Guideline unveiled to strengthen administration of medical devices in Lecheng Pilot Zone

Updated: July 24, 2023 L M S

The 39th session of the 6th Hainan Provincial People's Congress Standing Committee on November 30, 2022 voted to pass a 19-article guideline on strengthening the administration of medicinal products and medical devices in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (the "Pilot Zone"). The guideline came into effect on January 1, 2023.

To integrate supervision of medicinal products and medical devices, the guideline specifies legal status, responsibilities and duties of the medical products administration in the Pilot Zone. The guideline consolidates innovation achievements made by the zone in supervision of medicinal products and medical devices, bolsters the efficiency of collaborative supervision, and resolves chaotic management.

To strengthen management and services governing urgently-needed imported drugs and medical devices (licensed items), the Pilot Zone is entitled to use licensed drugs and medical devices and carry out international cooperation between medical institutions. The guideline fills administrative loopholes, outlines management and service measures, and specifies relevant lawful responsibilities in a drive to strengthen the regulation of operators of medicinal products and medical devices in accordance with laws and rules and promote the healthy development of the medical sector in the Pilot Zone.

To deepen supervision and innovation. To promote reform of streamlining administration and delegating power, enhancing regulation and upgrading government services, bolster and regulate supervision during and after the purchase of medicinal products and medical devices, and build a stable, equitable, transparent and predicable business environment, the guideline adheres to the principle of streamlining administration and delegating power as well as improving services, beefs up regulatory rules, and innovates and enhances collaborative supervision.

To enhance supervision and service levels, the guideline proposes integrating supervision with services and promoting a positive interaction between them to bring more convenience to enterprises and the public. The Pilot Zone shall grant full support to the cultivation of new technologies, business forms and models related to medicinal products and medical devices, build an effective communication mechanism, strengthen legal publicity and service guidance, optimize supervision procedures, and make it possible for government services to be accessed via one website and processed remotely or offline at a single window.