Who Approves Lecheng Special-Access Imports—and Where Can They Be Used?

Lecheng special-access products are not open nationwide. Two State Council decrees set the rules: devices under Guo Fa〔2018〕10, drugs under Guo Fa〔2018〕43. Both give import approval to the Hainan provincial government and lock use to designated institutions for specified medical purposes. That is not a nationwide formulary.

Devices: provincial import approval, designated sites only

On 2 April 2018 the State Council (Guo Fa〔2018〕10) paused Article 11(2) of the Regulations on the Supervision and Administration of Medical Devices inside the Boao Lecheng International Medical Tourism Pilot Zone. For devices that a zone hospital clinically needs and that have no same-type product registered on the Chinese mainland, Hainan provincial government issues the import approval; use is limited to designated institutions. NMPA and Hainan must write implementing rules.

Drugs: small-quantity urgent imports, vaccines excluded

On 21 December 2018 the State Council (Guo Fa〔2018〕43) temporarily adjusted Article 36 of the Implementing Regulations of the Drug Administration Law. Applications by zone hospitals to import a small quantity of clinically urgently needed drugs (excluding vaccines) are approved by Hainan provincial government. Approved drugs must be used inside designated institutions for specified medical purposes, with traceability and adverse-event monitoring.

What an international patient should do

Ask a designated Lecheng hospital in writing whether the product is already approved for import, whether your indication matches, and whether it admits international patients. Prepare passport-identical records, prior therapy, and imaging to the hospital list. Do not travel on the assumption that the product is available nationwide. Limits are set out in the site guide Boao Lecheng special access.

An import approval is not same-day stock, a bed, or a fixed quote. This page restates public decrees; it is not a judgment that a product fits you. Designated site, specified purpose, and traceability follow the license and the hospital’s written reply.