Regulations Medical Devices 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-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 …

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 …

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 …

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 …

What are the rules governing medical devices and IVDs …

https://www.linkedin.com/pulse/what-rules-governing-medical-devices-ivds-south-africa-victoria-clark

The South African Health Products Regulatory Authority (SAHPRA) has assumed the role of the then Medicines Control Council and is tasked with regulating the …

Regulatory, Pricing and Reimbursement: South Africa

https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-south-africa/

The legislation regulating the framework for the authorization, pricing and reimbursement of drugs, biologicals and medical devices include the Medicines and …

(PDF) Medical Device Regulation in Africa - ResearchGate

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

This paper focuses on the development of an affordable and sustainable system for medical device regulations to provide safe, effective and quality healthcare products for Africa.

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