Medical Devices Archives - Page 3 of 12

19 May Guideline for Preparation of a Site Master File (SMF) for Wholesalers of Medical Devices

Posted at 10:50h in

This document serves as a guideline to assist applicants to comply with the requirements for a Site Master File (SMF) regarding the wholesaling of medical devices (including In vitro diagnostics (IVDs)). The South African Health Products Regulatory Authority (SAHPRA) is committed to ensure that all...

14 May POLARx and POLARx FIT Cryoablation Catheters, POLARSHEATH Steerable Sheaths, and SMARTFREEZE Consoles

Posted at 19:06h in

Company name & Address: Material Description Material Number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Boston Scientific No. 8 Anslow Crescent Anslow Office Park Bryanston 2021 CRBS SMARTFREEZE CRYO Console M004CRBS4000 PXC00144 N/A Not available 18 August 2021 Class I Type C 06 May 2026 CRBS POLARX BALLOON CATHETER ST 28MM OUS M004CRBS2000 34158824 CRBS POLARX FIT BALLOON CATHETER ST OUS M004CRBS2010 33791785 CRBS POLARX FIT BALLOON...

07 May OXOID™ Agglutinating Sera, Salmonella 9-0

Posted at 11:09h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Bioweb (Pty) Ltd Ridgeview Office Park 248 Kent Avenue Unit 10 Randburg 2194 N/A 6253410 02 June 2028 2ml Not available Class III Type C 04 May 2026 Brief description of the problem (reason for recall) This recall has been initiated following an internal technical investigation, which determined...

28 Apr Kiwi Complete Vacuum Delivery System

Posted at 17:03h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Pharmaco Distribution 91 Protea Road Chislehurston Sandton 2196 N/A 251485 23 October 2027 1 sterile unit per pack 22 December 2025 Class I Type B 17.April.2026 This recall is being conducted due to a manufacturing defect that may result in breakage of the handle...

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...

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