Per the official release of the FTP Pharmaceuticals & Medical Devices Declaration Guide as publicized at the recent "Administrative Measures for the 'Zero Tariff' Import of Pharmaceuticals and Medical Devices in the Hainan Free Trade Port” press conference, importers, institutions, and other eligible organizations can now submit their applications for zero-tariff import.

There are two types of pharmaceuticals and medical devices that are eligible for the Hainan Free Trade Port “zero tariff” policy: imported pharmaceuticals and medical devices that have been approved for registration in China; or—according to the relevant provisions of the State Council—pharmaceuticals (excluding vaccines) and medical devices that have not yet been approved for registration in China but are approved by the Hainan Provincial People's Government to be imported and used in Hope City (also known as "specially approved pharmaceuticals and medical devices").

Prior to special customs operation of the whole island, medical institutions, medical colleges and universities, and pharmaceutical research institutes registered in the Boao Lecheng (Hope City) International Medical Tourism Pilot Zone can be exempted from import tariffs and import stage value-added taxes if they import any of the drugs or medical devices specified.

Hope City is one of the FTP's key industrial parks (Photo: Meng Zhongde)

To ensure the smooth implementation of the FTP’s "zero tariff" policies for pharmaceuticals and medical devices, the Hainan Provincial Medical Products Administration has formulated and promulgated a Pharmaceuticals & Medical Devices “Zero-tariff” Declaration Guide.

The Guide clarifies key content such as “who can apply,” “the conditions for application,” “the required materials,” "the review process,” and “the time limit for making an application.” By filling in the "Basic Information Form for Application for Import of ‘Zero Tariff’ Pharmaceuticals (or Medical Devices)," eligible beneficiaries can apply on the Medical Products Administration’s online management platform. If the pharmaceutical or medical device in question has been approved for registration in China, they will also need to submit a scanned copy of the imported product’s registration approval documents. The Provincial Medical Products Administration and Boao Lecheng (Hope City) International Medical Tourism Pilot Zone Administrative Bureau will complete the review within five working days, and forward on to the relevant customs and taxation departments any applications which comply with the necessary requirements.

To further enhance service efficiency, the Provincial Medical Products Administration has both strengthened their data sharing mechanism and simplified the application requirements. When filling out the aforementioned "Basic Information Form,” applicants for "specially approved pharmaceuticals and medical devices” need only to fill in their item’s related document number. By removing the requirement to resubmit the documentation for a previously approved item, the application process is sped up considerably.

At the same time, Customs also implements—in accordance with the law—a three year supervision period of all imported pharmaceuticals and medical devices that enjoy "zero tariff" policies.