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The application form for import of Research Use Only (RUO) and Investigational Use Only (IUO) medical devices, including in vitro diagnostic (IVD) medical devices....
This is a form to report ADRs in clinical trials....
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...
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...
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...