Medical Devices Regulations South Africa

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Medical Devices - SAHPRA

https://www.sahpra.org.za/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-IVD …

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 …

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, …

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 …

ACTS AND REGULATIONS - SAHPRA

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

The South African Pharmacy Council (SAPC) in terms of section 35A of the Pharmacy Act (Act No. 53 of 1974) regulates the practice of pharmacy within South Africa. SAPC …

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 device means …

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/

Except for the low-risk category (class A), manufacturers, importers, exporters, distributors and wholesalers i of medical devices and IVDs must be licensed …

Medical Device Regulation in Africa — Faces of digital health

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

Medical Device Regulation in Africa — Faces of digital health South Africa & Africa More Broady: What’s The State of Medical Device Regulation? By using this …

(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 …

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