DMAH Operations
Product Examples That We Act as a DMAH
・ECG monitor (USA)– ClassⅡ
・Multiparameter Monitor (China)– ClassⅡ
・Diagnostic Ultrasound Imaging (China) – ClassⅡ
・Electronic Stethoscope (Korea) – ClassⅡ
・Dental implant system (Korea) – Class III
・Single-use injection needle (Korea) – Class II
・Single-use infusion/drainage blunt needle (Korea) – Class II
・Radioactive compound synthesizing facilities (Belgium) – Class III
・Dental implant abutment (Korea) – Class III
・Dental synthetic resins for crown and bridge (Korea) – Class II
・Flexible video cystoscope (Denmark) – Class II
・Evacuated sealed blood collecting tube (Taiwan) – Class II
・Acrylic denture base resins (Korea) – Class II
・Drug/vaccine injection needle (China) – Class II
・Dental porcelain for machinable ceramic block (Korea) – Class II
・Total hip prosthesis (Korea) – Class III
・Dental implant suprastructure (Korea) – Class II
・Healing promoting material using human amnion (USA) – Class Ⅳ
・Vesicoureteral reflux treatment injectable material (USA) – Class III
・Single-use endoscopic injection needle (USA) – Class II
Manufacturing operation
・Quality Inspection
・Labeling (Legal indication), Attaching of the “Package Insert”
・Shipment
・Inventory management
・Order management
Regulatory Document Preparation
Regulatory applications are supported by our parent company EXPARTNER JAPAN Co.,Ltd.