The “Documents for Comments” area serves as a space for stakeholders to engage with SAHPRA’s regulatory processes. Your input is valuable as we strive to ensure transparency and inclusivity in our decision-making. Please take the time to review the documents and share your comments. Together, we can contribute to the continuous improvement of healthcare regulation in South Africa.
| Document Name | Description | Date Published | Comments Deadline date | Submit to | Comments Form | Document for Comment |
|---|---|---|---|---|---|---|
| SAHPGL-MD-02 - Guideline for Handling Field Safety Corrective Actions | This guideline provides guidance to applicants regarding the handling of Field Safety Corrective Action(s) (FSCAs), and the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality and performance of medical devices, (including IVDs). SAHPRA reserves the right to request any additional information to establish the safety, quality and performance of a medical device, (including IVDs) and may make amendments in keeping with the knowledge which is current at the time of consideration of data that has been submitted regarding any Field Safety Notice. | 31 July 2026 | 31 October 2026 | mdenquiries@sahpra.org.za | Download comment Form | Download Document Download Field Safety Corrective Action Form |
| SAHPGL-INSP-07 - Guidelines on Submission of Once-off Deviations | This is a guideline that describes the process that shall be followed when applying for a Deviation (Once-Off) in line with Regulation 53(2) of the Medicines Act. | 03 July 2026 | 03 October 2026 | douwlina.nel@sahpra.org.za | Download comment Form | Download Document |
| SAHPGL-RDN-XR-01 - Guidelines on Requirements for Licence Holders With Respect to Quality Control Tests for Medical Diagnostic X-ray Imaging Systems | The goal of quality assurance (QA) is to improve patient care. Quality control (QC) refers to the specific tests required to ensure effective and safe equipment performance. QC tests check the performance of the equipment under routine clinical conditions, following established protocols for facilities, equipment, and procedures. | 25 June 2026 | 25 September 2026 | Phineas.Mahlangu@sahpra.org.za and phumlani.sithole@sahpra.org.za | Download comment Form | Download Document |
| SAHPGL-RDN-INSP-04 - Guideline on the Requirement for Establishment of Dose Reference Levels | The objective of this guideline is to provide an overview of the use of Diagnostic Reference Levels (DRLs) in the context of radiation protection in medicine. The international basic safety standards are the international benchmark for radiation safety, and monitoring of patient dose is a key requirement towards optimisation. These standards further require that patient dosimetry surveys should be performed for diagnostic procedures and interventional procedures in radiology, and that the results obtained must be compared with the established national DRLs. | 25 June 2026 | 25 September 2026 | Phineas.Mahlangu@sahpra.org.za and phumlani.sithole@sahpra.org.za | Download comment Form | Download Document |
| SAHPGL-INSP-01 - Guideline for Post-importation Testing | This guideline outlines requirements for Post Importation Testing in South Africa. The guideline should not be regarded as an exclusive approach. | 14 May 2026 | 14 August 2026 | pharmalicqueries@sahpra.org.za | Download comment Form | Download Document |
| SAHPGL-INSP-10 - Guideline on Regulatory Enforcement Actions for the Pharmaceutical Industry | This Guideline provides a framework for regulatory enforcement actions in the pharmaceutical industry. It outlines steps from identifying non-compliance to applying corrective measures, enforcement actions, withdrawals and escalations. The process ensures regulatory that are risk-based, proportionate, transparent, and consistent. | 04 May 2026 | 04 August 2026 | inspectorate@sahpra.org.za | Download comment Form | Download Document |