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 |
|---|---|---|---|---|---|---|
| Guideline for Licence Applications for Non-ionising Radiation Medical and Non-medical Devices Classified as Listed Electronic Products | 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. | 14 November 2025 | 14 December 2025 | Please submit comments using the comment form. The comments should be submitted to Colbert.Ditsepu@sahpra.org.za | Download comment Form | Download Document for Comment |
| Guideline for the Application of a License to Install, Use, Operate, and Apply for Magnetic Resonance Imaging (MRI) | The purpose of this document is to guide applicants seeking a license to install and use Magnetic Resonance Imaging (MRI) equipment. It outlines the necessary processes involved in applying for a license, the required supporting documents, and safety requirements. This guideline represents the minimum standards set forth by the South African Health Products Regulatory Authority (SAHPRA) for submitting applications to install and use MRI equipment. | 14 November 2025 | 14 December 2025 | Please submit comments using the comment form. The comments should be submitted to Colbert.Ditsepu@sahpra.org.za | Download comment Form | Download Document for Comment |
| Guideline for submission of Extension applications | The guideline is intended to guide applicants who intend to submit extension applications for registration on the appropriate data required for submission. | 13 November 2025 | 13 December 2025 | Please submit comments using the comment form. The comments should be submitted to preregstatusupdates@sahpra.org.za | Download comment Form | Download Document for Comment |
| Guideline for Medical Device Certificate of Free Sale | 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 open market in South Africa, freely without restriction. | 11 November 2025 | 11 December 2025 | Please submit comments using the comment form. The comments should be submitted to mdqueries@sahpra.org.za | Download comment Form | Download Document for Comment |
| MEDICAL DEVICES RELIANCE GUIDELINE | This guideline is intended to provide information and outline the principles of reliance-based review for both premarketing and post-marketing regulatory activities in the regulation of medical devices, including IVDs. | 05 November 2025 | 05 December 2025 | Please submit comments using the comment form. The comments should be submitted to mdqueries@sahpra.org.za | Download comment Form | Download Document for Comment |
| Guideline for Variations Addendum for Human and Veterinary Medicines 1. Annexure A - Health Products Authorisation (CV) 2. Annexure B - PEM Quality Variations Classification Codes 3. Annexure C - CEM Clinical Variations Classification Codes 4. Annexure D - Names and Scheduling Variations Classification Codes 5. Annexure E - Inspectorate Variations Classification Codes 6. Annexure F - Biological Variation Classification Codes 7. Annexure G - Veterinary Variations Classification Codes | The South African Health Products Regulatory Authority (SAHPRA) has established specific requirements for the submission of amendments/variations to registered products, for human and veterinary medicines, as well as biologicals. This guideline should be read in conjunction with the relevant annexures and SAHPRA guidelines for each specific unit, as well as the latest/revised relevant guidelines and templates listed in Appendix A. The requirements specified in this guideline and its annexures, are aligned to the framework of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), as well as the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In doing so, SAHPRA will reflect global best practices in terms of the safety, quality and efficacy of health product regulations. | 01 October 2025 | 01 December 2025 | Please submit comments using the comment form. The comments should be submitted to Ketshepile.Serumula@sahpra.org.za or Postregqualityvariations@sahpra.org.za Note to stakeholders: An individual/separate "Guidelines for comment" form must be completed and submitted for each document for comment. | Download comment Form | Guideline for Variations Addendum for Human and Veterinary Medicines 1. Annexure A - Health Products Authorisation (CV) 2. Annexure B - PEM Quality Variations Classification Codes 3. Annexure C - CEM Clinical Variations Classification Codes 4. Annexure D - Names and Scheduling Variations Classification Codes 5. Annexure E - Inspectorate Variations Classification Codes 6. Annexure F - Biological Variation Classification Codes 7. Annexure G - Veterinary Variations Classification Codes |
| Guideline for Borderline Products | This guideline is intended to provide information on the process to be followed in caseswhere the appropriate regulatory pathway is unclear for specific products. | 05 September 2025 | 01 December 2025 | Please submit comments using the comment form. The comments should be submitted to gontse.moutloatse@sahpra.org.za | Download comment Form | Download Document for Comment |