South Africa Regulatory Framework Medical Device registration

South African Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in South African market:

Major Regulations

Classification of Medical Devices and IVDs 2016
Hazardous Substances Act – regulations regarding electromedical devices1993
Medical Devices and IVDs Essential Principles of Safety & Performance2016
Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)2016

General Guidance Documents

General Informaiton Medical Devices and IVDs 2014

Specific Guidance Documents

Document Year
Guideline For A Licence To Manufacture, Import, Export Or Distribute Medical Devices & IVDS 2016
Requirements with regard to the application for a licence to import, manufacture or fully refurbish any listed electromedical device 1973

Forms and Applications

Application for a License to Conduct Clinical Trials on a Locally Manufactured Listed Electromedical Product 2014
Application for a License to Import a Listed Electromedical Product for Clinical Trials 2014
Application for a License to Import a New Listed Electromedical Product 2014
Application for a License to Manufacture or Fully Refurbish a Listed Electromedical Device 2014
License Application (.XLS) 2016

Additional Information

Licensed Electromedical Devices – List of licensed devices up to May 2011 2011


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