South African Medical Devices 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 …

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, …

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 …

South Africa - Healthcare: Medical Devices and …

https://www.trade.gov/country-commercial-guides/south-africa-healthcare-medical-devices-and-pharmaceuticals

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 …

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 …

IN-DEPTH: The tangled web of medical …

https://www.spotlightnsp.co.za/2020/09/03/in-depth-the-tangled-web-of-medical-device-regulation-in-sa/

According to a list of licensed medical device establishments available on SAHPRA’s website, 1 392 medical device establishments have been licensed by …

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 …

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 …

(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 …

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