我省又一自主研制的第三类医疗器械产品获批上市

Core Viewpoint - Hainan Xirida Biotechnology Co., Ltd. has received approval from the National Medical Products Administration for its Class III medical device, "Sodium Hyaluronate Injection Solution," marking the first such product approved for medical aesthetics in Hainan Province, filling a gap in the local market [1] Company Overview - Hainan Xirida Biotechnology Co., Ltd. was established in 2014 and operates in dermatology, gynecology, pediatrics, and medical devices, functioning as a comprehensive enterprise involved in research, development, production, and sales [1] Product Details - The approved product consists of a pre-filled glass syringe containing sodium hyaluronate solution, which includes non-crosslinked sodium hyaluronate, sodium chloride, disodium hydrogen phosphate, dipotassium hydrogen phosphate, and sterile water for injection [1] - The product is intended for use in medical institutions for superficial dermal injections to temporarily improve issues such as skin dryness and dull complexion in adults [1] Industry Context - Hainan Province has seen a rapid increase in the approval of Class III medical devices, with a total of 30 products approved to date, and the average number of approvals doubling each year over the past three years [1]