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Recognising that an effective and efficient CRO covers their clients regional physical presence, OnQ is delighted to announce it has secured premises in Durbanville, greater Cape Town region.

Occupancy was effective January 2017.07.03
  
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NEW MEDICAL DEVICE REGULATIONS IN SOUTH AFRICA!

The South African Department of Health has issued new regulatory requirements covering both medical devices and in vitro diagnostic (IVD) devices.

The regulations are based heavily on guidance and principles of the International Medical Device Regulators Forum (IMDRF) and its predecessor organization, the Global Harmonization Task Force (GHTF); the new rules appear to take effect immediately.

Based on an initial analysis of the new regulations, registration with the South African Medicines Control Council or MCC is for now required only for devices whose manufacturers and sponsors participate in the country’s public tender system. However, the MCC has the authority to impose registration requirements at its discretion for devices not participating in public tenders, as well.

“It appears that the South African Department of Health eventually wants all devices to be registered through a formal registration system, but is starting slowly with devices that are sold in public tenders,” says Brian Goemans, Emergo Senior Consultant and Country Manager for South Africa.

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