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The South African pharmaceutical regulatory environment

Our local pharmaceutical environment is highly regulated.The most important legislative provisions are found in the Medicines Act and the Pharmacy Act....more

Substantial Changes to South Africa’s Medical Device Regulations Have Far-Reaching Impacts

Although medicines have always been heavily regulated in South Africa, medical devices have not. Recently, however, Medical Device Regulations have been issued to bring medical devices into the regulatory fold. Medical...more

Are We Due for a Makeover?

Many have questioned what affect a proposed legislative facelift, to the cosmetic industry, will have on manufacturers, retailers and, of course, on consumers. According to the Department of Trade and Industry, the total...more

Medical devices – South Africa's changing landscape

Subject to certain exceptions, medical devices have historically not been heavily regulated in South Africa.  Prescriptive requirements for medical devices were not in force and advertisers and marketers of medical devices...more

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