Guideline Archives

19 May Guideline for Preparation of a Site Master File (SMF) for Wholesalers of Medical Devices

Posted at 10:50h in

This document serves as a guideline to assist applicants to comply with the requirements for a Site Master File (SMF) regarding the wholesaling of medical devices (including In vitro diagnostics (IVDs)). The South African Health Products Regulatory Authority (SAHPRA) is committed to ensure that all...

14 Apr Guidelines for Submission of Plasma Master File

Posted at 15:13h in

These guidelines provide recommendations for manufacturers seeking to submit Plasma Master Files to support the quality of the starting materials for Plasma-Derived Medicinal Products (PDMP). These apply to applications for the registration or variations of PDMP. These guidelines emphasise the South African Health Products Regulatory...

01 Apr Medicines Online Directory Toolkit OTC and prescription (Rx)

Posted at 14:01h in

The South African Health Products Regulatory Authority (SAHPRA) launched the Online Medicines Directory for over-the-counter (OTC) medicines in June 2022. The platform, available at www.medsinfo.sahpra.org.za, serves as a single, trusted source of information for patients, consumers, and healthcare professionals on all medicines approved by SAHPRA. Phase...

31 Mar Guideline for Transportation Security for Radioactive Material

Posted at 14:54h in

This guideline specifies the basic security conditions for obtaining a transport authority for Group IV hazardous substances as defined in the Hazardous Substances Act 15 of 1973, referred to in this guideline as radioactive material. This represents the guidance of the South African Health Products...

30 Mar Guidelines to Clinical Trials in Pregnancy and Lactation

Posted at 09:11h in

This document has been prepared as a guideline for preparing applications to conduct clinical trials in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on pregnancy and lactation for clinical research in South Africa. It is not intended as...

30 Mar Pre-clinical Testing Guidelines and Clinical Requirements for Phase I / First in Human (FIH) Studies

Posted at 09:08h in

This document has been prepared to serve as a guideline for the preparation of applications to conduct first-in-human (FIH) and Phase I clinical trials in South Africa. It is not intended as an exclusive approach, and SAHPRA reserves the right to request any additional information...

27 Mar Guideline for Liability Insurance for Clinical Trials

Posted at 14:53h in

This document has been prepared to serve as a guideline to clarify the requirements of insurance for those who conduct interventional clinical trials involving human participants and intend on making a submission for approval of a clinical trial by South African Health Products Regulatory Authority...

27 Mar Guideline for Remuneration of Volunteers in Phase 1 Clinical Trials

Posted at 13:52h in

This document has been prepared to serve as a guideline for applicants/investigators who wish to submit the application to conduct a clinical trial, application for additional sites, and additional investigators for an approved trial....

26 Mar Guideline for Medical Device Certificate of Free Sale

Posted at 15:05h in

This guideline is intended to provide guidance on obtaining a Certificate of Free Sale, which serves as confirmation that the listed medical devices, including in vitro diagnostic medical devices (IVDs), are legally sold or distributed in the market in South Africa, freely without restriction. It...

25 Feb Medical Devices Reliance Guideline

Posted at 11:36h in

This guideline outlines the principles and procedures for reliance-based review in both premarketing and post-marketing regulatory activities for medical devices, including in vitro diagnostics (IVDs). It defines the Regulatory Reliance pathways that the South African Health Products Regulatory Authority (SAHPRA) will use in making regulatory...

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