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 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.



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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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