Core Viewpoint - The Xinjiang Shawan City Market Supervision Bureau is conducting a special inspection action focused on the quality and safety of medical devices, particularly those commonly used by the elderly, in conjunction with the upcoming Chongyang Festival [1] Group 1: Inspection Focus - The inspection targets medical devices frequently used by the elderly, including blood glucose meters, blood pressure monitors, wheelchairs, walking aids, and medical patches [1] - Key locations for the inspections include pharmacies, medical device businesses, and medical institutions within the jurisdiction [1] Group 2: Regulatory Actions - Enforcement personnel are rigorously checking product registration certificates, qualifications, purchase inspection records, and product labels to identify illegal activities such as unlicensed operations, sale of expired products, and false advertising [1] - The Market Supervision Bureau aims to strengthen the regulation of the entire medical device supply chain and combat illegal activities while eliminating safety hazards [1] Group 3: Public Awareness and Reporting - The bureau encourages citizens to enhance their awareness of safe medical device usage and to report any problematic medical devices through the 12315 hotline [1] - The initiative aims to build a stronger safety defense for medical devices, ensuring better health protection during the Chongyang Festival [1]

Core Viewpoint - The rise of decorative contact lenses, commonly known as "colored contacts," in the Hong Kong market has raised safety concerns due to the prevalence of low-quality parallel-imported products, prompting calls for regulatory measures [1][3]. Regulatory Environment - The Hong Kong Optometrists Association highlighted the absence of a medical device regulatory framework in Hong Kong, contrasting it with other regions that have established comprehensive regulations for consumer medical devices, including contact lenses [3][6]. - The association proposed the establishment of a mandatory registration system for consumer medical devices and restrictions on the online sales of unregistered products to mitigate health risks [1][3]. Public Awareness and Perception - A survey conducted by the association revealed that over 81% of respondents perceive "parallel-imported" products as unsafe, yet only about 26% feel capable of distinguishing these products [3][6]. - Approximately 40.9% of respondents support the idea of mandatory registration for all consumer medical devices, indicating a significant public interest in regulatory measures [3]. Health Risks and Recommendations - Eye care professionals emphasized that contact lenses, including decorative types, are medical devices that require professional fitting to avoid serious health issues, such as corneal abrasions and bacterial infections [6]. - The association reported that there are about 5 to 10 cases annually due to improper use of contact lenses, with severe cases potentially leading to corneal transplants [6]. - Consumers are advised to avoid purchasing unknown products online and to ensure that contact lenses come with proper packaging and barcodes [6].

| 42 上海钧翔医疗器械有限公司 | 2025-09-08 | 沪嘉食药监械经营备20150090号 | 三级 | 其他 | 飞行 | 韩添 | 限期整改 | 伊,张 | (无需现场) | 监管 | 检查 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 举纲 | 江云, | 三级 | 通知 | | | | | | | | | | | | 沪嘉药监械经营备20240036号 | 43 上海卫锦医疗科技有限公司 | 无菌类 | 2025-09-08 | 去向不明 | 监管 | 检查 | 潘佳 | | | | | | | | 于凌 | 二级 | 通知 | 44 上海捷龙医疗设备有限公司 | 沪嘉食药监械经营备20210050号 | 2025-09-08 | 慧,甘 | 其他 | 通过检查 | 监管 | 检查 | | | | | 春生 | 张一 | | | | | | | | | | | | | | 一级 | 通知 | 45 上海顺源佳泰药店 | 沪嘉食药监械经营备201501 ...

Summary of Medical Device Supervision Inspection Results in Shanghai Core Viewpoint The inspection results of medical device operating enterprises in Shanghai for June 2025 indicate a generally positive compliance status, with many companies passing inspections or being allowed to continue operations after necessary corrections. Group 1: Inspection Results - Shanghai Guoda Guangyuan Pharmacy Co., Ltd. passed the inspection on June 2, 2025 [4] - Shanghai Senhui Family Health Technology Development Co., Ltd. passed after rectification on June 3, 2025 [4] - Shanghai Shangjiu Medical Device Co., Ltd. was notified for limited rectification [4] - Shanghai Jiuying Trading Co., Ltd. passed the inspection on June 4, 2025 [4] - Shanghai Ligu Medical Technology Co., Ltd. passed after rectification on June 4, 2025 [4] Group 2: Categories of Medical Devices - Companies inspected include those dealing with medical protective equipment, sterile products, implant materials, and other categories [4][5] - The inspection results cover various levels of regulatory compliance, including Class I, II, and III devices [4][6] Group 3: Compliance and Rectification - Several companies were allowed to continue operations after making necessary corrections, indicating a proactive approach to compliance [5][6] - Companies such as Shanghai Yifeng He Xuan Pharmacy Co., Ltd. and Shanghai Aiyang Biotechnology Co., Ltd. passed inspections on June 5, 2025 [6][7] - The inspection process emphasizes the importance of maintaining standards in the medical device industry to ensure safety and efficacy [6][8]