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-INSP-RC-15 - Guideline for recall of a medical device (including IVDS) Act GLF-RC-INSP-15A - Recall Information Medical Device or IVD (INITIAL REPORT to Regulatory Authority) GLF-RC-INSP-15B - Post-recall Information Medical Devices IVDs _ FINAL REPORT to Regulatory Authority | This document has been prepared to serve as a recommendation to a holder of a Medical Device Establishment License (Licensee) / Holder of a Certificate of Registration (HCR) of a medical device (including an IVD) regarding the recall of medical devices (including IVDs), and the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality and performance of medical devices (including IVDs). | 05 October 2026 | 05 January 2027 | mokgadi.fafudi@sahpra.org.za | Download comment Form | Download Document |
| SAHPGL-PEM-VET-09 - Guideline for Professional Information for Veterinary Medicines (Category C) SAHPGL-PEM-VET-06 - Guideline on Reporting Adverse Drug Reactions to Veterinary Medicines GLF-PEM-VET-06A - Veterinary Medicines Adverse Drug Reactions (ADR) Reporting Form | 29 September 2026 | 16 November 2026 | pervetS21@sahpra.org.za | Download comment Form | Refer to the documents under the "Document Name" column | |
| Regulations regarding Fees payable in terms of the Provisions of the Hazardous Substances Act | The Minister of Health intends, in consultation with the Minister of Finance and the South African Health Products Regulatory Authority, in terms of Section 29(1 )(r) read together with Section 29(2)(a) and (4) of the Hazardous Substances Act, to make the Regulations in the Schedule. | 07 August 2026 | 07 November 2026 | Interested persons are invited to submit any substantiated comments or representations on the proposed regulations, to the Director-General of Health, Private Bag X828, Pretoria, 0001 (for the attention of the Director: Public Entities and Relations Management, mihloti.mushwana@health.gov.za and paul.tsebe@health.gov.za ) | N/A | Download Document |
| SAHPGL-CEM-02 - Guideline for Professional Information for Human Medicines (Categories A and D) | 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. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific technical guidance indicated in Category D medicine guidelines should be applied. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality, and efficacy of a medicine in keeping with the knowledge current at the time of evaluation. SAHPRA is committed to ensure that all registered medicines will be of the required quality, safety, and efficacy. Guidelines and application forms are available from the office of the Chief Executive Officer and the website. | 21 September | 06 November 2026 | preregstatusupdates@sahpra.org.za and Siphokazi.sibisi@sahpra.org.za | Download comment Form | Download Document |
| 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 |