Hainan Provincial Health Commission

Notice on Issuing the Management Measures of the Hainan Boao Lecheng International Medical Tourism Pilot Zone for Qualification Assessment and Supervision of Departments Using Imported Drugs and Medical Devices in Urgent Clinical Need

All medical institutions in the Hainan Boao Lecheng International Medical Tourism Pilot Zone and the Lecheng Medical Products Administration,

In order to further regulate the qualification application and assessment procedures for departments using imported drugs and medical devices in urgent clinical need, enhance whole-process supervision and management, and ensure the safe use of licensed drugs and medical devices, the Hainan Provincial Health Commission has formulated the Management Measures of the Hainan Boao Lecheng International Medical Tourism Pilot Zone for Qualification Assessment and Supervision of Departments Using Imported Drugs and Medical Devices in Urgent Clinical Need (“Measures”) in accordance with the Regulations of the Hainan Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port on the Administration of Imported Drugs and Medical Devices in Urgent Clinical Need. These Measures are hereby issued for your compliance.

Hainan Provincial Health Commission

                                May 18, 2024

Management Measures of the Hainan Boao Lecheng International Medical Tourism Pilot Zone for Qualification Assessment and Supervision of Departments Using Imported Drugs and Medical Devices in Urgent Clinical Need

Article 1 In order to further regulate the qualification application and assessment procedures for departments of medical institutions in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (“Lecheng Pilot Zone”) using imported drugs and medical devices in urgent clinical need (“Licensed Drugs and Medical Devices”), enhance whole-process supervision and management, promote the continuous compliance of departments at designated medical institutions with the stipulated conditions and capabilities, and ensure the safety use of Licensed Drugs and Medical Devices, these measures (“Measures”) are formulated in accordance with the Regulations of the Hainan Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port on the Administration of Imported Drugs and Medical Devices in Urgent Clinical Need (“Regulations”).

Article 2 Medical institutions or departments applying for the qualifications to use Licensed Drugs and Medical Devices shall meet the conditions stipulated in Article 6 of the Regulations.

Article 3 Medical institutions in compliance with the qualification application requirements shall apply according to the following procedures:

1. A medical institution can apply to the Lecheng Medical Products Administration for a capability assessment of the department(s) using Licensed Drugs and Medical Devices based on their capabilities.

2. The Lecheng Medical Products Administration shall review the application materials submitted by the medical institution. If the materials meet the requirements, the application will be accepted; otherwise, a written notice of rejection will be issued.

3. The Lecheng Medical Products Administration shall review and assess the accepted application materials. If special processes such as on-site verification and assessment are deemed necessary, the applicant shall be notified. Special processes are not included in the review time. If the content review and the special process review and assessment meet the requirements, a written assessment opinion shall be issued by the Lecheng Medical Products Administration and submitted to the Hainan Provincial Health Commission for filing; otherwise, the Lecheng Medical Products Administration shall issue a written notice of rejection to the applicant.

Article 4 The Lecheng Medical Products Administration shall decide whether to grant the qualification to use Licensed Drugs and Medical Devices to the applicant and relevant departments within ten business days of accepting the application.

Article 5 An exit management mechanism for the qualifications of departments using Licensed Drugs and Medical Devices shall be implemented. Medical institutions in the Lecheng Pilot Zone shall assume the entity responsibility for whether they can continuously meet the qualification requirements for departments using Licensed Drugs and Medical Devices. They shall enhance their respective capabilities to ensure the safe use of Licensed Drugs and Medical Devices. If a medical institution no longer possesses the corresponding capabilities, it shall proactively apply for suspension or cancellation of its qualifications.

Article 6 A centralized supervision and management mechanism for the qualifications of departments using Licensed Drugs and Medical Devices shall be implemented. The Lecheng Medical Products Administration shall organize a centralized inspection of medical institutions and departments approved to use Licensed Drugs and Medical Devices every three years and randomly inspect at least one-third of the departments each year. For those found to no longer meet the use conditions or have the designated capabilities or to have not conducted business related to the Licensed Drugs and Medical Devices within two years, their qualifications shall be suspended or canceled. Medical institutions and departments whose qualifications are canceled shall file a new application for qualifications if they need to use Licensed Drugs and Medical Devices again.

Article 7 If relevant authorities find a medical institution or a department to no longer possess the appropriate capabilities during the medical institution verification, supervisory inspection of medical quality, or any other inspection, or if a medical institution or a department is in a circumstance stipulated in the Regulations that will cause its qualification to be suspended or canceled, they shall, in accordance with relevant laws and regulations, suspend or cancel the medical institution’s or the department’s qualifications to use Licensed Drugs and Medical Devices. The medical institution or department that has had its qualifications suspended or canceled shall not continue using or shall not apply for Licensed Drugs and Medical Devices until its qualifications are restored or granted again.

Article 8 Medical institutions and departments that have had their qualifications suspended or canceled shall strengthen risk self-assessment and actively remedy issues until they meet the stipulated conditions and have the required capabilities again. Those with their qualifications suspended shall, upon completing remediation, submit a new application to the Lecheng Medical Products Administration for an acceptance inspection. If they pass the inspection, their qualifications will be restored. Those with their qualifications canceled shall not apply for the qualifications again until six months later, and the acceptance inspection results shall be reported to the Hainan Provincial Health Commission for filing.

Article 9 The Lecheng Pilot Zone Administration shall support the incorporation of the whole-process supervision and management of the qualifications of departments using Licensed Drugs and Medical Devices into the Lecheng Pilot Zone’s traceability management platform for Licensed Drugs and Medical Devices. This enables information technology-empowered management of the department qualifications throughout the process, from application, acceptance, and review, to regulation. Separate approval documents will not be issued for decisions made in the traceability system regarding granting, suspending, and canceling the qualifications.

Article 10 The detailed guidelines for departments on applying for qualifications to use Licensed Drugs and Medical Devices (including procedures for qualification suspension and cancellation) shall be separately developed by the Hainan Provincial Health Commission.

Article 11 These Measures shall be effective as of the date of issuance.