On January 17, 2022, Dr Boitomello Semete wrote: “Due to the delay in accreditation of South African
On January 17, 2022, Dr Boitomello Semete wrote: “Due to the delay in accreditation of South African
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.
SAHPRA published three position statements on medical devices on 23 December 2019.
The US Food and Drug Administration has updated and finalized guidance to determine which mobile medical applications fall under medical device oversight requirements based on their functions.
Drugmakers in Africa’s largest pharmaceutical market may be asked to pay a “backlog fee” to help
Regulatory challenges with rapid rise...
The article from MedicalBrief highlights the rapid integration of artificial intelligence (AI) into medical devices. This