Medical Suppliers (Pty) Ltd
Guerbet South Africa (Pty) Ltd
H.A.S.S Southern Africa (Pty) Ltd
Hartmann Vitamed (Pty) Ltd
HemoCue South Africa (Pty) Ltd
Hi Care Surgicial (Pty) Ltd
Imperial Market Access Healthcare SA (Pty) Ltd
Implantcast South Africa (Pty) Ltd
Imvula Health care Logistics (Pty) Ltd
JaLo Enterprise (Pty) Ltd
Johnson & Johnson Medical (Pty) Ltd
K2 Medical (Pty) Ltd
Karl Storz Endoscopy SA (Pty) Ltd
Kiara MedTech (Pty) Ltd
Langamedics (Pty) LtdLatroglo
Medics (Pty) Ltd
LDK Intertrade (Pty) Ltd
Lechoba Medical Technologies (Pty) Ltd
Ligamed (Pty) LtdLorumir D (Pty) Ltd
Lukatit Investments 14 (Pty) Ltd ta Unitron
SAMaars Medical (Pty) Ltd
Maisha Med (Pty) Ltd
Maquet Southern Africa (Pty) Ltd
Marcus Medical (Pty) Ltd
MED-EL Distribution (Pty) Ltd
Med-EL Impant Systems South Africa (Pty) Ltd
Medhealth Supplies (Pty) Ltd
Medical International Orthopaedic cc
Medical Plant Africa (Pty) Ltd
Medtronic Africa
Meducat Medical (Pty) Ltd
Melemo Medical
Mental Link International (Pty) Ltd
Merck Life Science
Meril SA (Pty) Ltd
Merit Medical South Africa (Pty) Ltd
Mezotrix (Pty) Ltd
Modiro Medical (Pty) Ltd
Morgan Joshua Innovation
Mossmed (Pty) Ltd
MyOrtho Solutions (Pty) Ltd
National Bioproducts
Institue NPC
Neurophysics (Pty) Ltd
NGL Logistics Solutions
Nipro Medical South Africa (Pty) Ltd
NuAngle Solutions (Pty) Ltd
O&M Halyard South Africa
Obsidian Health (Pty) Ltd
OMS Medical (Pty) Ltd
Optimum Orthopaedics (Pty) Ltd
Ortho-Design (Pty) Ltd
Orthomedics
Ortho-Xact (Pty) Ltd
Osteologix SA (Pty) Ltd
Paragon 28 Medical Devices Trading Limited
Patient Medical Care T/A Zebra
MedicalPerryhill International Trading (Pty) Ltd
Philips South Africa (Pty) Ltd
Phoenix Neomed
Pinnacle Innovations (Pty) Ltd
Pointer Medical (Pty) Ltd
Population Services International SA (Pty) Ltd
PrimeSafe (Pty) Ltd T/A SteriTech
PrionGuard
Priontex
SAPrism Inter Africa cc
Procter & Gamble South African Trading
Professional Orthopaedics (Pty) Ltd
Progress Medical Supplies
Progressus Digital
Q-Surgical
Responsive Orthopaedics (Pty) Ltd
Roche Diagnostics (Pty) Ltd
SA Biomedical Holdings (Pty) Ltd
Safarmex (Pty) Ltd
Safmed (Pty) Ltd
Sea4 Medical Logistics (Pty) Ltd
Selective Surgical (Pty) Ltd
Siemens Healthcare (Pty) Ltd
Smith & Nephew (Pty) Ltd
Soflens
Southern Ear Nose and Throat (Pty) Ltd
Southern Implants (Pty) ltd
Staar Surgical (Pty) Ltd
Stiegelmeyer Africa (Pty) Ltd
Stryker South Africa (Pty) Ltd
Supra Healthcare (Pty) Ltd
Sure Medical (Pty) Ltd
Surgical and Ophthalmic Supplies (Pty) Ltd
Surgical Innovations (Pty) Ltd
SXS Surgical Solutions (Pty) Ltd
Synthecon Sutures Manufacturing SA cc
Systagenix T/A Solventum
Tara Healthcare
Teekay Link Medical Solution
Teleflex Medical (Pty) Ltd
The Scientific Group
Thogwa Medicals and Pharmaceuticals (Pty) Ltd
Umsebe Healthcare
Vertec Scientific SA (Pty) Ltd
Vertice Healthcare (Pty) Ltd
Viking BCT (Pty) Ltd
Viking Cardiovascular (Pty) Ltd
Werkomed (Pty) Ltd
WS Audiology South Africa (Pty) Ltd
Zimmer Biomed South Africa (Pty) Ltd
ASSOCIATE MEMBERS
AfriPharm SA (Pty) Ltd
BRANDTECH Health Technology Consulting
CEASA (The Clinical Engineering in South Africa)
CSIR
DI Medicine Regulatory Consultants
Diverse Conversations
Dr Vitor MLdeA Ferrao Executive Consultant
DSV Solutions (Pty) Ltd
Enterprise Ireland
Institute of Bio Research Auditing and Training in Southern Africa (IBRATSA)
IQuad Integrated Management Systems (Pty) Ltd
JC Auditors
JPJ Medical
KOTRA
Mark Banfield & Associates
Masoom Training Solutions
Mawele Investments cc
MC Pharma Consulting (Pty) Ltd
MEDInc SA
Regulatory For Africa
Exciting times in the coming year
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SAMED’s 40th anniversary
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Implementation of the MEDTECH Masterplan and medical device and IVD product registration
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Continuing to strengthen our stakeholder relationships
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Finding lasting solutions to public health debt
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Growing our Data With Integrity
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Reporting on the Women Empowerment Index
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SA hosting G20 Summit and taking over its Presidency
