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30 Mar

Posted at 11:23h in

The applicant is to ensure that all relevant fields are completed on the application form and that all supporting documentation is attached. Incomplete applications will be identified as deficient, and the evaluation review will not be progressed until deficiencies are addressed. A completed application...

03 Oct

Posted at 10:08h in

The purpose of the form is to guide SAHPRA’s holders of certificates of registration about the details required and elements to be considered in the process of signal notification and follow-up. This form should be used to notify signals and Follow-Up information on signals according...

13 Dec

Posted at 11:04h in

This document is intended to assist the holder of a medical device establishment licence (referred to as the “licensee)” and the holder of a certificate of Registration (HCR) in the reporting of an adverse event associated with the use of a medical device (including an...

23 Jul

Posted at 10:39h in

The checklist must be included in submissions that include variations for CTD conversions. This checklist should also be included as an annexe to the cover letter for the baseline sequence when converting from eSubmission to eCTD....

23 Jul

Posted at 10:37h in

Populate this information on a document that includes your company letterhead....