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Medical Devices › License Applications

Smart & Biggar

Medical Devices updates: Annual performance report, new guiding principles for PCCPs for machine learning-enabled medical devices,...

Smart & Biggar on

Medical Devices Directorate Performance Annual Report - In September 2023, Health Canada published the Medical Devices Directorate Performance Annual Report for April 1, 2022, through March 31, 2023. The report provides...more

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

Medical devices – South Africa's changing landscape

Hogan Lovells on

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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