Regulation Of Medical Devices In South Africa

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Medical Devices - SAHPRA

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

Medical Devices The medical device unit of SAHPRA regulates the licencing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non …

Medical device regulation in South Africa: The Medicines …

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

Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015 The Medicines and Related Substances …

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/

Sep 9, 2020

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/

A medical device means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent a) used or purporting to be suitable for …

Regulatory Framework for Medical Devices in South …

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

•advising users of an issue with a medical device Contact the Medical Device Unit When the need for a recall of a medical device supplied in or exported from South …

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 …

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 …

ACTS AND REGULATIONS - SAHPRA

https://www.sahpra.org.za/acts-and-regulations/

The South African Health Products Authority (SAHPRA) is the regulatory authority of South Africa responsible for the regulation of health products intended for human and animal …

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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