ecosystem to join them for the first Medical Device Stakeholder Forum event for 2022. The session was hosted by Dr. Michelle Mulder Executive Director, Grants Innovation and Product Development at the South African Medical Research Council who reported back on the results of the South African Medical Devices Landscape Analysis undertaken by the SAMRC and collaborators.
Medical Device Establishment License Renewal are due five years after the original license was issued by SAHPRA.
New Medical Device Regulations have been published for comment.
SAHPRA have issued a revised version of the guideline on Classification of Medical Devices as Version 5.
Hand sanitizer, also called hand antiseptic, handrub, or handrub, agent applied to the hands for the purpose of removing common pathogens
Designating the Medical Device Sector has been a “priority” for some time but more pressure has to be placed on the Department of Trade and Industry to move ahead and assist the sector in reaching its full potential
South Africa needs to test 12 times more people per day for the new coronavirus than it currently does. Our testing plan can only do this if we use a wider range of tests – including controversial ones.
The coronavirus (Covid-19) outbreak has revealed both the strengths and weaknesses of South Africa’s healthcare system. On the other hand, the Covid-19 pandemic presents a greater opportunity to develop South Africa’s health sector value chain.
The argument by the chairperson of Parliament’s Health Committee, Dr Sibongiseni Dhlomo, that citizens should not fear the unknowns of the National Health Insurance is disturbing. Government’s virtual absence of technical policy analysis since NHI became official policy is exactly that type of unknown that is grounds for great alarm.
ISO13485 Certification
SAHPRA recently announced that the Section 36(1) Exemption requiring medical device companies to be ISO13485 Certified by the time that they renewed their Medical Device Establishment Licenses for a further three years.