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Medical Devices and in Vitro Diagnostics Application Forms

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
GLF-MD-06BLicence Application Medical Device Wholesaler Form, 28/08/20233xlsxDownloadapplication-forms formmedical-devices
GLF-MD-06CLicence Application to Import Distribute or Export Medical Devices, 22/11/20233xlsxDownloadapplication-forms formmedical-devices
GLF-MD-06ALicence Application Medical Device Manufacture, 22/11/20233xlsxDownloadapplication-forms formmedical-devices
Notice Regarding Medical Devices Application Forms

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:

  • The Compact Disc (CD) Requirements
  • Any reference to MCC
  • The submission of printed copies and/or hard copies

 

 (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

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