海南又一款第三类医疗器械获批上市

Core Insights - A new Class III medical device, "absorbable surgical suture," developed by Hainan Baimaike Medical Technology Co., Ltd., has been approved for market release by the National Medical Products Administration (NMPA) [1] - This approval marks the seventh Class III medical device approved in Hainan this year, contributing to a total of 28 approved devices in the province [1] - The average annual approval rate for Class III medical devices in Hainan has doubled over the past three years [1] Industry Developments - The absorbable surgical suture is made from a copolymer material consisting of 75% glycolide and 25% caprolactone, designed for soft tissue suturing [1] - The provincial drug regulatory authority has implemented measures to support the research and registration of Class III medical devices, providing focused guidance and full tracking services [1] - Hainan has two batches of five products included in the NMPA's priority review pilot program, accounting for approximately 10% of the national total [1]