Document Number | Title | Categories | Date Updated | Version | Units | File Type | Link | doc_categories_hfilter | doc_tags_hfilter |
---|---|---|---|---|---|---|---|---|---|
GLF-MD-06B | Licence Application Medical Device Wholesaler Form | Application forms, Form | 28/08/2023 | 3 | Medical Devices | xlsx | Download | application-forms form | medical-devices |
GLF-MD-06C | Licence Application to Import Distribute or Export Medical Devices | Application forms, Form | 22/11/2023 | 3 | Medical Devices | xlsx | Download | application-forms form | medical-devices |
GLF-MD-06A | Licence Application Medical Device Manufacture | Application forms, Form | 22/11/2023 | 3 | Medical Devices | xlsx | Download | application-forms form | medical-devices |
Dear Visitor
In August 2023, SAHPRA revised and approved the 3 application forms for medical devices establishment licence. There were minor changes made to the Distributor and Manufacturer application forms, i.e.,
(a) The removal of the following:
(b) The SAHPRA address was also updated.
(c) The manufacturing activities that were previously included in the Distributor application form were also removed.
The only substantial change was made to the Wholesaler application form, with the new requirement to submit the product list as well as the change from a Word Format to an Excel sheet.
Applicants that have saved the application in the old format are urged to delete those copies, and make use of the updated application forms. The old format of the application forms will no longer be accepted beyond 15 May 2024.
Regards,
Medical Devices Unit