South Africa’s health department released draft regulations for general medicine that include new procedures for transferring a drug registration to a medical device registration.

Drugs and devices are required to be registered with the country’s Medicines Control Council (MCC), which operates through external experts. Information for a drug registration may be transferred to a medical device or in vitro diagnostic registration upon request, the draft regulation says.

Transfer applications must be made by the manufacturer’s authorized representative and must include the existing certificate, the reasons for the transfer, the proposed device classification, and the prescribed application fee. If the application is approved, the drug registration certificate will be canceled and the MCC will issue a new certificate for the device.