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

Regulation	Year
Classification of Medical Devices and IVDs	2016
Hazardous Substances Act – regulations regarding electromedical devices	1993
Medical Devices and IVDs Essential Principles of Safety & Performance	2016
Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)	2016

General Guidance Documents

Document	Year
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

Document	Year
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

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

Doubts?

Reach out to us and we will help you clarify your situation