Medical Devices Archives - Page 2 of 13

13 Aug ZS70658 – VAC TUBE CLOT ACTIV+GEL SEP 5mL (2 4mL)

Posted at 13:59h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Gen Analytica 54 Maxwell Drive North Office Park Block B Suite 34 Woodmead N/A A10015 A10016 N/A 1 set 22 April 2026 Class II Type B 12 August 2026 Brief description of the problem (reason for recall) This recall is initiated due to customer complaints received reporting potassium...

12 Aug Smart Bag Flexpack Acid Concentrates

Posted at 13:37h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Fresenius Medical Care – South Africa 9 Galaxy Road Linbro Park Sandton Johannesburg. N/A See Recall letter See Recall letter 1’s 2025/10/20 Class I Type B 07 August 2026 Brief description of the problem (reason for recall) The recall is being initiated as the distributor for certain...

12 Aug General Regulations Made in Terms of the Medicines and Related Substances Act 101 of 1965: Amendment to Regulation 6: Notice of Correction

Posted at 11:43h in

The South African Health Products Regulatory Authority (SAHPRA) wishes to inform all pharmaceutical industry stakeholders that an amendment to Regulation 6 was published in Government Gazette No. 55152, Notice No. 7780, on 7 August 2026 for implementation. The published amendment contained two aspects: first, the...

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...

Archive