Medical Devices Archives

10 Apr Licensing Requirements for Outsourced or Contracted Activities for Medical Device Establishments

Posted at 13:10h in

This is intended to provide stakeholders with guidance and the requirements for medical device (including In Vitro Diagnostics (IVDs)) manufacturers, distributors and wholesalers who appoint or contract a third party to perform manufacturing, distribution or wholesaling activities on their behalf, for the purpose of placing...

31 Mar Medical Devices Registration Feasibility Study report

Posted at 15:01h in

The purpose of the Medical Device Registration Feasibility Study was to support the South African Health Products Regulatory Authority (SAHPRA) in advancing the implementation of a comprehensive regulatory framework for medical devices, including in vitro diagnostics (IVDs), within South Africa. The study aimed to evaluate...

27 Mar Application for Certificate of Free Sale for Medical Devices

Posted at 09:31h in

26 Mar Guideline for Medical Device Certificate of Free Sale

Posted at 15:05h in

This guideline is intended to provide guidance on obtaining a Certificate of Free Sale, which serves as confirmation that the listed medical devices, including in vitro diagnostic medical devices (IVDs), are legally sold or distributed in the market in South Africa, freely without restriction. It...

25 Mar Applications for Import of Medical Devices for Personal Use

Posted at 14:47h in

The purpose of this document is to provide guidance to members of the public who intend to import Medical Devices/ In-Vitro Diagnostics (IVD) into the country for personal use....

25 Feb Medical Devices Reliance Guideline

Posted at 11:36h in

This guideline outlines the principles and procedures for reliance-based review in both premarketing and post-marketing regulatory activities for medical devices, including in vitro diagnostics (IVDs). It defines the Regulatory Reliance pathways that the South African Health Products Regulatory Authority (SAHPRA) will use in making regulatory...

27 Jan Notification of an Update to the Product List(s) of a Medical Device Establishment Licence

Posted at 14:19h in

1.1 On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101...

27 Jan Amendment of a Medical Device Establishment Licence

Posted at 11:54h in

On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101...

18 Nov Core Business Escalation Procedure

Posted at 10:18h in

This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....

09 Sep Application for Clinical Investigation of Medical Devices

Posted at 10:44h in

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