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Calling all medtech executives - be a part of our influential network of business leaders and level up your competitive edge with a BBBEE boost. Join us for our first SAMED CEO Forum as we set the tone and objectives for 2022 and unpack ways to improve sustainability, support industry growth and unlock our sector's transformation potential. You will also hear about the benefits of the Youth Employment Services (YES) programme and how the CSIR have benefited from participation.
Members-only event
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Join us for this workshop with industry-leading experts to learn more on how you can use real-world evidence to better demonstrate the value of your medical devices and in-vitro diagnostics.
Members-only event
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The Council for Medical Scheme's reports can be a valuable tool for engaging medical providers and funders on medtech Market Access matters. In this forum, Elsabe Klinck will share how to lift important information from the reports and use it to substantiate discussions with providers and funders.
Members-only event
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Join us for an overview and interactive discussion on SAMED's submission on the draft Medical Device Regulations. Provide your inputs into the SAMED submission and gain insights for your own submission ahead of the July comment deadline.
Members-only event
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Join us for a review of the medtech regulations in Africa. Learn the latest developments in these evolving regulatory frameworks and gain insights into the requirements to trade medical technologies into Africa. Countries to be covered include:
- Kenya
- Nigeria
- Ghana
- Botswana
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While an extension has been issued on the ISO13485 requirements for licencing, the 3 year period should be used constructively to ensure compliance by the deadline. Understanding the requirements of ISO 13485 is often seen as daunting and many don't know where to start. At our next Regulatory Forum, Shiroma Bennimahadeo from Lloyd's Register will assist in understanding ISO13485.
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The South African Health Products Regulatory Authority (SAHPRA) has published the amended Draft Medical Device Regulation, Join us as we unpack the challenges, concerns and comments. Come give your views and comments on the impact of these amendments on the medtech sector. Non-members welcome.
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In this next forum, we take a look at the Medical Device and In Vitro Diagnostic Regulations in Africa and Europe and how this affects the provision of medical technologies in these areas.
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CSIR Medtech Regulatory support services and programmes with CSIR Team, led by Jeremy Wallis
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African Medical Device Regulations - an update with Lizel Dreyer-Fouche, RA Manager: Africa & Middle East, Abbott Molecular
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Overview of the European MDR and IVDR with Andre ten Napel, Regulatory Consultant, TNMC Medical Devices
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While South Africa faces its own medical device regulatory changes, we cannot lose sight of the changes happening abroad. This forum will look at the regulatory developments from across Africa as well as key considerations of the Post-Brexit medical device regulatory landscape for those trading with the UK. Non-members welcome.
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The National Regulator for Compulsory Specifications (NRCS) has certain oversight functions within the medical technology space. The NRCS has requirements on cables, batteries and plugs on medical devices and equipment and, as highlighted by the pandemic, requirements on masks and disinfectants.
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In this next forum, we take a look at MedTech Europe's submission on the South African draft Medical Device Regulations and the accreditation requirements for ISO13485.
- MedTech Europe submission on the SA draft Medical Device Regulations – Diana Kanecka, Senior Manager International Affairs, Medtech Europe
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Accreditation requirements for the standard ISO13485 - Mookho Morienyane, Assessment Specialist, SANAS
