海南省药品监督管理局关于2025年医疗器械质量抽查检验情况的通告

Core Viewpoint - The Hainan Provincial Drug Administration has conducted quality inspections on medical devices in accordance with regulations, with all 110 batches tested meeting the required standards [2]. Group 1: Inspection Overview - A total of 110 batches of medical devices were sampled and tested across various production, operation, and usage stages [2]. - All inspected medical devices were found to be compliant with the established regulations [2]. Group 2: Sampled Medical Devices - The inspection included a variety of products such as electronic thermometers, medical cotton swabs, and disposable syringes, all of which received passing results [2][3]. - Specific products tested include: - Medical electronic thermometer (DT007) from Guangzhou Beierkang Medical Devices, batch number 221200608, passed [2]. - Medical cotton swabs (M40) from Chengdu Xinjing Shifeng Medical Devices, batch number 250211, passed [2]. - Disposable syringes (5ml) from Jiangxi Hongda Medical Devices, batch number 20241207, passed [3]. Group 3: Compliance and Regulatory Framework - The inspections were conducted in accordance with the "Medical Device Supervision and Administration Regulations" and the "Hainan Province 2025 Medical Device Sampling Work Implementation Plan" [2]. - The results of the inspections are intended to enhance the quality supervision of medical devices and ensure public safety [2].

海南省药品监督管理局关于2025年医疗器械质量抽查检验情况的通告 - Reportify