South Africa : Diagnostics
South Africa does not have an official body that regulates medical devices. Electro-medical devices are an exception, which must be approved by the Radiation Directorate of the South African MoH. SAHPRA will oversee regulation of medical devices when implemented.
Clinical Trial Data Requirements
The application to conduct a clinical trial or investigation got an unregistered medical device or in vitro diagnostic needs to contain:
-CV of investigators
-Signed declaration of understanding and compliance with Good Clinica Practice by the applicant and all investigators
-Ethics committe informed consent and endorsement document
-Name and address of the institution where the clinical trial will be conducted.
Full instructions can be found in section 22 of the Medicines and Related Substances Acr, 1965 (Act No. 101)
Clinical Trials Import Authorization
Policy for importing, manufacturing, or refurbishing a electromedical device can be found here.
Importation information can be found in sections 5 & 6 of the Medicines and Related Substances Acr, 1965 (Act No. 101)
GMP standards are required for medical devices.
Insurance coverage is a prerequisite for IEC/IRB approval.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
7 clinical trials approved from June 2012 to June 2014.
Product Registration Data Requirements
An application will be made on the appropriate form obtained from the Registrar and be accompanied by:
-Screning form from the Registrar
-Proposed label for use, if applicable
-Copy of manufacturer license with Good Manufacturing Practice certificate issued by the regulatory authority from the country of origin of the medical device, if applicable
-Certified copy of the conformity assessment certificate, if applicable
-Certified copy of the manufacturer's evidence in support of conformity to the original manufacturer's essential principles, if applicalbe
-Safety, performance, and quality data
-Manufacturing site's proof of existence
All information will be in English
Further information can be found in section 11 of the Medicines and Related Substances Act, 1965 (Act No. 101)
Post Registration Pharmacovigilance Requirements
The certificate holder or applicant must inform the council of suspected adverse events reported to them within a timeframe determined by the council.
Post Registration Labeling Requirements
Labelling requirements are found in Section 8 of the Medicines and Related Substances Act 101 of 1965, which can be found here.
September 29, 2014.