Core Points - The Shandong Provincial Drug Administration has organized a special inspection of medical device import agents to ensure compliance with their responsibilities [1] - The focus of the inspection includes the registration varieties of medical devices, the obligations of import agents, and the monitoring of product quality and adverse events [1] - A total of 14 medical device import agents have been inspected, with issues identified requiring companies to rectify within a specified timeframe [1] - The administration is also providing targeted explanations of relevant laws and regulations to enhance the legal and responsibility awareness of import agents [1] - Future efforts will include strengthening regulatory oversight, investigating illegal activities, and ensuring effective follow-up and rectification to safeguard public safety [1]

Policy Developments - The National Medical Products Administration (NMPA) is focusing on the quality supervision of selected drugs in centralized procurement, emphasizing the importance of quality safety and compliance in production [1] - The NMPA will implement comprehensive production inspections and product sampling for selected drugs, optimizing work mechanisms and exploring risk monitoring [1] - The NMPA acknowledges the development of the medical device industry in Chongqing and stresses the need for a robust quality safety responsibility system [2] Drug and Device Approvals - Baiyunshan's subsidiary Zhongyi Pharmaceutical received a registration certificate for the traditional medicine An Gong Niu Huang Wan from Vietnam's Ministry of Health, aiding market expansion [3] - Huyou Pharmaceutical announced that its subsidiary Seacross Pharmaceuticals Ltd. received marketing approvals for multiple products from regulatory authorities in Pakistan, the UK, and North Macedonia [4] - Zhifei Biological's recombinant herpes zoster vaccine (ZFA01) clinical trial application has been accepted by the NMPA, which may enhance vaccine efficacy [5] Capital Market Activities - Puluo Pharmaceutical plans to repurchase shares worth between RMB 180 million and RMB 360 million, with a maximum price of RMB 23 per share [6][7] - Sinovac Biotech received a delisting notice from NASDAQ due to failure to submit its annual report by the deadline, with potential trading suspension imminent [8] Industry Developments - Researchers published a detailed immune response map following pig kidney transplants in brain-dead patient models, identifying key factors for transplant success [9] - Haizheng Pharmaceutical's subsidiary plans to collaborate with the East China Institute for the biomanufacturing of heparin, with a project budget not exceeding RMB 120 million [10] Public Sentiment Alerts - Guangyuyuan announced the resignation of Vice President Wang Junbo due to work adjustments, effective immediately [11] - Medici's shareholder Chen Guoxing plans to reduce his stake by up to 1.64% through trading methods due to personal financial needs [12]

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].

Core Points - The article presents the results of regulatory inspections for medical device companies in Shanghai, highlighting compliance and areas needing improvement [4][5][6][7] Group 1: Inspection Results - Shanghai Tinghe Technology Co., Ltd. passed the inspection for sterile products and implant materials on September 1, 2025 [4] - Shanghai Xinzhu Science and Trade Co., Ltd. required rectification but passed after improvements on September 1, 2025 [4] - Shanghai Haiyuyang Medical Technology Co., Ltd. successfully passed the inspection for medical devices on September 1, 2025 [4] - Shanghai Bobo Bibi Internet Technology Co., Ltd. passed the inspection for corneal contact lenses on September 1, 2025 [4] - Shanghai Hantao Medical Technology Co., Ltd. was given a deadline for rectification on September 1, 2025 [4] Group 2: Regulatory Categories - Companies were categorized into different regulatory levels, with most being classified as Level 2 or Level 3, indicating varying degrees of oversight [4][5] - The inspections covered various categories including sterile products, implant materials, medical protective equipment, and diagnostic reagents [4][5][6] Group 3: Compliance Status - A significant number of companies, including Shanghai Yirun Link Technology Group Co., Ltd. and Shanghai Jialong Radiation Protection Technology Co., Ltd., passed inspections without issues [4][5] - Several companies, such as Shanghai Furan Health Management Co., Ltd., required rectification but ultimately passed after improvements [4][5][6] - The inspections were conducted on various dates, primarily in early September 2025, with a focus on ensuring compliance with health and safety regulations [4][5][6][7]

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]