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

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.

The guideline notes that the medical products administration is a government department authorized by the Hainan Provincial Health Commission and Hainan Medical Products Administration to fulfill the duties of supervising medicinal products and medical devices, and exercising the corresponding authorities of administrative permission, punishment and coercion.

The guideline introduces a list of well-defined government powers and a list of responsibilities of the medical products administration in the Pilot Zone, and outlines available measures and relevant systems of regulatory enforcement.

According to the guideline, the Hainan Provincial Health Commission and the Hainan Medical Products Administration shall strengthen their coordination and guidance for the supervision of medicinal products and medical devices in the Pilot Zone. The guideline also specifies the main responsibilities of the Qionghai Municipal People's Government and its relevant departments, the administration of the Pilot Zone, the Customs, and other relevant departments.

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.

The guideline proposes strengthening whole-process supervision and services for licensed drugs and medical devices. Licensed drugs and medical devices can only be used by designated medical institutions for special medical purposes in line with declared functions of imported drugs and the application scope of imported medical devices. Data collection, analyses and supervision shall be adopted to regulate the application, purchase, customs clearance, transportation, storage and utilization of licensed drugs and medical devices. Designated medical institutions shall strengthen their supervision of doctors' prescriptions and the use of licensed drugs and medical devices, and set up and implement a set of systems related to the transportation and storage of licensed drugs and medical devices, making diagnosis and treatment decisions, follow-up observations of case studies, monitoring and report of negative reactions and incidents caused by imported drugs and medical devices, risk response, tracing management, recall and product destruction. The Pilot Zone shall provide operators of licensed drugs and medical devices with import clearance, logistics, storage and exhibition services. In addition, the guideline specifies supervision of storage services and relevant procedures connected with licensed drugs and medical devices.

The guideline also underlines the scope of international cooperation between medical institutions. Medical enterprises must report to medical products administrations in the Pilot Zone about their tentative international cooperation and make relevant activities known to the public.

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.

The guideline proposes categorized supervision, with medical products that bear foremost importance to public safety, lead to potential ethical questions, or are complicated and difficult to manage made the key targets of supervision. It also calls for sufficient space and a good environment for the development of new technologies, business forms, and models associated with medicinal products and medical devices even with stepped-up supervision. Inclusive and cautious supervision mechanisms are to be established and improved in accordance with the nature and features of new technologies, new business forms and new models related to medicinal products and medical devices. An observatory period is expected for regulatory enforcement. The guideline also specifies circumstances under which administrative punishment and compulsory measures will not be imposed.

The guideline proposes intelligent supervision. An information platform for the supervision of medicinal products and medical devices should be established to make supervision activities more precise and intelligent. Whole-process and intelligent supervision and management will be adopted for medicinal products and medical devices. Supervision data shall be used in accordance with the law. With the approval of medical products administration in the Pilot Zone, relevant data can be applied to administrative punishment and compulsory actions against unlawful behavior.

The guideline proposes credit-based supervision. A credit system for the utilization of medicinal products and medical devices will be set up to bolster supervision efficiency, promote credit assessment and conduct categorized supervision. Incentive measures such as preferential services and lowered inspection percentages will be given to those enterprises which score high in credit ranking. Punishment against bad-faith acts will be enforced in accordance with laws and regulations.

The guideline proposes joint supervision. A cross-department law enforcement response and collaboration mechanism shall be established to improve traditional supervision methods and solve divisions of governance. Medical products administration in the Pilot Zone should work with the local administrative commission and the customs agency, as well as the Qionghai Municipal People's Government and other competent departments to set up joint supervision and inspection mechanisms to ensure the sharing of risk information related to medicinal products and medical devices.

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.