Medical Device Registration and Approval in South Africa

General country-specific regulatory information is provided on this page for medical device registration and approval in South Africa. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including South Africa, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and classification in South Africa

REGULATORY AUTHORITY: Medical devices are regulated by the South African Medicines Control Council (MCC).  Currently, only electro-medical devices and single-use or disposal devices are regulated in South Africa, and licensing is typically based on recent CE certification.

TIMEFRAME: Licenses are typically issued within three to five months of receiving correct documentation.

LICENSE VALIDITY: Licenses should be renewed annually.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

ADDITIONAL INFORMATION: A new regulatory body overseeing the registration of all medical devices, the South African Health Products Regulatory Agency (SAHPRA), is expected to be instated shortly.

Last updated on May 11 2015.


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