BradyKnows Medical

🔔 NMPA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites 🚀 📅 On June 14, 2024, China NMPA released new guidelines aimed at enhancing the management of clinical trial institutions for medical devices. These guidelines ensure compliance with regulatory standards and safeguard public health by providing a structured approach for drug regulatory authorities to supervise and inspect medical device clinical trial institutions. Scope and Purpose 📋 The guidelines are intended for drug regulatory authorities to use when organizing supervision and inspections. They help assess the qualifications, management, and operational practices of clinical trial institutions, ensuring adherence to laws such as the Regulations on the Registration and Filing of Medical Devices and the Good Clinical Practice (GCP) for Medical Devices. Key Inspection Areas 🔍 The guidelines outline 16 inspection areas covering 96 specific items, divided into institutional qualifications and clinical trial professional standards. Each item is categorized as critical (★), major (★), or general based on its impact on trial quality and safety: - Critical items: 8 - Major items: 43 - General items: 45 Inspection Findings and Deficiency Classification 🔎 Deficiencies identified during inspections are classified into three levels: 1. 🛑 Serious deficiencies: Linked to non-compliance with critical items. 2. ⚠️ Major deficiencies: Associated with major items. 3. ⚪ General deficiencies: Related to general items. Detailed Inspection Items 📝 The guidelines provide detailed checklists for assessing various aspects of clinical trial institutions, including: - Institutional qualifications and conditions (e.g., licensure, facilities, equipment) - Organizational management (e.g., clinical trial management departments, trained personnel) - Filing-keeping and data traceability - Ethical review processes (e.g., functioning ethics committees, training for ethics committee members) - Compliance with GCP standards Implementation and Compliance 🔧 Implemented on a trial basis, these guidelines will be refined based on inspection feedback. Institutions are encouraged to familiarize themselves with the detailed inspection points to ensure compliance with the standards. 📧 For further information and detailed inspection checklists, please contact: [info@bradyknowsmedical.com]

📢 China NMPA Implements Revised Classification Catalog for In Vitro Diagnostic Reagents 🧪 On May 21, 2024, the China NMPA announced the implementation of the revised Classification Catalog for In Vitro Diagnostic Reagents (IVD), in line with the Regulations for the Supervision and Administration of Medical Devices (State Council Order No. 739). This revision, aimed at enhancing the regulatory framework for IVD reagents, will take effect on January 1, 2025. 🔍 Key Highlights: **Separate Management Categories**: Products with the same analytes but different clinical purposes will be categorized separately based on their clinical applications. **Risk-Based Classification**: Reagents used for microbiological identification, drug sensitivity tests, cell culture media, and other specific reagents will be classified according to their risk and intended use. **Dynamic Updates**: The catalog will be updated dynamically based on risk analyses and evaluations of medical device production, operation, and usage. 📅 Transition Policies: - From now until June 30, 2024, entities can use either the original or revised catalog for filing IVD reagents. - From July 1, 2024, the revised catalog must be used for all new filings. - Existing products must be reviewed for compliance with the new catalog, with adjustments made by January 1, 2027. 🚀 BradyKnows Medical stands at the forefront of medical device innovation, providing elite expertise in the regulatory landscape of IVD reagents. Our comprehensive knowledge and meticulous approach ensure seamless compliance with evolving regulations, making us an invaluable partner in navigating the complexities of medical device classification and registration. For further inquiries regarding medical device registration, please contact us at 📧 info@bradyknowsmedical.com.

🔍 **Breaking News: CT Angiography Software Approved for Intracranial Aneurysm Detection by China NMPA** A significant stride in medical imaging! China NMPA has granted approval to an innovative CT angiography software designed for the precise detection of intracranial aneurysms. 🧠 **How It Works:** This cutting-edge software, comprising browser-side and server-side components, is tailored for displaying, processing, and analyzing head and neck CT angiography images. Its specialized focus is on detecting intracranial aneurysms measuring 3mm and above. 🌟 **Key Features:** Using advanced techniques such as head and neck vascular centerline extraction and vessel segmentation, this software elevates the sensitivity of aneurysm detection to new heights. 💡 **Impact on Healthcare:** The approval of this software marks a pivotal moment in enhancing patient care, improving quality of life, and potentially increasing survival rates for those at risk. 🛡️ **Ensuring Safety:** Post-approval, regulatory authorities are committed to rigorous supervision to uphold patient safety standards. 🤝 **Connect with BradyKnows:** For inquiries on innovative product registration in China, reach out to [BradyKnows](mailto:info@bradyknowsmedical.com). They've helped numerous clients navigate this process successfully.🎉 #MedicalImaging #InnovationInHealthcare

China NMPA Approves Disposable Cardiac Pulse Field Ablation Catheter

🔔 Exciting news about China National Healthcare Security Administration Office Issues Notice on the Release of Medical Centralized Procurement Platform Service Standards

#Export2China We are thrilled to announce that Medtech China team in UK Department for Business and Trade will launch the report: Easy Guide to UK-China Medical Device Market Access and Lifecycle Compliance on January 17. The report is tailor-made for UK’s medical devices companies, especially SMEs, to better navigate the world’s second largest medical devices market, right after the US. In partnership with BradyKnows, the report is structured into three informative sessions that cover essential insights for successful market entry. We will host an online seminar with two separate sessions on January 17 and 24 on Zoom. You may check out the agenda below. Please sign up for the event and get the report before these two informative sessions. Our team members will be happy to answer your questions after we present the highlights of this report. Join us and get started to UNLEASH YOUR EXPORT POTENTIAL to China, the world’s second largest economy with 1.4 billion people, and with increasing spending on healthcare. #healthcare #medicaldevices #china #marketaccess #SMEs BradyKnows MedicalCynthia HAN Gary Hunt Rahul AgarwalVicky Zhang Meng XueSusan Jiang

🌐 Join Our Exclusive Webinar! Unlock the Gateway to the Chinese Medical Device Market 🚀 UK-China Medical Device Access to China-Session 2: Targeting Unmet Medical Needs in China's Growing Market 📅 Date & Time: 24 January, 2024, 14:00 – 15:00 London GMT (22:00 – 23:00 Beijing CST) 🔍 Agenda Highlights: 🎉 Introduction 🌐 Uncover the Landscape of Unmet Medical Needs in China 🚀 “Green Channels” for the Market Access of UK Medical Devices to China ❓ Q&A Session 🌟 Why Attend? Are you looking to launch your medical device in China? Join us for valuable insights and strategies presented by industry experts. Our session will equip you with the knowledge needed to navigate the intricate landscape of medical device regulations in China. 🔗 Consult with BradyKnows Medical: Your Gateway to Success in China Whether you're a seasoned professional or new to the market, our experts at BradyKnows Medical are here to guide you. Seize this opportunity to consult with us and pave the way for a successful product launch in China. 📌 Register Now to Secure Your Spot! [https://lnkd.in/eNtaKm3J] Don't miss out on this chance to expand your medical device reach into China! 🚀🌏

🌐 Join Our Exclusive Webinar! Unlock the Gateway to the Chinese Medical Device Market 🚀 UK-China Medical Device Access to China-Session 2: Targeting Unmet Medical Needs in China's Growing Market 📅 Date & Time: 24 January, 2024, 14:00 – 15:00 London GMT (22:00 – 23:00 Beijing CST) 🔍 Agenda Highlights: 🎉 Introduction 🌐 Uncover the Landscape of Unmet Medical Needs in China 🚀 “Green Channels” for the Market Access of UK Medical Devices to China ❓ Q&A Session 🌟 Why Attend? Are you looking to launch your medical device in China? Join us for valuable insights and strategies presented by industry experts. Our session will equip you with the knowledge needed to navigate the intricate landscape of medical device regulations in China. 🔗 Consult with BradyKnows Medical: Your Gateway to Success in China Whether you're a seasoned professional or new to the market, our experts at BradyKnows Medical are here to guide you. Seize this opportunity to consult with us and pave the way for a successful product launch in China. 📌 Register Now to Secure Your Spot! [https://lnkd.in/eNtaKm3J] Don't miss out on this chance to expand your medical device reach into China! 🚀🌏

🚀 Approval Granted for Stomach Bypass Stent System! 📅 On January 17th, the NMPA gave the green light to the innovative Stomach Bypass Stent System. This milestone marks the approval of the product registration application. 🛠️ Product Overview: - The system comprises a delivery and retrieval system. - Delivery System:Includes a delivery device, stomach bypass stent, and guide wire. - Retrieval System:Consists of a retrieval tube, retrieval hook, and retrieval cap.    👩⚕️ Target Audience: - Designed for patients with obesity. - Intended for those for whom lifestyle adjustments, non-invasive treatments, and drug therapies have proven ineffective.    🔍 How It Works: - Implantation with a gastroscope in the duodenum and upper jejunum. - Achieves effects similar to gastric bypass surgery without altering the gastrointestinal tract's physiological structure. - Reduces nutrient absorption, aiming to facilitate weight loss.    🌐 Post-Market Supervision: - Regulatory authorities will enhance post-market supervision to ensure patient device safety. 🌟 BradyKnows Medical's Commitment: - As a pioneer in medical technology, BradyKnows Medical is dedicated to advancing medical device registration solutions. - Explore our strategic solutions for medical devices globally on the BradyKnows Medical website. 🔗 Learn more about our groundbreaking medical solutions: [BradyKnows Medical Website](News | BradyKnows (bradyknowsmedical.com) #MedicalInnovation #HealthcareAdvancements**

🔍Opinions on the Review of Clinical Registration of "Facial Injectable Filler" 📢 Introduction: The China NMPA's Medical Device Technical Review Center has invited public opinions on four crucial guidelines for the registration review of medical devices. Notably, this includes guidelines for the clinical trial registration review of "Facial Injectable Filler." 🔍 Key Points: 1. Facial Injection Product Scope:   - Addressing the correction of various facial features using different materials.   - Notable products include hyaluronic acid gel, collagen, polymethyl methacrylate implant systems, Poly-L-lactic acid, and poly-caprolactone facial fillers. 2. Safety Evaluation Indicators:   - Highlighting key safety indicators, including injection reactions, allergic reactions, infections, and other potential complications. 3. Clinical Evaluation Indicators:   - Primary and secondary clinical evaluation indicators, emphasizing the duration of effectiveness and additional assessments for specific products. 4. Product Manual Development:   - Stressing the importance of comprehensive product manuals with information on possible complications and side effects. 👩⚕️ Implications for Medical Professionals and Consumers: This information is crucial for ensuring the safe and effective use of facial injection products, aligning with the standards set by the NMPA. 📚 For More Information: Explore the comprehensive offerings on the BradyKnows Medical Aesthetic website for detailed insights into state-of-the-art Medical Aesthetic Devices and their application in the Chinese market. [Opinions on the Review of Clinical Registration of “Facial Injectable Filler” | BradyKnows (bradyknowsmedical.com)] #MedicalDevices #FacialAesthetics #NMPA #ClinicalRegistration #MedicalRegulation #HealthcareGuidelines #BeautyIndustry