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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
