What is the regulatory status of ECG Buddy in global markets? <p><span style="font-family:Arial, Helvetica, sans-serif;font-size:18px;">ARPI's products are approved or registered for clinical use only in jurisdictions where the applicable regulatory requirements have been satisfied. </span><span style="color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">Regulatory status may vary by country and is subject to change. </span></p><p> </p><p><span style="color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">Please contact ARPI for the most current information regarding product availability and intended use in your region.</span></p><p> </p><p><span style="font-family:Arial, Helvetica, sans-serif;font-size:18px;">Detailed information on regulatory approvals and registrations by market is provided below.</span></p><p><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;"><strong>European Union (EU)</strong></span></p><ul><li><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">CE Marking under EU MDR (Regulation (EU) 2017/745) — Notified Body: BSI (NB 2797) </span></li><li><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">Classification: Class IIa</span></li></ul><hr><p><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;"><strong>Taiwan </strong></span></p><ul><li><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">TFDA (Taiwan Food and Drug Administration) - Medical Device License </span></li><li><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">Classification: Class II</span></li></ul><hr><p><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;"><strong>Vietnam </strong></span></p><ul><li><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">MOH (Ministry of Health) - Medical Device Registration</span></li><li><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">Classification: Class B</span></li></ul><hr><p><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;"><strong>New Zealand </strong></span></p><ul><li><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">Medsafe - WAND Notification </span></li><li><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">Classification: Class I</span></li></ul><hr><p><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;"><strong>Australia </strong></span></p><ul><li><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">ECG Buddy is entered in the ARTG, (ARTG number: 527556)</span></li><li><span style="background-color:transparent;color:rgb(0,0,0);font-family:Arial, Helvetica, sans-serif;font-size:18px;">Classification: Class IIb </span></li></ul><hr><p><span style="font-family:Arial, Helvetica, sans-serif;font-size:18px;">Please note, clinical use is permitted only in markets where the product has received the necessary regulatory approval or registration.</span></p><p> </p><p><span style="font-family:Arial, Helvetica, sans-serif;font-size:18px;">In countries or regions where regulatory approval has not been obtained, <strong>EB Research is intended exclusively for research and educational purposes and is not intended for clinical diagnosis or patient management.</strong></span></p>
Published: 2026-06-19 Read more 