Hainan Provincial Health Commission 

Notice on Issuing the Guidelines of the Hainan Boao Lecheng International Medical Tourism Pilot Zone for Medical Institutions on Qualification Assessment Application to Use Imported Drugs and Medical Devices in Urgent Clinical Need

All relevant medical institutions in the Hainan Boao Lecheng International Medical Tourism Pilot Zone,

In accordance with the relevant rules, such as the Regulations of the Hainan Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port on the Administration of Drugs and Medical Devices (Announcement No. 132 of the Standing Committee of Hainan Provincial People’s Congress), the Notice on Issuing 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 (Q.F. [2023] No. 16) issued by the People’s Government of Hainan Province, and the 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 (Q.W.G. [2024] No. 4) issued by the Hainan Provincial Health Commission (the “Commission”), the Commission has formulated the Guidelines of the Hainan Boao Lecheng International Medical Tourism Pilot Zone for Medical Institutions on Qualification Assessment Application to Use Imported Drugs and Medical Devices in Urgent Clinical Need (“Guidelines”). These Guidelines are hereby issued for your compliance.

                                      Hainan Provincial Health Commission

                                                  June 13, 2024

Guidelines of the Hainan Boao Lecheng International Medical Tourism Pilot Zone for Medical Institutions on Qualification Assessment Application to Use Imported Drugs and Medical Devices in Urgent Clinical Need

I. Matter

Application by Medical Institutions for Qualification Assessment for Using Imported Drugs and Medical Devices in Urgent Clinical Need.

II. Applicants

Medical institutions within the Hainan Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port.

III. Legal Basis

i. Regulations of the Hainan Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port on the Administration of Drugs and Medical Devices (Announcement No. 132 of the Standing Committee of Hainan Provincial People’s Congress);

ii. Notice on Issuing 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 (Q.F. [2023] No. 16) issued by the People’s Government of Hainan Province;

iii. 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 (Q.W.G. [2024] No. 4) issued by the Hainan Provincial Health Commission.

IV. Application Requirements

i. The applicant has obtained the Practicing License for a Medical Institution in accordance with the law, has the capabilities of a Grade A tertiary hospital, and has specialized departments that require using the imported drugs and medical devices in urgent clinical need as requested;

ii. The applicant has distribution, transportation, and storage safeguards and management systems in compliance with the nature of the imported drugs and medical devices in urgent clinical need and the requirements stated in the specifications;

iii. The applicant has established a monitoring institution for adverse reactions/events in drugs and medical devices, and the institution is staffed by dedicated and well-trained personnel who can properly perform their duties to monitor adverse reactions/events;

iv. The applicant has contingency plans and response capabilities against possible serious adverse reactions/events in imported drugs and medical devices in urgent clinical need.

V. Application Materials

i. Qualification Assessment Application Form for Departments of Medical Institutions in the Hainan Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port to Use Imported Drugs and Medical Devices in Urgent Clinical Need (refer to the attachment);

ii. Staff and facility/equipment information (including the staff list, professional titles, training content, training certificates, and facility/equipment lists);

1. Staff list/professional titles:

Practice information such as specialties of doctors in the department and team, their professional titles and specialties, main practice/multi-institution practice, relevant practice certificates of auxiliary staff, and profiles of clinical experts.

2. Training content and certificates:

Training on policies on licensed drugs and medical devices and the medical institution’s internal management systems for licensed drugs and medical devices;

Training provided by the manufacturers to the team and related doctors before they use the licensed drugs and medical devices, as well as the training certificates; (if any)

First-aid training of the department/medical institution (required), as well as first-aid-related training certificates (if any);

Qualifications obtained by the team and related physicians as recognition of their domestically leading capabilities, such as those issued by academic forums and training activities or proving their participation in drafting expert consensus/clinical practice guidelines; (if any)

(training materials such as training plans, notifications, sign-in records, photos, and assessment results shall be provided.)

3. Facility/equipment list:

First-aid and rescue facilities/equipment within the department;

Basic conditions of the treatment rooms required for the treatments conducted;

If surgery is involved, the basic conditions and facilities required for conducting the surgery, including the main facilities/equipment within the surgical room and staffing information.

iii. Related systems (systems on the use and management of licensed drugs and medical devices):

Mainly the systems on the use and management of licensed drugs and medical devices, including but not limited to the following:

Pharmacy management: Including management systems for the procurement, acceptance, storage, distribution, shelf life, returns, maintenance, calibration, scrapping and disposal, recall, traceability management, and adverse reaction monitoring of licensed drugs and medical devices;

Medical administration: Including systems for the admission management of new technologies for licensed drugs and medical devices, classified management and authorization of surgery, using doctor re-authorization regarding licensed drugs and medical devices, the management working group and management measures of the institution using licensed drugs and medical devices, integration and establishment of first-aid support systems for licensed drugs and medical devices, and efficacy evaluation of licensed drugs and medical devices.

Off-site medical use management: Including systems for off-site use, archive management of the off-site use traceability platform, and misuse prevention for licensed drugs and medical devices used off-site.

Follow-up management: Including management systems for follow-up visits regarding licensed drugs and medical devices, specific procedures and requirements for follow-up visits, and emergency response management measures for follow-up visits.

iv. Information on the adverse reaction/event monitoring institution (including institution establishment, staffing, staff qualifications, and relevant systems);

1. Adverse event management group and its duties (including the appointment of adverse reaction monitoring staff and the definition of their duties);

2. Procedures for handling adverse reactions arising from licensed drugs and medical devices;

3. Monitoring and reporting system for adverse reactions arising from licensed drugs and medical devices;

4. Other relevant systems.

v. Contingency plan (establishment of an emergency management organization and related systems regarding the use of licensed drugs and medical devices, relevant plans, and drills).

1. Structure of the emergency management organization for licensed drugs and medical devices;

2. Detailed contingency plan for licensed drugs and medical devices (including the person in charge of each process and his/her duties);

3. Records of contingency plan drills (including scripts, participants, photos of on-site drills, identified issues, and improvement plans);

4. If a medical institution lacks corresponding first-aid capabilities, it shall execute a first-aid agreement with a capable medical institution and enhance first-aid training.

VI. Review Procedures

Acceptance - review and assessment - (special process) - approval

VII. Processing Duration

Ten business days.

Attachment: Qualification Assessment Application Form for Medical Institutions in the Hainan Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port to Use Imported Drugs and Medical Devices in Urgent Clinical Need