According to Jeremy Maggs SAHPRA plans to halve medicine approval times to boost local manufacturing in
According to Jeremy Maggs SAHPRA plans to halve medicine approval times to boost local manufacturing in
In light of a recent Lancet Global Health study highlighting substandard anti-cancer medications in several Sub-Saharan African countries,
A well-structured QMS integrates systems, processes, and people, ensuring compliance with international standards like ISO 13485 and national regulations such as those outlined by the South African Health Products Regulatory Authority (SAHPRA). This article explores the significance of these three pillars—systems, processes, and people—in building and maintaining an effective QMS for medical device distributors.
On January 17, 2022, Dr Boitomello Semete wrote: “Due to the delay in accreditation of South African
SAHPRA have issued a revised version of the guideline on Classification of Medical Devices as Version 5.
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.
Here are the over-the-counter codeine containing medicines you may need a prescription for in future – including Adcodol and Nurofen Plus
SAHPRA published three position statements on medical devices on 23 December 2019.
In a Proclamation published in the Government Gazette 442773 published 18 October 2019, the President has referred matters relating to maladministration at SAHPRA to the SIU.
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.