（通讯员 韩剑报道）为规范体验式医疗器械经营秩序，保障群众尤其是老年群体用械安全。近期新疆 沙湾市市监局聚焦辖区内体验式医疗器械店"先体验后销售"模式开展专项整治行动。 下一步，新疆沙湾市市监局将持续开展常态化监管，畅通投诉举报渠道，加大普法宣传力度，凝聚多元 共治合力，切实保障群众用械安全 本次行动采取突击检查与精准摸排相结合的拉网式排查，聚焦医用康复类、物理治疗类等体验式医疗器 械经营主体为重点排查对象，执法人员重点核查经营资质、产品注册备案凭证、进货查验记录及严查无 证经营、超范围经营、虚假宣传等违法违规行为，杜绝以"免费体验""赠送礼品"等隐蔽误导的消费现 象。整治行动中以"执法+规范+普法"三位一体，对台账记录不规范等问题现场指导立查立改。同时向 群众普及用械安全和维权知识，向经营主体现场宣贯相关法律法规，压实主体责任。 此次整治行动有 效规范了体验式医疗器械经营市场秩序，强化了经营主体守法经营意识。 ...

西市监处罚〔2025〕2108号 浏览：2次 基本信息： 处罚依据 《医疗器械监督管理条例（2021修订）》 / 第八十八条 / 第二项 变更： 文本信息：该行政处罚决定未上传处罚文书。 西安市市场监督管理局 处罚日期 2025年12月29日 处罚种类 罚款,没收违法所得 处罚机关 ...

Regulatory Developments - The National Medical Products Administration (NMPA) held a meeting on post-market regulation of medical devices, emphasizing the need for a balance between safety and industry vitality while planning for 2026 [1] - The NMPA approved the long-acting growth hormone injection, Nozeyou®, developed by Novo Nordisk, marking it as the first international original long-acting growth hormone for children in China [4] - Changchun High-tech's subsidiary, GenSci, received acceptance for a clinical trial application for GenSci141 ointment, which aims to address various hormonal deficiencies in children [5] - Jiukang Bio announced the acquisition of medical device registration certificates for two diagnostic kits, enhancing its product line in the in vitro diagnostic sector [6] Market Activities - Suzhou Tongxin Medical Technology's IPO application was accepted, with plans to raise 1.064 billion yuan for various projects including the production base for implantable left ventricular assist devices [8][9] - Zhendong Pharmaceutical announced a partnership to establish a fund focused on investments in the biopharmaceutical sector, contributing 30 million yuan as a limited partner [11] Corporate Changes - Baihua Pharmaceutical is planning a change in control, leading to a temporary suspension of its stock trading [10] - *ST Changyao is under investigation for alleged financial misconduct, which may lead to a forced delisting due to false financial reporting [18]

Core Viewpoint - Tianyi Medical, a manufacturer of blood purification consumables, faces administrative penalties from the Ningbo Market Supervision Administration for producing medical devices that do not comply with registered technical requirements, with total penalties amounting to approximately 14.0179 million yuan [1][2]. Group 1: Regulatory Actions - The Ningbo Market Supervision Administration issued an administrative penalty notice to Tianyi Medical for failing to produce blood purification devices according to registered technical specifications, which constitutes a violation of the Medical Device Supervision and Administration Regulations [1]. - The penalties include the confiscation of 7,170 sets of illegally produced medical devices, the confiscation of illegal gains amounting to 523.27 million yuan, and a fine of 878.52 million yuan [2]. Group 2: Company Overview - Tianyi Medical specializes in the research, production, and sales of medical polymer consumables in the fields of blood purification and ward care, with key products including blood purification devices, disposable venous and arterial puncture devices, and blood dialysis concentrates [2]. - For the first three quarters of 2025, Tianyi Medical reported a revenue of 387 million yuan, representing a year-on-year increase of 24.14%, and a net profit attributable to shareholders of 20.0941 million yuan, up 216.81% year-on-year [2]. Group 3: Operational Status - Tianyi Medical stated that the regulatory issues will not lead to a situation that triggers mandatory delisting, and the company's production and operations remain normal [3].

Core Viewpoint - Tianyi Medical (301097.SZ) has received an administrative penalty notice from the Ningbo Market Supervision Administration for allegedly failing to produce medical devices according to registered technical requirements, which may lead to significant financial penalties and operational adjustments [1][2]. Group 1: Administrative Penalty Details - The company was notified on December 19, 2025, regarding the administrative penalty for not adhering to the registered technical requirements for the production of blood purification devices [1]. - The investigation concluded that Tianyi Medical produced blood pathway products that did not comply with the registered specifications, violating the Medical Device Supervision and Administration Regulations [2]. - The proposed penalties include the confiscation of 7,170 sets of illegally produced medical devices and a fine totaling approximately 8.79 million yuan, along with the confiscation of illegal gains amounting to about 5.23 million yuan [2]. Group 2: Financial Impact - The total financial penalty for Tianyi Medical amounts to approximately 14.02 million yuan [3]. - The company went public on April 7, 2022, with an initial share price of 52.37 yuan, raising a total of approximately 77.18 million yuan in its IPO [3][4]. - The net proceeds from the IPO were about 69.46 million yuan, which was higher than the initially planned amount by approximately 18.45 million yuan [4].

Core Viewpoint - Tianyi Medical has been penalized for producing medical devices that did not comply with registered technical requirements, resulting in the confiscation of 7,170 sets of illegal products and a fine of 14.02 million yuan [1][2]. Group 1: Regulatory Issues - The company was found to have produced blood purification devices that did not meet the specified technical requirements, violating the Medical Device Supervision and Administration Regulations [2]. - The Ningbo Market Supervision Administration noted that the involved products are classified as high-risk medical devices and require strict management [1]. Group 2: Company Response and Penalties - Tianyi Medical cooperated with the investigation, recalled some of the involved products, and implemented corrective measures, which led to a reduction in penalties [2]. - The penalties imposed include the confiscation of 7,170 illegal medical devices, confiscation of illegal gains amounting to 5.23 million yuan, and a fine of 8.79 million yuan [2]. Group 3: Financial Performance - For the first three quarters of the year, the company reported a revenue of 387 million yuan, representing a year-on-year increase of 24.14% [3]. - The net profit attributable to the parent company was 20.09 million yuan, showing a significant year-on-year growth of 216.81% [3]. - The net profit after deducting non-recurring gains and losses reached 8.41 million yuan, with a remarkable increase of 762.11% year-on-year [3]. Group 4: Market Performance - On December 24, Tianyi Medical's stock price increased by 0.48%, closing at 54.87 yuan per share, with a total market capitalization of 3.234 billion yuan [4].

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].