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The guideline is intended to provide guidance with regard to the legal system of measurement in South Africa. The guideline reflects the requirements as stipulated in the Legal Metrology Act, 2014 (Act 9 of 2014), and the Measuring Units and Measuring Standards Act, 2006 (Act...

This document is intended to provide clarity on guidelines and applications for the licensing of medical device establishments. It reflects the current situation and will be regularly updated with changes in legislation and experience gained. It is important that applicants adhere to the administrative requirements to...

This guideline is intended to provide guidance to applicants regarding applications for registering co-packaged medicines. It represents the South African Health Products Regulatory Authority (SAHPRA) current thinking on co-packaging of medicines. SAHPRA reserves the right to request any additional information to establish the safety,...

This document has been prepared to serve as a guideline to the holders of certificate of registration/applicants on the Authority’s requirements regarding risk management plans for medicines, including biological medicines, in South Africa. It represents SAHPRA’s current thinking on the safety, quality and efficacy of...

This guideline document determines basic requirements and recommendations for radiation protection and safety in dental radiography applications....