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
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.
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.
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.
Regulatory challenges with rapid rise...
The article from MedicalBrief highlights the rapid integration of artificial intelligence (AI) into medical devices. This