South African Medical Device Regulatory Requirements

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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, …

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 …

CLASSIFICATION of MEDICAL DEVICES and IVDs …

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

This guideline provides the classification rules for the classification of medical devices (NonIVDs) and - IVDs in South Africa. The aim of this Guideline is to assist …

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 …

Clinical Research Regulation For South Africa | ClinRegs

https://clinregs.niaid.nih.gov/country/south-africa

As per the SA-GCPs, the G-EthicsHR-ZAF, and the G-GPHlthCare, the informed consent form (ICF) and patient information sheet(s) are essential documents that must be …

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 …

SAHPRA - South African Health Products Regulatory …

https://www.sahpra.org.za/

The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulat... THE RANITIDINE-CONTAINING MEDICINES THAT ARE REGISTERED …

(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 …

South African Medicines and Medical Devices …

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

South African Medicines and Medical Devices Regulatory Authority Act 132 of 1998 [repealed] Files: Attachment Size 132 of 1998 The repealed South African Medicines …

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