The Standing Committee of the Provincial People's Congress issued the "Regulations on the Administration of Medical Drugs and Equipment in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port"

(Adopted at the 39th meeting of the Standing Committee of the Sixth People's Congress of Hainan Province on November 30, 2022)

Article 1  In order to promote the high-quality development of the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port (hereinafter referred to as the Pilot Zone), standardize the order of medical and health services in the Pilot Zone, ensure the safety and effectiveness of drugs and medical devices, and protect and promote public health, these Regulations are formulated in accordance with the Basic Medical and Health Care and Health Promotion Law of the People's Republic of China, the Drug Administration Law of the People's Republic of China and other relevant laws and regulations, and in combination with the actual situation of the Pilot Zone.

Article 2 These Regulations shall apply to the research, production, operation, use and supervision and management of medical and health services and drugs, medical devices and cosmetics in the Pilot Zone.

Article 3  The medical and drug regulatory agency of the Pilot Zone is an administrative agency of the Pilot Zone jointly stationed by the health and drug supervision and management departments of the Provincial People's Government. It is specifically responsible for the supervision and management of medical and health services and drugs, medical devices and cosmetics (hereinafter referred to as medical drugs and devices) in the Pilot Zone, and exercises corresponding administrative approval, administrative penalties and administrative enforcement powers.

The health and drug supervision and management departments of the Provincial People's Government shall strengthen the overall planning and business guidance of the supervision and management of medical drugs and devices in the Pilot Zone.

The People's Government of Qionghai City and its relevant departments, the management agency of the pilot zone, the customs and other relevant departments shall, in accordance with the division of responsibilities, do a good job in the supervision and management of medical drugs and devices in the pilot zone.

Article 4  The pilot zone shall support and cultivate new technologies, new formats and new models of medical drugs and devices, establish a smooth and effective communication mechanism, strengthen the publicity and service guidance of laws and regulations on medical drugs and devices, optimize the supervision process, and promote the high-quality development of the medical drugs and devices industry in the pilot zone.

Except where otherwise provided by laws and regulations or involving state secrets, the pilot zone shall provide non-face-to-face handling of government service matters through an integrated online government service platform, and implement one-window acceptance and one-network handling of government service matters.

Article 5 The medical and drug regulatory agencies in the pilot zone shall mainly perform the following duties:

(i) Responsible for the registration and approval of medical institutions (excluding Internet hospitals), the approval or filing of large medical equipment configuration of social medical institutions, the approval of radiotherapy and nuclear medicine work, and the approval of foreign medical groups to practice medicine in China for a short period of time;

(ii) Responsible for the supervision and management of the medical institutions and their practitioners in the pilot zone;

(iii) Responsible for the supervision and inspection of public health, drugs, medical devices and cosmetics in the pilot zone;

(iv) Responsible for the collection and disposal of false, untrue and illegal medical and drug device information released in the pilot zone, the publicity of medical and drug device supervision and management laws and regulations, and the handling of medical and drug device emergencies;

(v) Responsible for the acceptance and investigation of complaints and reports related to illegal acts of medical and drug devices in the pilot zone;

(vi) Other duties authorized or entrusted by the health and drug supervision and management departments of the provincial people's government in accordance with the law.

The medical and drug regulatory agencies in the pilot zone shall formulate a list of powers and a list of responsibilities in accordance with the law, and announce them to the public after the consent of the health and drug supervision and management departments of the provincial people's government.

Article 6 Medical institutions carrying out medical cooperation shall file with the medical and drug regulatory authorities of the pilot zone and make it public. The medical and drug regulatory authorities of the pilot zone shall share the filing information with relevant units.

The medical cooperation referred to in the preceding paragraph refers to the medical cooperation activities carried out by medical institutions in the pilot zone in the form of trusteeship, technical cooperation, medical consortium, public hospital franchise, shared hospitals, etc.

Article 7  Clinically urgently needed imported drugs and medical devices (hereinafter referred to as licensed drugs and medical devices) approved by the provincial people's government shall only be used for specific medical purposes in designated medical institutions and limited to the approved indications of imported drugs and the scope of application of imported medical devices.

The pilot zone shall establish a licensed drug and medical device traceability management platform to implement full-process data collection, analysis and supervision and management of the application, procurement, customs clearance, transportation, warehousing, use and other activities of licensed drugs and medical devices.

Designated medical institutions shall strengthen the management of physician prescriptions and the use of licensed drugs and medical devices, establish and implement systems for the transportation and storage of licensed drugs and medical devices, diagnosis and treatment, case tracking and observation, monitoring and reporting of adverse reactions to imported drugs and adverse events of imported medical devices, risk management, traceability management, recall and destruction, and preserve information on diagnosis and treatment activities related to the use of licensed drugs and medical devices.

Designated medical institutions and their staff shall not provide licensed drugs and medical devices to medical institutions or patients that have not been approved for use without authorization.

Article 8 The pilot zone provides full-process services such as import customs, logistics, warehousing and display for licensed drugs and medical devices.

Relevant units involved in the storage and transportation process of licensed drugs and medical devices from warehouses to medical institutions shall sign a written contract to stipulate quality responsibilities, operating procedures and other contents. The relevant certification documents, sales receipts, contracts and annexes of licensed drugs and medical devices shall be retained for reference from the date of signing the contract, and the retention period shall not be less than the period required by relevant national and provincial regulations.

The medical and drug regulatory authorities in the pilot zone shall strengthen supervision and guidance on the provision of warehousing services that meet the storage standards for licensed drugs and medical devices.

Article 9  The pilot zone shall implement a medical drug and device safety risk classification supervision system, implement key supervision on high-risk medical drug and device related activities involving major safety or ethical risks and more complex and difficult activities, and establish a key supervision list.

The pilot zone shall, in accordance with the principle of encouraging innovation and development and ensuring quality and safety, establish and improve an inclusive and prudent supervision mechanism that is compatible with the nature and characteristics of new technologies, new formats and new models of medical drug and device, implement an administrative law enforcement observation period system, and exempt from administrative penalties or administrative compulsory measures for minor illegal acts in medical drug and device related activities that have not yet caused harmful consequences and can be corrected within the administrative law enforcement observation period, and educate, guide and urge the subjects of medical drug and device related activities to consciously abide by the law. The specific measures shall be formulated by the health and drug supervision and administration departments of the provincial people's government in conjunction with the management agency of the pilot zone.

Article 10 The medical and drug regulatory authorities in the pilot zone may take the following measures when conducting supervision and inspection through on-site or off-site inspections:

(i) Conduct random inspections and tests on drugs, medical devices, and cosmetics (excluding licensed drugs and devices) according to the needs of supervision and management;

(ii) Seize and detain drugs, medical devices, cosmetics and related materials that do not meet statutory requirements or have evidence of being harmful to human health;

(iii) Seize places where activities related to drugs, medical devices and cosmetics are conducted in violation of laws, regulations or these provisions;

(iv) Review, copy, seal and detain relevant contracts, bills, account books, electronic data and other materials.

When the medical and drug regulatory authorities in the pilot zone exercise their powers in accordance with the law, relevant units and individuals shall cooperate, provide true and complete documents, records, bills, vouchers, electronic data and other relevant materials in a timely manner in accordance with regulations, answer the questions of the inspectors truthfully, and shall not conceal, refuse or obstruct.

Article 11 The medical and drug regulatory authorities in the pilot zone shall establish a joint supervision and inspection mechanism with the management agency of the pilot zone, the customs, the Qionghai Municipal People's Government and its relevant departments to achieve the sharing and exchange of risk information on medical drugs and devices.

The medical and drug regulatory authorities in the pilot zone may request the assistance and cooperation of the customs, Qionghai Municipal People's Government and its relevant departments when carrying out supervision and inspection work in accordance with the law, and the requested authorities shall provide support according to their duties and powers.

Article 12  If the medical and drug regulatory authorities in the pilot zone believe that the medical and drug device violation cases are major and complex, they may request to be transferred to the health and health or drug supervision and administration departments of the provincial people's government for handling. If the health and health and drug supervision and administration departments of the provincial people's government believe that the medical and drug device violation cases are major and complex, they may also handle them directly. Specific provisions shall be separately formulated by the health and health and drug supervision and administration departments of the provincial people's government.

Article 13 The pilot zone shall use modern information technologies such as the Internet and artificial intelligence to conduct full-process and intelligent supervision and administration of medical and drug device related activities through the medical and drug device supervision information platform of the pilot zone.

The management agency of the pilot zone shall build and maintain the medical and drug device supervision information platform of the pilot zone in accordance with the law, and jointly with the medical and drug regulatory authorities of the pilot zone establish a data security management system for medical and drug devices in the pilot zone.

When carrying out medical and drug device related activities in the pilot zone, the medical and drug device supervision information platform of the pilot zone shall be connected, and the authenticity and integrity of the uploaded data shall be guaranteed.

Data collected through the medical drug and device supervision information platform of the pilot zone, after being reviewed by the medical drug regulatory agency of the pilot zone and meeting the requirements of authenticity, clarity, completeness and accuracy, can be used as evidence for the implementation of administrative penalties and administrative enforcement.

Article 14  The management agency of the pilot zone shall, together with the relevant departments of the provincial people's government, establish a medical drug and device credit management mechanism in the pilot zone, strengthen the credit information security management, and strengthen the application of credit commitments in administrative licensing, supervision and management, and credit evaluation.

The medical drug regulatory agency of the pilot zone shall establish medical drug and device credit records based on the medical drug and device supervision information platform, carry out credit evaluation, implement graded and classified supervision, and implement trustworthy incentive measures such as giving priority to handling and reducing the proportion of spot checks and dishonest punishment measures such as not applying the credit commitment system and listing as key supervision targets in accordance with the law with the management agency of the pilot zone.

Article 15  If a medical cooperation is not filed as required in accordance with Article 6 of these Regulations, the medical drug regulatory agency of the pilot zone shall order it to make corrections within a time limit; if it fails to make corrections within the time limit, it shall be given a warning and fined not more than 30,000 yuan; if the circumstances are serious or cause serious consequences, it shall be ordered to stop practicing.

Article 16  Any person who violates Article 7 of these Regulations and uses imported drugs beyond the indications or the scope of application of imported medical devices shall be ordered to make corrections by the medical drug regulatory agency of the Pioneer Zone; if a medical accident or other serious consequences are caused, penalties shall be imposed in accordance with relevant laws and regulations.

Any person who violates Article 7 of these Regulations and provides licensed drugs or medical devices to medical institutions or patients that have not been approved for use without authorization shall have his illegal gains confiscated and be fined not less than 15 times but not more than 30 times the value of the licensed drugs and medical devices illegally transferred.

Article 17  Any person who violates Article 8 of these Regulations and fails to retain relevant information in accordance with the regulations shall be ordered by the medical drug regulatory agency of the Pioneer Zone to make corrections within a time limit and be given a warning; if the correction is not made within the time limit, a fine of not less than RMB 10,000 but not more than RMB 50,000 shall be imposed.

Article 18 For acts that violate these Regulations, if these Regulations do not set penalties, and other laws and regulations have other provisions, they shall be followed.

Article 19 These Regulations shall come into force on January 1, 2023.