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The 15th China International Conference on Medical Device Regulatory Affairs Kicks Off with Great Fanfare

The 15th China International Conference on Medical Device Regulatory Affairs will be held in Suzhou from August 26 to 28, 2025, aiming to drive innovation and growth in the medical device industry. This year’s conference will continue to focus on global trends in medical device innovation, the challenges posed by cutting-edge products and technologies, as well as key issues and bottlenecks faced by regulatory bodies and industry development. Attendees will have the opportunity to share insights into the latest international regulations and initiatives for medical devices, along with China’s new policies, technical guidelines, industrial advancements, and collaborative opportunities in the medical device sector.

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National Medical Products Administration Announces Abolishment and Amendments to Selected Medical Device Industry Standards—Policy Interpretation

On September 1, the National Medical Products Administration (NMPA) issued an announcement (No. 80 of 2025) announcing the abolition of five medical device industry standards, including "Medical Device Industry Standard Development—Part 1: Phase Division, Codes, and Procedures." At the heart of this announcement is the goal to streamline and optimize the medical device standards system. The decision to retire the outdated standards paves the way for new ones that are more scientifically sound and better aligned with the evolving needs of industry development and regulatory oversight.

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3D-Printed Transcatheter Pulmonary Valve Replacement Simulator: Development and Validation

This study introduces a novel training tool designed to enhance teaching and training methods related to TPVR. Patient-specific models can be effectively used for both pre- and post-operative planning, and trained physicians not only demonstrated improved performance after the training but also outperformed their untrained counterparts significantly. Importantly, this approach helps minimize radiation exposure and surgical risks. Incorporating 3D-printed models into medical training markedly deepens doctors' understanding of the anatomical structures and pathophysiological features associated with cardiovascular diseases. Additionally, it sharpens their surgical skills, boosting overall training effectiveness, shortening the learning curve, and enriching hands-on experience. While current simulators may not yet deliver a completely realistic simulation experience, their consistently reliable performance underscores their immense potential for future clinical applications.

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Ministry of Finance: Government procurement projects for medical devices exceeding 45 million yuan should exclude EU-based companies (including policy Q&A interpretations).

On July 6, 2025, China's Ministry of Finance issued a significant notice announcing restrictive policies on the import of medical devices. The policy stipulates that when procuring medical equipment with budget amounts exceeding 45 million RMB, buyers must exclude European Union-based companies (excluding EU-invested enterprises already operating in China) from participating—provided that importing products is deemed absolutely necessary after following the legally mandated procedures. Meanwhile, for non-EU companies involved, the proportion of medical devices sourced directly from the EU cannot exceed 50% of the total project contract value. The introduction of this policy has sparked widespread attention and intense debate across the medical device industry—and even throughout the broader economic sector. On July 10, the Ministry of Finance further released "Policy Q&A on Measures to Be Taken Against Medical Devices Imported from the EU in Government Procurement Activities," providing clear explanations addressing key questions about how the policy will be implemented, thereby offering more precise guidance for its effective application.

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Decoding the 2025 Hypertension Prevention and Control Guidelines: Diagnostic thresholds remain unchanged, treatment strategies are advanced, and RDN officially gains recognition.

The release of the 2025 American College of Cardiology (ACC)/American Heart Association (AHA) Clinical Guidelines on Hypertension sets the direction for hypertension prevention, treatment, and the development of related technologies. As a major modifiable risk factor contributing to heart attacks, strokes, and even death, hypertension remains a global health challenge despite the increasing availability of both pharmacological treatments and lifestyle interventions. Unfortunately, despite these advances, blood pressure control worldwide remains far from ideal: an estimated 1.28 billion adults globally are affected by hypertension, yet over 80% of patients fail to achieve effective blood pressure management. The advent of renal denervation via catheter-based procedures (RDN) offers a groundbreaking innovation that could help break through longstanding therapeutic barriers.

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The complete process of medical devices, from design and development to market launch

From design and development to final market launch, medical devices must systematically go through several rigorous stages—such as product design and development, establishment of a quality management system, registration testing, clinical evaluation, regulatory submissions, and applications for manufacturing licenses. This entire process is time-consuming and requires significant financial investment. For startups, it’s crucial to carefully assess the risks, timelines, and associated costs. Drawing on industry best practices, this article provides a clear and practical guide to help companies navigate this complex process effectively.

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Requirements for the use of 2D/3D vascular models in the development process of vascular intervention products during device review

According to monitoring by a professional institution, DeWei Medical's simulation models closely mimic the elasticity and friction coefficient of normal human blood vessels. The silicone vessels exhibit an Shore A hardness ranging from 20 to 50, while their compliance levels fall between 2% and 15% per 100 mmHg. Additionally, the thinnest vessels can achieve an inner diameter as small as 1.5 mm.

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Comprehensive Interpretation of the "2025 Expert Consensus on Clinical Pathways for Transcatheter Left Atrial Appendage Closure in China"

The release of the 2025 consensus marks a milestone: for the first time, China’s original "simplified LAAC procedure" has been incorporated into standardized clinical pathways, making it the world’s first guideline document to systematically outline this technique. Additionally, building on "Left Atrial Appendage Intervention for Preventing Thromboembolic Events in Patients with Atrial Fibrillation: Current Understanding and Recommendations (2023)," the consensus now offers Class I recommendations (with evidence levels A/B) specifically for certain patient groups—such as those with long-term contraindications to anticoagulation or those undergoing left atrial appendage electrical isolation—significantly elevating the role of LAAC in the comprehensive management of atrial fibrillation.

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Minimally Invasive ® Coronary FireShield™ Coronary Covered Stent Attracts Attention—Derway Medical Provides Validation Support for Testing of Similar Devices

近日，上海微创医疗器械（集团）有限公司（以下简称 “微创 ® 冠脉”）宣布其火盾™冠脉覆膜支架系统（以下简称 “火盾™”）的上市前关键性临床研究（CONVOY 研究）已顺利完成全部患者入组。这一里程碑事件不仅标志着我国在冠脉介入急救领域即将迎来更优的 “中国方案”，也彰显了国产医疗器械在创新之路上的坚实步伐，而专注于仿真血管模型研发与应用的德为医疗，始终致力于为这类高端医疗器械的研发与验证提供精准支持。

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Academician Wang Jian'an's team achieves a major breakthrough in cardiovascular interventional therapy with the FLAVOUR II study featured on the cover of *The Lancet*.

On March 30, 2025, the prestigious international medical journal *The Lancet* published online the latest research findings from the team led by Professor Jian'an Wang, an academician of the Chinese Academy of Sciences and director of the Second Affiliated Hospital of Zhejiang University School of Medicine—the FLAVOUR II study. The study was simultaneously unveiled as a groundbreaking Latest Breakthrough Clinical Trial (LBCT) at the 2025 American College of Cardiology Annual Scientific Session (ACC.25), drawing significant attention from the global academic community.

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Pioneering the pulmonary artery vascular model, DeWe Shining at the "1st Western Pulmonary Vascular Science Conference"

From June 19 to 22, 2025, the "1st Western China Pulmonary Vascular Science Conference," hosted by the Beijing Health Promotion Association and academically supported by the Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, was held grandly in Chengdu. This prestigious academic event, bringing together leading experts from home and abroad, featured the theme "Opening a New Chapter—Fusing Innovation" and focused on cutting-edge advancements in the diagnosis, treatment, and research of pulmonary vascular diseases.

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DeWei Medical's intelligent blood flow platform supports innovative applications of Zhongtian Medical's neurointerventional devices.

At OCIN & WLNC 2025, Zhongtian Medical proudly unveiled its globally pioneering woven microguidewire "Tianzhi™" and the all-scenario thrombus aspiration catheter "Tianjiao™." DeWei Medical, a technology company specializing in intelligent medical simulation systems, leverages its seasoned core team—veterans in medical simulation innovation—to deliver cutting-edge solutions. With their innovative neurointerventional vascular models and intelligent blood flow platform, DeWei is supporting Zhongtian Medical in advancing groundbreaking applications within the field of neurointervention.

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