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Closing date for registration: 8 October 2021Members and non-members welcome
CPD Accredited with 3 Ethics and 9 Clinical CPD Points
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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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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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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
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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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By the end of March 2022, SAMED members need to meet certain obligations with regards to the Medical Device Code of Ethical Marketing and Business Practice (the Code). Compliance officers will be required to train customer-facing employees on the Code and ensure that they pass the online certification test before signing the annual declaration.
Member Only
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Earn 2 Ethics CPD points
In this session learn more about:
- The requirements and processes for getting CPD accreditation on articles, events and training from MPC Director, Mieder Erasmus
- Managing requests from HCPs to participate in clinical activities that fall outside of the scope of company representatives, including potential risk and risk mitigation from Vitor Ferrão, Orthopaedic Supplier Committee Vice-chair
- Developments with SAMED's Section 18A & 18B exemption request on behalf of industry
Special Guest: Mr Andries Sekgetho, Business Executive at the Auditor General’s Office will provide an overview of their special reports on PPE procurement in the Health sector
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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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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2021/2022: Feedback and forecast Join us as we look back at 2021, our activities and achievements, and the SAMED 2022 vision for a sustainable, ethical and transformed medical technology industry. Mandatory Vaccines: To implement or not? Many health sector organisations have implemented mandatory vaccine policies. Find out why, how, the ethical and legal considerations and what medtech companies should consider before implementing policies of their own.
Members-only event
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SAMED has made some amendments to the Medical Device Code of Ethical Marketing and Business Practice. These changes are aimed at strengthening the Code and providing guidance to our members. Updates include changes to definitions, virtual events and the whistle-blowing hotline processes.
Members-only event
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SAMED Market Access Forum
In this forum, we take a look at the importance and use of data within medtech market access particularly in reimbursement and procure.
Members-only event
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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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The pandemic, new technologies and POPIA; the market landscape has changed and altered the way in which businesses operate. Digital communications and POPIA have altered the medtech market landscape.
Join us as we unpack digital sales and marketing and how to bridge the gap with Warren Hickenbotham from Blankpage Media and answer your questions on implementing and adhering to the protection of personal information Act with Pat Matseke from Elsabe Klinck and Associates.
Members-only event
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Dr Alicia McMaster, Associate Director at PWC Healthcare Consulting will delve into reinventing the future as the pandemic edits the DNA of the health system.
Join legal experts as we consider the obligations of mandatory vaccine policies framed within the context of the medtech sector.
Members-only event
