The document, ZA-SAHPRA CTD eSubmission Specification June 2024, v3.0 is out for applicant comment with a response deadline of Wednesday, 03 July 2024. Download the Document for Comments here. Comments deadline: 03 July 2024...
This document is intended to provide contact details for communicating reportable adverse events, as per Guideline SAHPGL-MD-03, as well as contact details for any Recalls and Market actions for medical devices (including IVDs). Reportable adverse events reports must be emailed to mdvigilance@sahpra.org.za and copy (cc) Puseletso.Mogano@sahpra.org.za...
This communication is intended to provide an update on the progress of the Regulatory Information Management System (RIMS) deployment at the South African Health Products Regulatory Authority (SAHPRA)....
SAHPRA intends to conduct a voluntary feasibility study for medical device registration to validate the proposed process for registration of medical devices. The medical device registration feasibility study is only for medical devices intended for human use and aims to provide an approach to benefit stakeholders,...
SAHPRA has taken office at the New Agents Building, 7th floor, Room 726. SAHPRA is instituting a physical resubmission process to address the backlog and new incoming shipments. Operating hours will be 08h00 to 15h45, in line with Border Management Agency (BMA) office hours....
The South African Health Products Regulatory Authority has experienced challenges in exercising its function to review and stamp the documents of incoming shipments of medicines, medical devices and scheduled substances at the OR Tambo International Airport port of entry. The delay has been caused by a...
The SAHPRA fees that have been gazetted are implementable from 22 December 2020. The fees outlined in most cases are self-explanatory, however in the case of fees payable for technical amendments related to quality, there are several options listed which require clarity and hence the...
Payment of retention fees for the year ending 31 March 2024 in respect of medicines and/or various licences registered until 31 December 2023....
Your attention is drawn to the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, making provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences...
