Guideline Archives - Page 2 of 16

25 Feb Guideline for Licence Applications for Non-ionising Radiation Medical and Non-medical Devices Classified as Listed Electronic Products

Posted at 09:04h in

This guideline is intended to guide applicants wishing to submit applications for the listed electronic products. It represents the South African Health Products Regulatory Authority's (SAHPRA)’s current thinking on the safety, quality, and performance of the listed electronic products....

03 Feb Guidelines for distributors and transporters of sealed sources

Posted at 15:06h in

This guideline document deals with compiling and submitting sealed source monthly reports. It also deals with the cradle-to-grave racking process to account for all sealed radioactive sources that are used in South Africa. The tracking covers the manufacture, storage, use, transport, disposal (sale, transfer or...

17 Nov Guideline for Users of Ultra-portable X-ray Equipment

Posted at 12:50h in

This guideline sets out requirements and recommendations for radiation safety associated with the use of ultra-portable diagnostic X-ray equipment. It represents the South African Health Product Regulatory Authority’s (SAHPRA) current thinking on the safety, efficacy, and quality of X-ray equipment. The Hazardous Substances Act, 1973...

10 Nov Guideline for Destruction of Medicines and Scheduled Substances

Posted at 08:57h in

This document provides guidance regarding safe disposal and destruction of medicines and scheduled substances by health facilities in accordance with Regulation 44 of the General Regulations of the Medicines and Related Substances Act, 101 of 1965, and relevant waste legislation. To ensure the correct handling...

31 Oct Guideline for Labelling of Medicines Intended for Human Use

Posted at 14:48h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (Categories A and D) containing specified substances. Regarding Category D medicines, the guidance provided herein pertains to general content requirements. Any specific technical guidance indicated in...

27 Oct Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7

Posted at 17:36h in

All guidelines adopted by the South African Health Products Regulatory Authority (SAHPRA) from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) must be read in conjunction with the current, non-draft version of SAHPRA’s Guide to Good Manufacturing Practice for...

09 Oct SAHPRA ECTD Specification 3.1 and Guidance for Module 1 and Regional Information

Posted at 18:02h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration, as well as variations, of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained. It is important...

01 Oct Guideline on Traceability of Health Products

Posted at 14:31h in

The purpose of the document is to guide the implementation of global standards for product identification, data capture, and data sharing. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The implementation of unique...

09 Sep Post Market Surveillance and Post-market Clinical Follow-up Studies

Posted at 10:34h in

This guideline is intended to provide recommendations to Manufacturers, Importers, Exporters, Distributors, and Holders of certificates of Registration (HCR) of medical devices. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and performance of medical devices. It is...

09 Sep Guidelines on Clinical Evaluation of Medical Devices

Posted at 10:33h in

This guideline is intended to clarify the requirements of conducting a clinical evaluation of a medical device in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and performance of medical devices under clinical investigation. It...

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