Medical Devices Archives

23 Jul Contact Details for Guideline No. SAHPGL-MD-03 Medical Device vigilance: Adverse Events Reporting for Licence Holders

Posted at 11:37h in

This document provides contact details for reporting adverse events in accordance with the latest version of Guideline No. SAHPGL-MD-03 accessible on SAHPRA Website, Field Safety Corrective Actions. It also includes contact information for medical devices recalls, including In vitro diagnostics (IVDs)....

23 Jul Homechoice Automated PD set with cassette and 4-Prong luers

Posted at 11:31h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Adcock Ingram Critical Care 1 Sabax Road Aeroton Johannesburg 2013 South Africa N/A 25L02T005 25L06T017 26A02T005 25L02T005 (NOV 2030) 25L06T017 (NOV 2030) 26A02T005 (DEC 2030) 1’s 25L02T005(21 APR 2026) 25L06T017 (09 APR 2026) 26A02T005 (22 APR 2026) Class III Type C 20 July 2026 Brief description of the problem (reason for recall) Adcock Ingram...

25 Jun Application to Import Section 21 Ruo Medical Devices Including IVDs

Posted at 13:50h in

The application form for import of Research Use Only (RUO) and Investigational Use Only (IUO) medical devices, including in vitro diagnostic (IVD) medical devices....

25 Jun Communication on Research Use Only (RUO) and Investigational Use Only (IUO) Medical Devices including In Vitro Diagnostic Devices (IVDs)

Posted at 13:46h in

This document is intended to provide communication to stakeholders on the regulatory requirements and classification of Research Use Only (RUO) and Investigational Use Only (IUO) medical devices, including in vitro diagnostics (IVD)....

15 Jun Afterwash (Diphoterine Solution)

Posted at 15:17h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date PRISM INTER AFRICA CC 26 CALEDON STREET INDUSTRIAL DARLING 7345 N/A LE660101 LV360201 28/01/2028 23/02/2028 1’s 10/02/2026 16/03/2026 Class II Type B 03 June 2026 Brief description of the problem (reason for recall) This recall is initiated due to the presence of white flakes, floating at the surface of the...

01 Jun Regulatory Requirements for Medical Devices Electronic Instructions for Use (e-IFU)

Posted at 10:44h in

The Medicines and Related Substances Act No. 101 of 1965 (Act 101 of 1965) as amended, read in conjunction with the General Regulations on Medical Devices, published in Government Gazette Notice 40480, No.1515 of 09 December 2016, provides for the regulatory oversight on labelling of...

01 Jun Bobby Balloon Guide Catheter

Posted at 08:59h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Intramed 12 Huklingham Road Dunkeld West 2196 N/A See Recall Letter Not Available 1 Not Available Class II Type C 19 May 2026 Brief description of the problem (reason for recall) This action is based on complaints identified through established proactive post-market surveillance processes that...

01 Jun CRE™ Wireguided Balloon Dilatation Catheter

Posted at 08:58h in

Company name & Address: registration 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 N/A See Recall Letter See Recall Letter 1 unit 18 August 2021 Class II Type B 27 May 2026 Brief description of the problem (reason for recall) Boston Scientific is initiating recall of CRETM Wireguided, CRE...

01 Jun Mx-ava 500 Mpat Syringe Set Multi Patient

Posted at 08:56h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Cardio Tech (Pty) Ltd t/a Cardaxes Stand 208 C, Hoogland Ext 44, Corner Epsom Avenue and Malibongwe Drive, Boundary Park, Northriding, Randburg, 2169 N/A 251702 21 April 2027 1 set 22 April 2026 Class II Type C 18 May 2026 Brief description of the...

01 Jun Optase Dry Eye Intense Drop (Glycerol 0.2%)

Posted at 08:54h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Isoclear Pty Ltd Block C The Village, Block A -1St Floor, c/o Oberon & Glenwood Roads Faerie Glen,0043 N/A 3V35 3V36 5V45 9V12 31 August 2026 30 September 2026 31 March 2027 31 March 2027 1’s 14 May 2025 14 May 2025 22 August 2025 20 August 2025 Class II...

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