South Africa Blog Posts

New South African Medical Device Authority Established

EMERGO SUMMARY OF KEY POINTS:

  • The South African government has formed the South African Health Products Regulatory Authority (SAHPRA) to oversee the country’s medical device and drug markets.
  • SAHPRA is based on elements of South Africa’s Medicines Control Council (MCC).
  • The initial period of implementing the new South African medical device regulatory system ends in August 2017.
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South African Regulators Set Licensing Deadlines for Medical Device Companies

EMERGO SUMMARY OF KEY POINTS

  • The South African Medicines Control Council has set an August 2017 deadline for all domestic medical device manufacturers and distributors to register with the regulator.
  • Domestic device wholesalers have until February 2018 to register with the MCC.
  • The registration requirements do not apply to foreign companies, but they must still ensure that their South African importers obtain MCC licenses.
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New Medical Device Registration Requirements Issued in South Africa

EMERGO SUMMARY OF KEY POINTS:

  • New South African registration requirements for medical devices and IVDs appear to have taken immediate effect from December 9, 2016.
  • Registration will initially be required only for devices participating in South Africa’s public tender system.
  • The Medicines Control Council (MCC) will continue requiring licensing of local manufacturers, distributors and importers in order to import devices into South Africa.
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South African Medical Device Regulatory System Set for Implementation

The South African government has set an August 2016 implementation date for registration of domestic medical device manufacturers, importers and distributors first proposed in late 2015.

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South African Authorities Publish Additional Draft Regulations for Medical Devices

South Africa’s Department of Health has released new draft regulations for medical devices and IVDs that accompanies proposed rules issued by the government in 2014.

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South African Draft Regulations based on IMDRF Principles Released

The South African Medicines Control Council (MCC) has issued draft regulations as well as Essential Principles for the mandatory registration of medical and in vitro diagnostic devices. Currently, only listed electro-medical devices and devices with pharmaceutical components require registration in the country.

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South African Regulators Publish Draft Medical Device and IVD Regulation

 

The South African Department of Health has published draft regulations for the country’s medical and in vitro diagnostic (IVD) device market for a three-month public comment period.

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