South Africa Regulations Medical Devices

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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 …

South African Medicines and Medical Devices …

https://www.gov.za/documents/south-african-medicines-and-medical-devices-regulatory-authority-act

The repealed South African Medicines and Medical Devices Regulatory Authority Act 132 of 1998 intended: to provide. for the regulation and registration of medicines intended for …

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 Registration and Approval in South Africa

https://arazygroup.com/medical-device-registration-south-africa/

SAHPRA License – Initial Registration (including radiation control license if applicable): USD 1010. SAHPRA License – Annual Fee: USD 282. LOCAL FEES …

Medical Device Regulations - SAHPRA - South …

https://sahpra.org.za/wp-content/uploads/2019/09/20161209_Medical-Device-Regulations_Gov-Gazette-40480.pdf

REGULATIONS RELATING TO MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVDs) I, Dr A Motsoaledi; the Minister of Health has, …

Medical device regulation in South Africa: The Medicines …

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

The enactment of the new regulations is a positive development for the South African medical device industry. However, the impact of the regulations will …

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 advertised …

CLASSIFICATION of MEDICAL DEVICES and IVDs …

https://sahpra.org.za/wp-content/uploads/2020/01/Classification_Medical_Devices_IVDs_Nov19_v2.pdf

The registration of medical devices and IVDs in South Africa is governed by the provisions and ... The medical devices regulatory framework has a classification system for …

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 manufactured or sold …

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/

Historically, medical devices have been under-regulated both in South Africa and globally. This has left the door open for the sale and use of substandard and …

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