Notice of the Hainan Provincial Health Commission on Further Strengthening the Management of Restrictive Medical Technologies

To the health commissions of all cities and counties; all affiliated hospitals of Hainan Medical University; all medical institutions directly under the commission; all socially-run medical institutions; the Hainan Medical Academic Exchange Management Center; and the commission's Medical Management Service Guidance Center:

In order to further strengthen the clinical application management for medical technologies in Hainan, to ensure the quality and safety of medical care, and to maintain the health rights and interests of the people,  we hereby outline the requirements for further enhancing the management of restrictive medical technologies in the province, in accordance with the Administrative Measures for Clinical Application of Medical Technologies, the Notice from the General Office of the National Health Commission on Issuing the National Catalog of Restrictive Technologies and Clinical Application Management Standards (2022 Edition), and the Notice on the Implementation Details of the Administrative Measures for Clinical Application of Medical Technologies in Hainan Province.

First, based on the actual situation across the province and the national catalog of restrictive technologies (2022 edition), 25 types of technologies, including vascular intervention and endoscopy, are listed in the first batch of the provincial catalog of restrictive medical technologies. Ongoing and ex-post oversight shall be strengthened in accordance with the related requirements of the Notice on the Implementation Details of the Administrative Measures for Clinical Application of Medical Technologies in Hainan Province.

Second, medical institutions planning to carry out clinical applications of "restrictive medical technologies" should conduct self-assessments in accordance with relevant management standards. Those meeting the standards may apply the technologies and must register with the Hainan Medical Academic Exchange Management Center within 15 working days from the date of the first clinical application.

Third, for a medical institution that has been assessed as meeting the requirements, it should registered with the related health administrative department once obtaining its "Medical Institution License" and update the relevant information in the electronic registration system of medical institutions.

Fourth, from the date when this notice was issued, medical institutions that have already carried out "restrictive medical technologies" should immediately apply for registration with the Hainan Medical Academic Exchange Management Center. Failure to register as required will result in penalties by the health administrative departments in accordance with the relevant provisions of the Regulations on the Management of Medical Institutions.

Fifth, medical institutions should provide transparent information about the catalog of restrictive medical technologies and their related clinical application progress, and be supervised by the public. The information should include the technology’s name, date of registration, the number of application cases, as well as its quality and safety.

Sixth, efforts should be made to evaluate standardized training centers for the clinical application of restrictive medical technologies in the province. Medical institutions meeting the requirements will be registered and conduct related training.

Seventh, efforts should be made to strengthen the standardized training for medical personnel in the clinical application of medical technologies. Doctors utilizing restrictive technologies must undergo standardized training and pass the assessment, according to the relevant standards.

Hainan Provincial Health Commission

May 15, 2023