BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//SAMED - ECPv6.16.3//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:SAMED
X-ORIGINAL-URL:https://samed.org.za
X-WR-CALDESC:Events for SAMED
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:Africa/Johannesburg
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0200
TZNAME:SAST
DTSTART:20240101T000000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20260721T100000
DTEND;TZID=Africa/Johannesburg:20260721T121500
DTSTAMP:20260727T183503
CREATED:20260714T074158Z
LAST-MODIFIED:20260714T082346Z
UID:16909-1784628000-1784636100@samed.org.za
SUMMARY:Regulatory Forum
DESCRIPTION:South Africa’s medical device regulatory landscape is changing rapidly. \nStay ahead by hearing directly from SAHPRA on evolving regulatory priorities\, licensing and registration pathways\, compliance expectations\, and plans to improve regulatory efficiency. Gain practical insights\, ask your pressing questions during the live Q&A with the SAMED Regulatory Committee\, and ensure your organisation is prepared for the regulatory developments shaping the future of the medical technology and IVD sector. \nProgramme \n10:00 – 11:30 | SAHPRA’s Regulatory Roadmap for Medical Devices and IVDs \n\nGaopalelwe Kelatwang\, Manager: Medical Devices and IVDs (Licensing\, Vigilance and Compliance)\, SAHPRA\nLydia Motlogelwa\, Medical Device Registration Manager\, SAHPRA\n\n11:30 – 12:15 | Q&A with the SAMED Regulatory Committee \nWe encourage attendees to raise their most pressing regulatory questions. This interactive discussion is intended to collectively explore practical solutions to the challenges facing the medical devices and IVD sector. \nTo help us prepare\, please submit your questions in advance to Nomthi Mnisi at communication@samed.org.za \nWho Should Attend \n\nRegulatory Affairs Professionals\nQuality Assurance and Quality Management Teams\nCompliance Managers\nExecutive and General Managers\nMedical Device and IVD Manufacturers\nImporters and Distributors\nLegal and Risk Professionals\nMarket Access and Government Affairs Specialists\nClinical Affairs Professionals\nAnyone responsible for regulatory compliance\, licensing\, registration\, or post-market activities within the medical technology sector.\n\nThis event is free for SALDA\, MDMSA\, and the Western Cape Medical Devices Cluster members only. \nTo register: Click Here
URL:https://samed.org.za/event/regulatory-forum-4/
LOCATION:Virtual
CATEGORIES:Regulatory
ATTACH;FMTTYPE=image/png:https://samed.org.za/wp-content/uploads/2026/07/Regulatory-Forum-21072026-1-scaled-e1784014873284.png
ORGANIZER;CN="SAMED":MAILTO:communication@samed.org.za
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20260324T100000
DTEND;TZID=Africa/Johannesburg:20260324T120000
DTSTAMP:20260727T183503
CREATED:20260302T113259Z
LAST-MODIFIED:20260312T094053Z
UID:16487-1774346400-1774353600@samed.org.za
SUMMARY:MedTech Regulatory Forum
DESCRIPTION:This forum is a key platform for dialogue between industry stakeholders and National Regulatory Authorities (NRAs). With growing interest and activity in markets beyond South Africa\, understanding the regulatory environment is critical for informed decision-making and compliance. \nSpeakers: \n\nMrs. Dorcas Glikpo – Principal Regulatory Officer\, Head – Low Risk Medical Devices Unit\, Ghana FDA\nMrs. Madeleine Pearce – SAMED Board Member & Regulatory Committee Chair | Director of Regulatory Affairs\, Philips Healthcare Middle East\, Turkey and Africa\n\nWho Should Attend: \n\nRegulatory Affairs professionals\nQuality Assurance teams\nBusiness leaders exploring regional market expansion\n\nCost to Attend: \n\nSAMED Members: Free\nNon-Members (MedTech companies and service providers to the MedTech industry only):  R500.00 per person (Excl VAT). Contact Alwi Spearpoint on alwi@samed.org.za to request an invoice prior to registering.\n\nTerms & Conditions: \n\nSAMED reserves the right to approve or prohibit registration by non-members.\nNon-member attendance will only be permitted if fee paid in advance of the event.\n\nRegistration:\nClick here to register
URL:https://samed.org.za/event/medtech-regulatory-forum/
LOCATION:Virtual
CATEGORIES:Regulatory
ATTACH;FMTTYPE=image/jpeg:https://samed.org.za/wp-content/uploads/2026/01/Reg-Banner-v21Jan26-scaled.jpg
ORGANIZER;CN="SAMED":MAILTO:communication@samed.org.za
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20251118T100000
DTEND;TZID=Africa/Johannesburg:20251118T120000
DTSTAMP:20260727T183503
CREATED:20250624T084132Z
LAST-MODIFIED:20251104T120222Z
UID:15469-1763460000-1763467200@samed.org.za
SUMMARY:Regulatory Forum: AI and Medtech - Navigating Change\, Trends\, and Readiness in Regulation.
DESCRIPTION:We are pleased to invite you to the upcoming SAMED Regulatory Forum\, where we will focus on AI and Medtech – Navigating Change\, Trends\, and Readiness in Regulation. \nArtificial intelligence is rapidly reshaping how regulatory\, quality\, and compliance teams in the medtech sector operate. This session\, facilitated by Vicore Health\, a tech-enabled pharmaceutical and regulatory consultancy actively leveraging AI within its own workflows\, will explore how these advances are influencing both organizational structures and individual roles in regulatory affairs. \nKey Themes \n\nIndustry and Regulatory Trends: How global frameworks (EU AI Act\, FDA pilots) and SAHPRA’s digital transformation are redefining medtech regulation.\nOrganizational Impact: How AI can streamline submissions\, strengthen vigilance and audit readiness\, and drive smarter decision-making while managing governance and data integrity.\nPersonal Impact: Adapting to new ways of working\, overcoming “AI anxiety” and building practical confidence to lead responsibly through technological change.\n\nWho Should Attend \nWhether you are a regulatory professional\, quality manager or compliance officer\, this session will help you understand where AI adds measurable value\, what risks to manage and how to start building AI-ready teams and systems for the next era of medtech regulation. \nCost to Attend \n\nSAMED Ordinary & Associate Members: Free of Charge.\nNon-SAMED Members: Please contact alwi@samed.org.za for the cost to attend the event.\n\nRegistration \n\nClick here to register for the event
URL:https://samed.org.za/event/regulatory-forum/
LOCATION:Virtual
CATEGORIES:Regulatory
ORGANIZER;CN="SAMED":MAILTO:communication@samed.org.za
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20251104
DTEND;VALUE=DATE:20251106
DTSTAMP:20260727T183503
CREATED:20250901T214100Z
LAST-MODIFIED:20250901T214100Z
UID:15753-1762214400-1762387199@samed.org.za
SUMMARY:MedDevReg AfriSummit\, Cairo - Egypt
DESCRIPTION:SAMED is a proud AfriSummit 2025 association partner. \nAfriSummit fosters collaboration to improve Medical Device regulations for the health of all Africans. As a premier platform for knowledge exchange and thought leadership in Regulatory Affairs\, it connects industry specialists\, policymakers\, and regulatory authorities. \nMedDevReg AfriSummit will spotlight critical medical device and IVD regulations\, leveraging case studies\, interactive presentations\, and engaging discussions. Attendees will gain valuable insights into tailored regulatory strategies for product placement across diverse African markets. Don’t miss this opportunity to navigate the evolving landscape of medical device regulation and drive impactful change across the continent.  Read more and register …
URL:https://samed.org.za/event/meddevreg-afrisummit-cairo-egypt/
CATEGORIES:Regulatory
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20250916T100000
DTEND;TZID=Africa/Johannesburg:20250916T120000
DTSTAMP:20260727T183503
CREATED:20250624T085535Z
LAST-MODIFIED:20250902T131159Z
UID:15473-1758016800-1758024000@samed.org.za
SUMMARY:Regulatory Forum: Insights and Updates Across the Medtech Regulatory Landscape
DESCRIPTION:We are pleased to invite you to the next Regulatory Forum where we will provide key updates on the EU MDR and IVDR (TBC)\, newly published guidelines and forms\, and insights from the SAMED Regulatory Committee. \nWho Should Attend? \n\nRegulatory Professionals\nQuality Assurance Professionals\nAnyone involved in managing\, overseeing or ensuring compliant regulatory practices in the organization\n\nAttendance \n\nSAMED Members & Code Signatories: Free of charge.\nNon-Members & Non-Code Signatories: Please contact alwi@samed.org.za for the cost to attend the event.\n\nRegistration \n\nClick Here
URL:https://samed.org.za/event/regulatory-forum-2/
LOCATION:Virtual
CATEGORIES:Regulatory
ORGANIZER;CN="SAMED":MAILTO:communication@samed.org.za
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20250722T100000
DTEND;TZID=Africa/Johannesburg:20250722T120000
DTSTAMP:20260727T183503
CREATED:20250623T093057Z
LAST-MODIFIED:20250721T110331Z
UID:15345-1753178400-1753185600@samed.org.za
SUMMARY:Regulatory Forum: Healthcare Coding 101
DESCRIPTION:We are excited to extend an invitation to you for the upcoming Regulatory Forum where we will dive into the complexities of healthcare coding. Attending the event will be beneficial for anyone involved in managing and overseeing regulatory practices in the organization. \nAgenda \n\nOverview of Coding in Healthcare | Carol Garner\, GCMS\nIntroduction to GMDN | Deniz Bruce & Dr Barry Daniels\, GMDN Agency\nNAPPI Codes Update & Relevance for Medtech Companies | Krish Pather\, Medikredit\n\nSpeaker Information \n⁠Carol Garner | Deniz Bruce | Dr Barry Daniels  | Krish Pather \nRegister Now
URL:https://samed.org.za/event/samed-regulatory-forum-healthcare-coding-101/
LOCATION:Virtual
CATEGORIES:Regulatory
ORGANIZER;CN="SAMED":MAILTO:communication@samed.org.za
END:VEVENT
END:VCALENDAR