Registration - Speakers

REGISTRATION DIVISIONS

THE REGISTRATION DIVISION IS RESPONSIBLE FOR ENSURING THAT ALL MEDICAL DEVICES PLACED IN THE MARKET MEET THE REQUIRED REGULATORY STANDARDS FOR SAFETY, QUALITY, AND PERFORMANCE. THE DIVISION PLAYS A VITAL ROLE IN MAINTAINING PUBLIC HEALTH PROTECTION THROUGH A STRUCTURED EVALUATION, VERIFICATION AND APPROVAL PROCESS. IT CONSISTS OF THREE KEY UNITS: THE GENERAL AND IVD REGISTRATION UNIT, THE CHANGE NOTIFICATION UNIT, AND THE CLASSIFICATION AND COMBINATION PRODUCTS UNIT. EACH UNIT PLAYS A VITAL ROLE IN EVALUATING REGISTRATION APPLICATIONS, MANAGING CHANGES TO A REGISTERED MEDICAL DEVICE, AND DETERMINING PRODUCT CLASSIFICATIONS. THE DIVISION SAFEGUARDS THE QUALITY AND SAFETY OF MEDICAL DEVICES THROUGH COMPREHENSIVE EVALUATION PROCESSES. COMPRISING THREE SPECIALIZED UNITS, THE DIVISION ENSURES THAT EVERY MEDICAL DEVICE ENTERING THE MARKET COMPLIES WITH NATIONAL REGULATORY STANDARDS, SUPPORTING PUBLIC HEALTH AND INDUSTRY INNOVATION.