进口平均审批时限压缩至1.6天，“中国首用”药械达523种

Core Insights - The average approval time for imported medical devices and drugs in the Hainan Boao Lecheng International Medical Tourism Pilot Zone has been reduced to 1.6 days, facilitating faster access to international innovations for patients in China [1][2] - The Lecheng Pilot Zone has successfully introduced 523 types of international innovative medical devices and drugs, benefiting over 180,000 patients, and aims to further enhance its medical technology and drug importation efforts [2][3] Group 1 - The first global hormone replacement therapy drug for hypoparathyroidism, parathyroid hormone replacement therapy, has been successfully used by a patient in Hainan, despite not being officially launched in mainland China [2] - The Lecheng Pilot Zone's unique policies, including "licensed medical devices" and "real-world research," have enabled a significant reduction in the approval process for new medical products [2][3] - The introduction of a "zero tariff" policy for imported medical devices and drugs has further streamlined the process, reducing the average approval time from 5 working days to 1 working day [2] Group 2 - The ongoing China International Import Expo has attracted over 30 renowned domestic and international pharmaceutical and medical device companies, indicating strong interest in the Lecheng Pilot Zone [3] - The Lecheng Pilot Zone has established deep cooperative relationships with over 180 pharmaceutical and medical device companies from 20 countries and regions, including many of the top 30 global firms [3] - The management of the Lecheng Pilot Zone plans to refine the tax-exempt catalog for medical devices and drugs, aiming to create a world-class international medical tourism destination and a medical innovation platform [3]