REGULATION
New regulator will also oversee medical devices
The new authority replacing the Medicines Control Council is expected to clear a backlog of more than 2,000 applications
Medical devices will now be regulated in SA, with the newly established regulatory body, the South African Health Products Regulatory Authority (Sahpra), replacing the Medicines Control Council (MCC) with effect from June 1. Until now, medical devices and complementary medicines have gone unregulated as the MCC could only deal with medicines. This gap was laid bare a few years ago when the Tara Klamp, a device used for medical circumcisions, split medical opinion following its application in KwaZulu-Natal. SA has the largest medical device market and manufactures a range of devices, although it is primarily reliant on imports from Germany and the US. Sahpra’s official existence comes as the government has finally signed the Medicines and Related Substances Amendment Act of 2008. However, the body is not yet operational as Health Minister Aaron Motsoaledi has yet to appoint a board. The Health Department wants Sahpra to be the solution to the extensive delays that beset the MCC, whic...
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