English medical device CRO resources

English Insights

English medical device CRO insights from Clinsota, covering clinical evaluation, CE MDR, FDA 510(k), NMPA registration, PMCF, PMS, PSUR and deficiency letter response.

Team-NB Position Paper on Clinical Evaluation Based on Non-Clinical Data: MDR 2017/745 Article 61(10)A practical interpretation of Team-NB’s position on when manufacturers may rely on non-clinical data for clinical evaluation under EU MDR Article 61(10), and what Notified Bodies expect to see in the justification.Clinsota invites you to attend the 3rd MDI Conference to explore “AI Agents Accelerating Global Market Access: Addressing the Core Challenges in Clinical Evaluation and Global Registration”To accelerate innovation and resource integration in the medical device industry and deepen collaboration among industry, academia, research, and clinical practice, the “2026 MDI-China Medical Device Innovation & Collaboration Conference” (the 3rd MDI Conferen[Policy Interpretation] UK Clinical Trials Approved in as Fast as 7 DaysMHRA has now incorporated the Route B fast-track pathway into UK regulations, allowing low-risk clinical trial modifications to be approved in as little as 7 days. This article outlines the scope of applicability, fees, document checklist, and common risks.[News] Clinsota enabled a company to achieve EU clinical compliance for Class III and Class IIb high-risk combination products in just 5 monthsAmid the challenging EU MDR landscape for medical-device clinical compliance, Kelin Data has good news to share: a complex coronary calcification intravascular lithotripsy (IVL) combination device that we supported successfully passed the EU pre-market clinicaMajor Update: Free Full-Day Online EUDAMED Database Training Open to the Entire Industry by the European Commission Directorate-General for Health and Food SafetyThe implementation of the EU MDR/IVDR has entered a critical stage. On May 28, 2026, mandatory EUDAMED modules will become operational, including Actor Registration, UDI/Device Information, and Notified Bodies and Certificates. To support a smooth transition fGlobal Registration Strategy and Compliance AI Deployment for CGM: Insights from CMEFCGM Global Registration Strategy and Global Compliance AI PracticeHow to bridge NMPA-compliant Clinical Evaluation evidence with international clinical regulatory complianceAgainst the backdrop of increasingly stringent global medical device regulation, how can Chinese clinical data truly gain international acceptance?The “Global GCP Standard” for Medical Device Clinical Trials, ISO 14155:2026, Has Been Officially ReleasedGap Analysis: ISO 14155:2026 (GCP), the leading international standard for global medical device clinical research, vs. the 2020 editionProvisions on Implantable Devices and the List of Class III Medical Devices Exempt from Clinical TrialsList of Certain EU Class IIb Implantable Devices and Class III Devices Exempt from Clinical InvestigationShenzhen Clinsota to Exhibit at CMEFCMEF 2026 3rd Continuous Glucose Monitoring (CGM) Technology Seminar (Morning of April 10 · Shanghai)Shenzhen Clinsota to Exhibit at CMEF2026｜Presentation on Global CGM Registration Strategies and Clinical Compliance SolutionsBest wishes for a successful start to work, with smooth progress and smooth approvals!Original link: https://mp.weixin.qq.com/s/kGzDmmrZY5Nd9bxIDFTXpQ Note: This article uses a special WeChat template page (no extractable main-content container); the title, summary, and cover image have been synchronized.Galloping into 2026 · Embarking on a New Journey TogetherAs the seasons turn, a new chapter unfolds.\x0aOn the occasion of the Chinese New Year, ClinSota extends to you our sincerest New Year wishes!\x0a\x0aMay 2026 bring you:\x0aGalloping momentum and new heights\x0aSuccess at every turn and smooth progress in all Detailed Interpretation of the New National Standard GB/T 46857.1-2025: An Upgrade Guide to Medical Equipment O&M Services and a Quick View of Corporate Compliance StrategiesThe new national standard GB/T 46857.1-2025 has been released, standardizing medical equipment O&M services and improving industry efficiency and safety. Practitioners should review processes, train their teams, and act early to capture the opportunity.How Will ISO 18969, the First International Standard for EU Clinical Evaluation, Affect Corporate Clinical Strategy?Interpreting ISO 18969, the First International Standard for EU Clinical Evaluation: How Should It Be Used Together with EU MDR and MDCG?OpenAI Launches ChatGPT Health: Healthcare Will Not Be Replaced by AI, but It Will Be Reorganized by AIOpenAI Enters AI Healthcare: ChatGPT Health Goes LiveFDA 2026 User Fee Increase: Companies Exporting to the U.S. Should Watch for Cost ChangesFDA User Fee Increases vs. NMPA: SMEs Exporting to the U.S. Need to Reassess Costs and StrategyApple Watch AFib Feature Finally Receives NMPA Class II Approval: A New Growth Opportunity in Wearable Medical Devices and Practical Regulatory TakeawaysApple Watch AFib Feature Receives NMPA Class II Approval! A New Wearable Medical Device Segment Is Opening Up: Algorithm validation has a high bar, and RWD evidence is critical. A CRO can help you plan the Class II pathway and capture the chronic disease monitFree Live Webinar--A Complete Guide to EU Clinical Evaluation: From Overall Strategy to Efficient and Precise Literature SearchingOne of the Most Challenging Areas in Global Medical Device Clinical Compliance: EU Clinical Evaluation, the Core Determinant of CE Marking SuccessThe Surgical Robot Registration Race IntensifiesFrom De Novo to 510(k), surgical robot regulatory pathways are diverging, and the logic of industry competition is quietly changing.FDA Releases a Summary of the 2026 Medical Device Guidance AgendaA-List Highlight: Final RWE Guidance + Final AI/ML PCCP Guidance Are About to Land, and the window for specialist CROs to position early is now openFDA Relaxes Oversight of Health and Fitness Wearables: Non-medical-grade Data Will Not Be Regulated!Commissioner Makary Announces: Non-medical-grade data from health and fitness wearables will not be regulated! New guidance makes clear that low-risk general wellness products do not require stringent review, accelerating consumer innovation while preserving tNew FDA CDS Guidance: Which Software Can Stay Outside Device Regulation, and Which Falls Back Under It?Not a medical device, or still subject to regulatory submission? The latest FDA CDS guidance provides a clear answerEU Clinical Investigation CIP Practical Guide: A Clear Explanation of the Regulatory Thinking Behind MDCG 2024-3EU Clinical Investigation Practice GuideHow We Used a COCIR White Paper to Persuade the Reviewer to Accept the MDR 61(10) RouteConducting a Clinical Evaluation Based on Performance Data Under MDR Article 61(10)Deep Dive into the BSI White Paper: MDR Article 61(10)—How to Complete a Clinical Evaluation Using Non-Clinical Data in “Exceptional Circumstances”BSI Perspective: Case Analysis of EU Clinical Evaluation Under Article 61(10)Stop Buying “Miracle” Sleep Aids: 3 Hard-Hitting Sleep Recommendations from NatureMany People Cannot Sleep Because They Are Not Living Right During the Day | NatureYY/T 1987—2025 “Terminology for Medical Devices Using Brain-Computer Interface Technology” effective January 1, 2026YY/T 1987-2025 is China’s first standard for brain-computer interface medical devices, systematically defining 80+ core terms, such as “invasive brain-computer interface medical device”Expert Guide and Consensus on Cardiovascular Wearable Devices: How to Keep Registration and Clinical Compliance on Track?In-depth analysis of expert recommendations for cardiovascular wearable devices, with a CRO-specific implementation playbook to help you avoid 90% of clinical detours~A Practical Guide to State of the Art (SOTA) in EU MDR Clinical EvaluationState of the Art in MDR Clinical Evaluation: More Than Just a Literature Review, a Writing Framework That Can Withstand Notified Body Scrutiny[Material Sharing] Compilation of 500+ Device Review Reports500+ Approved Review Reports: Copy Compliant Templates Directly and Save 3 Months! ✅ Missing dossier items? Just copy the “approved checklist.” These two cases show it: the Siemens CT review report explicitly required supplementary “safety and performance veriA Year-End LetterStaying True to Our Original MissionAfter the MDCG update, what fundamental questions will companies need to answer next?MDCG 2025-10 | An In-Depth PMS Analysis from the Notified Body Perspective (Practical Guide for Manufacturers)After the MDCG 2025-10 update, what key points does your PMS still need to address?Based on the new MDCG guidance, what kind of PMS are regulators now truly expecting?Cost breakdown for initial NMPA registration in China for Class II and Class III devices: what really drives the gap?Beyond the fixed registration fees, have you quantified type testing costs, clinical costs, and audit preparation costs?ISO 15223 transition period confirmed: expect audit questionsThe FDA has granted a transition period for ISO 15223-1, but auditors will not wait. How should you address AMD1:2025? This article breaks down the risk points from an audit perspective and provides practical implementation solutions.Administrative Provisions on the Management of Export Sales Certificates for Medical Devices issued, effective May 1, 2026On December 25, the NMPA issued an announcement revising and releasing a new version of the Administrative Provisions on the Management of Export Sales Certificates for Medical Devices, effective May 1, 2026;Under the new MDR draft, can clinical evaluation still follow the old approach?Clinical Evaluation under the MDR Amendment Draft: Evolving Requirements, Unchanged FundamentalsNever falsify medical device registration documentsIn three real cases, three registration certificates were revoked. The NMPA and local medical products administrations have taken consecutive enforcement actions, sending a clear signal: medical device registration documents are formal legal documents and mustDraft update to EU MDR 2017/745: No 5-year validity limit for certificates?The draft update to EU MDR signals both “burden reduction + acceleration,” with direct implications for medical device registration, clinical evidence, and compliance costs. **This article compares the 2017 version with the latest draft clause by clause, distiA clinical investigation costing millions wasted: Why can EU clinical evaluation cause the entire effort to fall short?Clinical investigations and clinical evaluation should reinforce each other!Practical Guide to Drafting a PMCF Plan for CE Marking under EU MDRIs your PMCF Plan correctly prepared?6-month countdown: Mandatory EUDAMED use is approaching—essential reading for medical device companiesAll medical device companies preparing to enter the EU market must complete SRN, UDI, device registration, certificate registration, and related procedures in advance. To help you avoid common pitfalls, I have compiled a lean yet highly practical response checDon't Wait for the Deficiency Letter: Clinical Evaluation for (EU) 2025/2086—HTA→JSC→PICO→JCA End-to-End Process and Company Action ChecklistNew Clinical Evaluation Rules: Before One Wave Settles, Another Arrives—Adding Yet Another Compliance BurdenWho Owns the Clinical Evaluation Report (CER)? Stop Expecting One Person to Carry It AloneDo not treat the Clinical Evaluation Report as a document that anyone can write. Regulators may not prescribe a specific job title, but they do require a closed loop of multidisciplinary competence: coordination across regulatory/compliance, product, and cliniIn-Depth Analysis of ISO 18969 (Clinical Evaluation): Legislative/Standards-Development Intent and Compliance Implications for ManufacturersThe development of ISO 18969 will provide the global medical device industry with a more harmonized and systematic clinical evaluation framework, helping manufacturers and regulators reduce regulatory divergence and improve the safety and reliability of medicaNovember 9 Medical Device News UpdateSiemens expects tariff impact to double; Shenzhen Core Medical's STAR Market IPO application accepted; Olympus plans to cut about 2,000 jobs; GE HealthCare issues a Class II recall for patient monitors; Philips issues a Class II recall for medical X-ray systemWearable, Customizable, Wireless MRI Coils: An Engineering Innovation That Could Reshape the Coil EcosystemA Revolution in MR Coils: Wireless Wearable Coils Usher in a New Era of Clinical ApplicationsGlobal Medical Device Regulations, Registration, Quality, and Post-market Surveillance—Authoritative Websites and Database DirectoryAuthoritative Directory of Websites for Major Global Medical Device Regulatory Authorities, Registration Databases, QMS Standards, Adverse Event and Recall Platforms, Clinical Trial Registries, and Medical Literature Search ResourcesFDA Issues Draft Guidance on QMSR, Officially Effective as of 2026-02-02Global Regulatory Convergence, a Shift from Document Compliance to System Effectiveness, Digital Review and Least Burdensome Principles, and Lifecycle Quality GovernanceThree Major Waves in Clinical Compliance: From MDR to ISO 18969 to EU 2025/2086—How Should Clinical Evaluation Respond?MDR, ISO 18969, and EU 2025/2086 Are Jointly Transforming Clinical Evaluation from “Compliant Market Entry” to “Lifecycle Clinical Evidence and Compliance Management”FDA issues draft QMS regulations, effective from 2026-02-02Original WeChat link: https://mp.weixin.qq.com/s/CH3Ua__LxT1GOU1924LpiA The original article is currently unavailable for retrieval (it may have been deleted or access-restricted). To maintain catalog consistency, a placeholder article has been created for noMedical Device Good Manufacturing Practice (2025 Edition) - Corporate Response StrategiesThis table is based on the provisions of the new Medical Device Good Manufacturing Practice (2025 Edition), combined with a comparative analysis against the 2014 GMP version, and is applicable to QMS self-Medical Device News & Insights - November 4Summary of Corporate Response Strategies for the 2025 New Edition of Medical Device Good Manufacturing PracticeClinsota at the Hong Kong Forum, Focusing on EU Compliance for Medical DevicesClinsota appeared at the Hong Kong forum, highlighting key EU MDR compliance pitfalls and priorities while decoding clinical compliance for medical-device market access to the EU under MDRMedical Device News & Updates - November 3In October, the NMPA published a list of 8 products denied registration, covering key areas such as intracranial drug-eluting stents and X-ray CT. As regulatory scrutiny tightens, insufficient clinical evidence has become the primary barrier. Registration of 1Daily Medical Device News - November 2The NMPA issued 15 medical device standards, accelerating the implementation of AI and robotic technologies; Suzhou volume-based procurement is driving the rise of domestic manufacturers; companies such as Mindray and United Imaging delivered strong performancCE MDR Clinical Evaluation Plan (CEP): Key Points and TemplateThe success or failure of a Clinical Evaluation Report (CER) often depends on the quality of the Clinical Evaluation Plan (CEP).Preparing Clinical Evaluation for (EU) 2025/2086: the full HTA→JSC→PICO→JCA workflow and a company action checklistThe original text cannot be extracted at this time due to WeChat access restrictions; the original link has been retained.EU Medical Device Borderline and Classification Update - Borderline and Classification - V4The EU Medical Device Borderline and Classification Manual Has Been UpdatedDaily Medical Device Industry Updates - LatestGlobal Medical Device InsightsUnder EU MDR, What Are the “Starting Point” and “End Point” of Clinical Evaluation for the CER?Under EU MDR, Have You Correctly Defined the “Starting Point” and “End Point” of Clinical Evaluation for the CER?A Brief Discussion of the Equivalence Pathway in EU Clinical EvaluationThe original text cannot currently be extracted due to WeChat access restrictions; the original link has been retained.What Are the Opportunities and Challenges of MDR CER?Find out whether your device may also qualify for a clinical trial exemption.