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.
While much remains unclear about the rationale for, and function of, the Office of Health Products Procurement(OHPP), the NHI Bill nevertheless gives us some important pointers.
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.
The recent Constitutional Court ruling on cannabis does not mean people can use it to manufacture and sell their own medicines
Wesgro hosts stakeholder engagement to discuss the investment potential of the medicinal cannabis industry Wesgro, the official
PRETORIA – The Department of Health Head of Corporate Services Tiny Rennie stated the department is working on