South African Medical Device Regulation

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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, …

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/

Now that South Africa’s Minister of Health has appointed the board of the new South African Health Products Regulatory Authority (SAHPRA), we can expect the …

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 …

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 use or …

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 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 …

Medical Device Registration in South Africa - omcmedical.com

https://omcmedical.com/medical-device-registration-in-south-africa/

South African Health Products Regulatory Authority (SAHPRA) Medical Device Regulation Medicines and Related Substances Act, 1965 Regulatory Guidance for …

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