MDCE’s Global Achievements in Clinical Trial & Regulatory Affair

MDCE is proud to announce a series of global achievements, showcasing our expertise in driving innovation and delivering results in clinical research and regulatory support. From securing FDA Breakthrough Device Designation (BDD) for high-risk devices to successfully completing Post-Market Clinical Follow-up (PMCF) studies, First In Human (FIH) trials, and Multi-Regional Clinical Trials (MRCTs), our projects span across North America, Europe, and Asia-Pacific. These accomplishments reflect MDCE’s commitment to helping clients navigate complex global clinical trial and regulatory pathways, accelerating market access, and improving patient outcomes worldwide. As a trusted partner, MDCE consistently delivers impactful results, supporting medical device innovations on a global scale.

BDD成果速递
MDCE has successfully assisted 4 Chinese clients in obtaining FDA Breakthrough Device Designation (BDD), covering cardiovascular, orthopedic, and gastrointestinal fields. With 8 ongoing BDD projects, MDCE continues to support Chinese medical device companies in entering the global market, enhancing their competitiveness through accelerated approvals and FDA recognition.
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[Breaking News] As FDA Tightens Certification for Chinese Breakthrough Devices, MDCE Supports Innomed’s High-Quality Submission of Magnesium Alloy Cannulated Screw, Securing Another FDA Breakthrough Device Designation!
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[Breaking News] MDCE Successfully Completes EU Class III High-Risk Post-Market Clinical Follow-Up (PMCF) Trial for a Leading Chinese Publicly Listed Company and Advances to the Data Lock Phase!
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[Breaking News] MDCE Supports Tangji Medical in Securing Approval in Latvia, Paving the Way for the Launch of Its First-in-Human Study in Europe!
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[Breaking News] MDCE Successfully Supports Skycano’s SkyFlow® Intracranial Thrombectomy Stent in Achieving Its First Commercial Clinical Use in the Baltic Region!

MDCE’s Global Industry Participation

MDCE actively participates in global industry events, showcasing expertise in global clinical trials, global regulatory registrations, and global commercialization. Through keynote speeches, panel discussions, and workshops at international forums, our teams provide cutting-edge insights into clinical trial execution, regulatory pathways, and market strategies. These activities highlight MDCE’s commitment to empowering medical device companies worldwide. By fostering collaboration with global experts, regulators, and industry leaders, MDCE continues to lead the way in navigating the complexities of the international medical device landscape, driving success across North America, Europe, Asia-Pacific, and beyond.

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[Event Recap] The 2024 North Hongqiao International Medical Conference highlighted global medical innovation. MDCE, a leader in China's medical device globalization, shared strategic insights on overseas expansion, emphasizing compliance and market entry to drive global healthcare progress.
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[Event Recap] CIMDR 2024丨MDCE Provides Insights on Key MDR and FDA Clinical Trial Requirements, Empowering Chinese Companies to Go Global!
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[Event Recap] 2024 IHMD: A Recap of the 5th International High-End Medical Device Forum | MDCE Founder Deng Xiaoyu Delivers Three Keynote Speeches
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[Event Recap] Singapore Business Delegation Successfully Concludes丨Participating Companies Achieve Significant Gains, Promising Future Collaborations Ahead
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[Event Recap] Industry Experts Discuss Expanding to Russia & Eurasian Economic Union丨MDCE Medical Device Registration Seminar Successfully Concludes

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