South African Medical Device Regulations

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Medical Devices - SAHPRA

https://www.sahpra.org.za/medical-devices/

Licensing of Medical Device Establishments. An applicant may apply for one of three types of licences for medical device establishments: manufacturer (manufacture, pack, label, …

Medical device regulation in South Africa: The Medicines …

https://pubmed.ncbi.nlm.nih.gov/30004357/

The Medicines and Related Substances Amendment Act, 14 of 2015, has brought significant changes in the regulation of medical devices in South Africa. The …

Clinical Research Regulation For South Africa | ClinRegs

https://clinregs.niaid.nih.gov/country/south-africa

South African Health Products Regulatory Authority As stated in the MRSA, Proc20of2017, and ZAF-9, the South African Health Products Regulatory Authority (SAHPRA) is the …

South African Medicines and Medical Devices …

https://www.gov.za/documents/south-african-medicines-and-medical-devices-regulatory-authority-act

for the establishment of the South African Medicines and Medical Devices Regulatory Authority; for the control of orthodox medicines, complementary medicines, …

South Africa Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/south-africa/

South Africa Medical Device Regulations. Agency. All medical devices are regulated by Medicines Control Council (MCC). Medical Device Definition. A medical …

Regulatory Framework for Medical Devices in South …

https://www.saapi.org.za/download/presentation/ms-anfrea-julsing-keyter-sa-md-update-ar-adverse.pdf

South African Regulatory Road Map - Phased Implementation Regulation 21: ADVERTISING Only Class A and Class B medical devices and IVDs may be …

Regulation of Medical Devices in South Africa - Bowmans

https://bowmanslaw.com/insights/pharmaceuticals-healthcare/regulation-of-medical-devices-is-set-to-become-a-reality-in-sa/

SAHPRA will be a souped-up version of the Medicines Control Council (MCC), which it is replacing, and will have wide powers over the licensing and distribution of …

Medical Device Registration and Approval in South Africa

https://arazygroup.com/medical-device-registration-south-africa/

However, in addition to the SAHPRA license, the establishment must have a dedicated and registered facility to store the medical device, and list down all devices that …

(PDF) Medical Device Regulation in Africa - ResearchGate

https://www.researchgate.net/publication/347522722_Medical_Device_Regulation_in_Africa

PAHO has assigned a task to ECRI to develop and coordinate programs for medical device safety and regulation regulation for medical devices, single approval scheme similar to EU,...

Medical Device Regulation in Africa — Faces of digital health

https://www.facesofdigitalhealth.com/blog/medical-device-regulation-mdr-africa

You don't just know about the medical device regulation in South Africa. You're familiar with the MDR with the FDA. So how do you see that the space of medical …

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