The South African Health Products Regulatory Authority (SAHPRA) is the new regulatory authority. The following recently published SAHPRA documents for your attention:

 

1. Revised Clinical Trials Form (CTF1)

2. Revised six-monthly Progress Report Form

3. Post Clinical Trial Access Guideline

4. Participant Compensation Model

    

NB  Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)

Regulations were published in government gazette on 9 Dec 2016 and are now in force. Download the regulations here.

 

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