To further optimize the business environment in Hainan Boao Lecheng pilot zone of international medical tourism (the Pilot Zone), simplify the approval process of imported drugs and medical devices in urgent clinical need, optimize the approval mode, improve the effectiveness of regulatory services, facilitate the public to timely use imported drugs and medical devices in urgent clinical need, the Several Measures to Further Optimization of Regulatory Services to Support the High-Quality Development of Hainan Boao Lecheng Pilot Zone of International Medical Tourism (the Measures) was issued by Hainan Provincial Drug Administration and related bodies.
Major Measures Related to the Overseas Manufacturers
I.Hainan Provincial Drug Administration and Haikou Customs shall handle clearance procedures for imported drugs and medical devices in urgent clinical need in accordance with the provisions and support electronic customs clearance of imported drugs and medical devices in urgent clinical need. Designated medical institutions and entrusted enterprises shall not import refurbished medical devices or transfer medical devices in use from foreign medical institutions. It is forbidden to import expired, invalid, obsolete and used medical devices.
II.Imported drugs in urgent clinical need are not subject to import inspection. Medical devices and items included in the “Correspondence Table of Customs Commodity Codes and Inspection and Quarantine Names for Special Items” shall be subject to administrative licensing in accordance with relevant customs regulations.
III.For imported drugs and medical devices in urgent clinical need with inconsistent management properties inside and outside the country, it is managed according to the properties approved outside the country.
IV.The imported drugs and medical devices in urgent clinical need approved for use is treated as a variety that has been approved for import registration in Lecheng pilot zone and is allowed to receive charitable donations and is managed according to the imported drugs and medical devices in urgent clinical need.
V.After the imported drugs and medical devices in urgent clinical need is approved for marketing in China, if there are unapproved indications, the product can be applied for use as imported drugs and medical devices in urgent clinical need only for unapproved indications.
VI.Hainan Provincial Drug Administration in conjunction with the Lecheng pilot zone management department to establish a licensed drugs and devices traceability management platform to achieve the application, procurement, import, distribution, use, adverse reaction monitoring and other whole-process traceability management of the imported drugs and medical devices in urgent clinical need.
Introduction to the Pilot Zone
On February 28, 2013, the Pilot Zone was established with the approval of the State Council of China. The Pilot Zone develops international medical tourism related industries such as licensed medical treatment, health management, care and rehabilitation, medical beauty and anti-aging, aiming to gather international high-end medical tourism services and international cutting-edge medical scientific and technological achievements, and create an international medical technology service industry cluster.
At present, a total of 130 kinds of innovative drugs and medical devices not listed in China are used in the Pilot Zone. “The Pilot Zone can provide patients with many ‘Lecheng schemes’. When they use these international innovative drugs and medical devices, more hope can be brought to their lives. In a sense, Lecheng can be called a hope city.” said Yan Lukai, director of the Publicity Department of Lecheng Pilot Zone Management Bureau.
Beneficial Policies of the Pilot Zone
According to the pilot policy endowed by the state, the Pilot Zone is the only area in mainland China that can use international innovative drugs and medical devices that have been listed abroad but not in China currently.
RWD
In September 2019, the state further supported the development of the Pilot Zone, and clearly proposed to carry out real-world data (RWD) application research. In more than a year after that, RWD research in the Pilot Zone has promoted the listing of three innovative pharmaceutical equipment products in China, including two medical devices and one drug. This undoubtedly provides a high-speed channel for international innovative medical devices to accelerate their entry into the Chinese market.
As a professional consulting company, we have helped many of our clients in the application by using these beneficial policies. If you are not sure whether this is applicable to your product, please contact us (info@inspirativemed.com) and our seasoned staff can help you with the assessment.
