Medical Devices Archives

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...

01 Jun Residual Barrier Technology (RBT) Protectus Med 1lt

Posted at 08:50h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Axim AXIM House 63 Old Pretoria Road Halfway House Ext.2 Midrand South Africa N/A 03/1M260411/01 February 2028 1 litre 10 February 2026 Class II Type C 19 May 2026 Brief description of the problem (reason for recall) This recall is initiated due to testing of the product in...

19 May TCNTM (Thermo Couple Nitinol) and CSKTM (Cosman Straight Kit) Reusable Radiofrequency (RF) Electrodes

Posted at 15:07h in

Company name & Address: Product Name(s) 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 CSK TC ELECTRODE 10CM N/A All Not available Not available Not available Class II Type B 14 May 2026 CSK 10CM TC ELECTRODE WITH 3M CABLE CSK TC ELECTRODE 15CM CSK 15CM TC ELECTRODE WITH 3M CABLE CSK...

19 May Mixing Bowl and Spatula, 20-pack

Posted at 15:04h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date ZimmerBiomet S. A.Pty Ltd 2 Bridal Veil Road Waterfall DistributionCampus 2066 N/A 82395238 82395239 82395240 85390022 85390023 85390024 85390025 85390026 85390027 85390028 85390029 85682882 86970970 Not Available 20 pack August 2025 Class II Type C 14 May 2026 Brief description of the problem (reason for recall) This recall has been initiated issue is related to...

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...

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