The South African Health Products Regulatory Authority has gazetted a revised fee schedule for medical device registrations and licence applications, reflecting an average 18% increase across all device classes to fund SAHPRA's accelerated capacity building programme and reduce the existing application backlog.
Read more →The World Health Organization has announced the expansion of its Medical Device Prequalification Programme to cover reusable surgical instruments, prioritising forceps, retractors, and laparoscopic tools used in essential surgical procedures. Applications from manufacturers in low- and middle-income countries will receive expedited assessment.
Read more →Health Canada has initiated a Class II recall of approximately 2,800 CardioSync 7 ambulatory cardiac monitors following reports of a firmware defect causing intermittent failure to store ECG data segments during high-movement activities, potentially resulting in missed arrhythmia events in up to 3% of recordings.
Read more →The European Commission has confirmed that mandatory submission of Unique Device Identification data to EUDAMED's UDI database module will apply to all Class III and Class IIb implantable devices from 26 September 2026, following a final six-month extension granted in December 2025 due to notified body capacity constraints.
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