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: 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.
Licenses are typically issued within three to five days of receiving correct documentation.
Licenses should be renewed annually.
An authorized representative is required.
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