: 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