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Medical Devices and IVDs - Essential Principles of Safety and Performance
Please note that this is a third-party website. Juta has no control over the nature, content or availability of third-party websites, and shall not be liable, in any manner whatsoever, for any damages incurred through the use of third-party websites.
Classification of Medical Devices and IVDs
Classification of medical devices and IVDs
RECALL, ADVERSE EVENT and POST-MARKETING VIGILANCE REPORTING of MEDICAL DEVICES and IVDs (MCC 8.04, Aug 17)
Guidelines on the recall, adverse event reporting and post-marketing vigilance of medical devices and IVDS in South Africa
This guideline supplements the guideline on oversight and monitoring of clinical trials to clarify and define the rules of investigators in investigational studies of medical products.
Guidelines for a Licence to Manufacture, Import Export or Distribute Medical Devices and IVDs (MCC: 16.03, July 2016)
Recommendations or licensing requirements for the manufacture, importation, distribution and exportation of Class B, Class C and Class D medical devices. Please note that this is a third-party website. Juta has no control over the nature, content or availability of third-party…
Application form for a licence to wholesale or distribute medicines and Medical Devices and IVDs, Recommendations for an application for a licence to act as wholesaler or distributor of medicines and Medical Devices. GWP guidelines apply. Please note that this is…
Licence application to act as wholesaler of medical devices and IVDs in South Africa