{"id":23875,"date":"2022-12-02T22:48:00","date_gmt":"2022-12-02T14:48:00","guid":{"rendered":"https:\/\/flcube.com\/?p=23875"},"modified":"2025-01-29T22:50:49","modified_gmt":"2025-01-29T14:50:49","slug":"hainans-new-regulations-on-medical-devices-in-boao-lecheng-to-take-effect-in-2023","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=23875","title":{"rendered":"Hainan’s New Regulations on Medical Devices in Boao Lecheng to Take Effect in 2023"},"content":{"rendered":"\n

The \u201cRegulations on the Administration of Medical Devices in Boao Lecheng International Medical Tourism Pilot Zone, Hainan Free Trade Port,\u201d approved by the Standing Committee of Hainan Provincial People’s Congress, is set to take effect as of January 1, 2023. The document is applicable to medical and health services, and development, production, operation, and use of drugs, medical devices, and cosmetics, in the region.<\/p>\n\n\n\n

Regulatory Oversight and Responsibilities<\/strong>
The medical and drug regulatory agencies in the pilot zone are under the purview of Hainan’s provincial health and drug regulatory departments, which are specifically responsible for the supervision and management of medical and health services and drugs, medical devices, and cosmetics in the pilot region. Those agencies are responsible for administrative approvals, administrative punishments, and administrative coercions. The Lecheng pilot is encouraged to support and cultivate new technologies, new formats, and new models of medical drugs and devices, establish an effective communication mechanism, strengthen the publicity of laws and regulations on medical drugs and devices and service guidance, optimize the regulatory process, and promote the high-quality development of the medical drugs and devices industry in the pilot area.<\/p>\n\n\n\n

Clinical Use and Tracing Management<\/strong>
Clinically urgently needed imported drugs and medical devices approved by the provincial people’s government shall only be used by designated medical institutions for specific medical purposes, and shall only be used within the scope of application of the approved imported drug indications and imported medical devices. The area shall establish a tracing management platform for licensed drugs and implement the whole process of data collection, analysis, supervision, and management for the application, procurement, customs clearance, transportation, warehousing, use, and other activities of licensed drugs and equipment.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The \u201cRegulations on the Administration of Medical Devices in Boao Lecheng International Medical Tourism Pilot…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[4],"tags":[91],"class_list":["post-23875","post","type-post","status-publish","format-standard","hentry","category-policy-regulatory","tag-boao-lecheng-pilot-zone"],"yoast_head":"\nHainan's New Regulations on Medical Devices in Boao Lecheng to Take Effect in 2023 - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The \u201cRegulations on the Administration of Medical Devices in Boao Lecheng International Medical Tourism Pilot Zone, Hainan Free Trade Port,\u201d approved by the Standing Committee of Hainan Provincial People's Congress, is set to take effect as of January 1, 2023. 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