Thank you, SAMED members, for playing active roles in the numerous and diverse initiatives which SAMED pursued this year in order to achieve our objectives and elevate medtech.



Safeguarding, promoting and representing members’ common interests

  • Developing a health product regulatory qualification course framework with CHIETA
  • Advocated with the President, Minister, Deputy Minister and DG of Health and PDOHs on outstanding public sector debt
  • Strengthened SAMED’s visibility and positioning through the establishment of SAMED’s Marketing Committee and growing SAMED’s LinkedIn page
  • Engaging with international trade associations – the GMTA, Medtech Europe, Advamed, Mecomed and GHWP – to share and learn best practice, advance regulatory harmonisation and stay on top of international trends
  • Addressing regulatory hurdles at the AfriSummit MedDevReg sessions
  • Taking initial steps to establish a localisation working group to drive policy change for an enabling environment
  • Launched a data collection mechanism that integrates medtech outstanding public sector debt, regulatory landscape, employment statistics, manufacture capabilities and import/export data
  • Leveraged our chair’s, AMCHAM’s and BUSA’s contacts to meet with the President, Deputy President and Minister of International Relations and raise business and trade-related concerns
  • Secured Deputy Minister and DDG of Health to speak and network at member events
  • Hosted Captains of Industry forums with SAHPRA CEO Dr Boitumelo Semete-Makokotlela and Vic van Vuuren on the dtic Health Products Masterplan
  • Advised in the process of NDOH’s appointment of Fundile Gebremedhin as Director: Medical Devices & HealthTech Procurement Management and contributed to orientating and building his skills
  • Project Pay On Time launched by KZN DOH to speed up supplier payments

Driving compliance with ethical principles and practices

  • Investigated two Code hotline complaints with a third on-going
  • Liaising with NDOH, Treasury and SAHPRA on Project 18C
  • Engaging with professional societies and KOLs such as Prof Mmampapatla Thomas Ramokgopa to raise awareness of the Code and its stipulations eg industry approaches to registrars, company-arranged and third-party events and disbursement of educational grants
  • Facilitated discussions on CVS requirements and their applicability for South Africa
  • Planning a 2024 industry and stakeholders workshop on the revised Code and CVS requirements
  • Provided 14 free-of-charge non-legally binding advisory opinions to help member companies be compliant and build compliance skills
  • Revised the Medical Code of Ethical Marketing and Business Practice to strengthen self-regulation, continue to safeguard clinical judgement, industry reputation and patient interest, align with international and local best practices and shared jurisdictions, update the format for easier navigation and build members’ compliance skills
  • Reviewed SAMED Constitution to strengthen governance and operational requirements

Promoting access to medtech for better patient outcomes

  • Engaging with NDOH Medical Devices & Healthtech Procurement Management
  • Capacity building including hosting of five Market Access Forums
  • Addressing medtech sector concerns including trade barriers, reimbursement matters with Discovery
  • Produced and published SAMED’s position paper on HTA Agency
  • Co-created an improved provincial consignment stock process with KZN DOH
  • Submitted comment on the Public Procurement Bill
  • Participated in the Discovery Pin review process to ensure best practice and consideration of medtech requirements

Shaping best practices in standards, policies and regulatory requirements

  • Advocating on access, regulatory hurdles and matters of medtech sustainability, including the MDRC and the ITG, with SAMED as a lead of the Medical Device Working Group
  • Participating in two BUSA Committees, Economic & Trade Policy (energy, tax, transport, trade, logistics, ESG) and Social Policy (education, training, health including NHI and transformation)
  • Submitted comments on nursing regulations and NHI
  • Hosted an NHI Forum on legal implications, BUSA’s position and SAMED submission
  • Appointed an NHI service provider to assist us in monitoring progress on the Bill and advocating for medtech throughout policy formation
  • Made a submission on medical device regulations

Growth for sustainability

  • Engaging with experts, the dtic, NDOH and SAMED members to identify medtech-related challenges and opportunities in the Health Products Master Plan and providing inputs on the plan
  • Promoting local content and South Africa as an investment and partnership destination among embassies, trade commissions and international trade forums
  • Serving on CSIR local manufacture panel, steerco of MeDDIC and NAB [NAPPI® Advisory Board]
  • Secured discounted rates for ISO13485 audits and training as part of member certification
  • Participated in Africa Health, with the SAMED Chair and Executive Officer attending, presenting and facilitating sessions related to SAMED’s strategic objectives
  • Submitted comment on the medical device fees

Economic and social transformation for sustainable change

  • Preparing for the launch of the Women Empowerment Index
  • Hosted the second and third Women in Medtech forum with conversations on gender bias, discrimination and roles of men and women in creating sustainable change
  • Created 2 700 youth jobs and R153m in salaries to date by 41 YES-registered SAMED members – a major increase since November 2022 (1 900 jobs, R108m in salaries by 33 SAMED members) and launched the SAMED-YES alumni programme
  • Supported the eventing/gifting SMME, Innovative Entrepreneurs, including upskilling the team for better event management and providing a platform for showcasing offerings
  • Submitted comment on SAHPRA BBBEE policy