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

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 days 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.



Interested in obtaining fast market approval for your medical device or IVD in South Africa? REQUEST A FREE QUOTE>

For more information on registration in South Africa, check out the following articles on our blog:
Country at a Glance: South Africa
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