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 |
|---|---|---|---|---|---|---|
| Policy Position of SAHPRA on Enabling Local Manufacture | Policy Position of SAHPRA on Enabling Local Manufacturer comments. | 17 September 2024 | 17 December 2024 | Submit via both: | Download Form | Download Document for Comment |
| SAHPGL-MD-16 - GUIDELINES ON CLINICAL EVALUATION OF MEDICAL DEVICES | Medical device Clinical investigation /evaluation guidelines for public comment. | 18 November 2024 | 20 January 2025 | mdreg@sahpra.org.za | Download Form | Download Document for Comment |
| SAHPGL-MD-17 - GUIDELINE ON CLINICAL INVESTIGATION OF MEDICAL DEVICES | Medical device Clinical investigation /evaluation guidelines for public comment. | 18 November 2024 | 20 January 2025 | mdreg@sahpra.org.za | Download Form | Download Document for Comment |
| SAHPGL-MD-18 - POST MARKET SURVEILLANCE AND POST-MARKET CLINICAL FOLLOW-UP STUDIES | Medical device Clinical investigation /evaluation guidelines for public comment. | 18 November 2024 | 20 January 2025 | mdreg@sahpra.org.za | Download Form | Download Document for Comment |
| GLF-MD-17A - Application for Clinical Investigation of Medical Devices | Application for Clinical Investigation of Medical Devices for public comment. | 18 November 2024 | 20 January 2025 | mdreg@sahpra.org.za | Download Form | Download Document for Comment |