博鳌乐城的患者如何使用已在国外获批但尚未在中国获批的药品和器械？
根据国务院 2018 年的决定，海南省政府可以批准为博鳌乐城先行区内的指定医院进口临床急需的药品和器械。药品必须已在国外获批、未在中国注册，且国内没有替代产品（疫苗除外）。药品仅可在申请医院、为特定用途、经知情同意后使用。部分口服药可在限定数量内带出先行区。
**Legal basis.** In April 2018 the State Council suspended part of the Medical Device Supervision Regulations in the zone so Hainan can approve urgently needed devices with no registered equivalent in China (Guo Fa [2018] No. 10). In December 2018 it allowed Hainan to approve small imports of urgently needed drugs, excluding vaccines, for designated institutions. **Current rules (in force since May 1, 2023, Qiong Fu [2023] No. 16).** - Drug: approved abroad, not registered in China, and no Chinese-approved product can replace it. Device: approved abroad with no same-type product registered in China. - Only designated hospitals with Grade III Class A level capability and adverse event monitoring may apply. - The provincial health commission gives an opinion within 5 working days; the provincial drug regulator decides within 7 working days. - The hospital must tell the patient the product was imported under this pathway and get signed informed consent. - Patients may take home a reasonable, self-use quantity when the hospital judges it safe. - Once a product is registered in China, it is no longer imported this way. - Real-world data from these uses can support a Chinese registration application. **Scale.** The Hainan government reports over 470 such products imported by April 2025. Eligible imports are exempt from import tariffs and VAT under a 2024 central government circular. **What this means for you.** Access depends on a designated hospital applying for a specific product and judging you clinically eligible. Prices are set by hospitals and are not covered by Chinese basic insurance. Ask the hospital for the product's approval status and full cost in writing before travel.
信息来源
- Drug import management changed in Hainan medical tourism pilot zone
“Such imported drugs should be used in the designated medical institutions for a specified purpose, the circular stated.”
- 海南自由贸易港博鳌乐城国际医疗旅游先行区临床急需进口药品医疗器械管理规定 (Qiong Fu [2023] No. 16)
“本规定中的临床急需进口药品，是指先行区医疗机构因临床急需，进口已在境外批准上市，未获我国批准注册、国内已上市品种无法替代的药品(不包括疫苗)。”
- Boao Lecheng International Medical Tourism Pilot Zone
“As of April 2025, Lecheng has imported over 470 innovative medicines and devices not yet approved on the mainland, benefiting more than 110,000 patient visits, an annual increase of 134.2 percent over the past five years.”
- Hainan's special health zone pulls in more patients
“The first public hospital in the pilot zone, the Ruijin-Hainan Hospital affiliated to Shanghai Jiao Tong University School of Medicine opened for trial operations in December, 2021.”
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