NCC Global — CE MDR Certification Marks a New Milestone in Global Growth

     Shanghai, November 6, 2025 — Since the launch of its EU MDR (Draft) compliance program in 2022, NCC GROUP has achieved a major breakthrough in its global expansion strategy.

     Through three international entities — NCC MEDICAL (Mainland China), NCC MEDICAL (HK), and NCC Singapore — NCC Group has established a fully integrated “R&D–Regulatory–Sales” global operation system, providing partners worldwide with efficient and localized service and support.

     Recently, NCC Singapore achieved a significant milestone: its EEG (Electroencephalography), EMG (Electromyography), and IONM (Intraoperative Neuromonitoring) product lines have successfully obtained the CE MDR Certificate of Conformity (Draft) issued by TÜV Rheinland, certificate number G15 118094 (NCC MEDICAL).

     This achievement not only marks NCC’s formal entry into the EU’s latest regulatory framework but also lays a solid foundation for the company’s broader presence in the European high-end medical device market.

     NCC GROUP extends its sincere appreciation to the Singapore team for their outstanding dedication and efficient execution throughout the registration process, to Singapore’s regulatory authorities for their strong support in facilitating the device access, and to TÜV Rheinland for its professional guidance and rigorous evaluation during certification.

     This milestone represents a shared success built on trust, collaboration, and excellence across teams and partners.

     Meanwhile, the CE MDR registration led by Shanghai NCC Electrical Co., Ltd. is also progressing steadily and is currently in the critical audit phase with DEKRA Certification GmbH.

     Upon completion, NCC will further strengthen its dual-track regulatory capability, enabling synergy and mutual support between its China headquarters and overseas subsidiaries — a key step toward sustainable global expansion.

     To celebrate this milestone and express our gratitude to global partners for their long-term trust and support, NCC is launching a limited-time appreciation program:

From now until March 31, 2026, 

customers who purchase designated NCC EEG, EMG, or IONM systems 

will receive free matching consumables of equivalent value.

     This “Buy Equipment, Get Consumables” campaign aims to lower initial investment costs for partners, accelerate clinical adoption, and share the benefits of MDR compliance.

“We understand how closely our global distributors have followed NCC’s MDR progress,” said an NCC representative.

“This certification milestone demonstrates not only the technical excellence and quality of our products but also our unwavering commitment to global expansion and localized support. Moving forward, NCC will leverage its three overseas platforms to accelerate regional partnerships and seize growth opportunities in neurophysiology and intraoperative neuromonitoring.”

      As CE MDR certification continues to advance, NCC GROUP is officially launching its Global Partner Recruitment Program, opening regional cooperation opportunities across Europe, Asia-Pacific, the Middle East, and the Americas.

     We sincerely invite partners, healthcare institutions, and professionals in the field of neurophysiology to visit us at MEDICA 2025, held in Düsseldorf, Germany, and meet us in Hall 9, Booth B33-2 —to explore collaboration, expand markets, and bring advanced neuro-monitoring technologies to patients worldwide.

About NCC Medical Co.,Ltd

     For 28 years, NCC Medical has focused on tackling key challenges in electrophysiological technology and developing related products. Adhering to the core value of "Commitment,Sincerity,Integrity," the company has continuously launched high-end electrophysiological equipment with independent intellectual property rights, driving the development of the electrophysiology industry. Its independently developed product—the first domestically made neurostimulation monitor specifically designed for intraoperative use in orthopedics and neurosurgery—has achieved a major breakthrough in domestic manufacturing and broken the barrier of reliance on imported equipment. Looking ahead, in the field of intraoperative electrophysiology, NCC Medical aims to strengthen industry-academia-research cooperation with clinical institutions, advance the development of cutting-edge technologies in this field, and provide higher-quality services for patients.

     As a "National-level Specialized, Refined, Differential, and Innovative Little Giant Enterprise" recognized by the Ministry of Industry and Information Technology, NCC Medical has always adhered to independent innovation and lean manufacturing, and built a full-chain independent and controllable system covering core technology R&D to key component production. The company's consumables subsidiary, Shanghai Yingshou Medical Device Co., Ltd., has also been awarded the title of "Shanghai Municipal-level Specialized, Refined, Differential, and Innovative Little Giant Enterprise", which further strengthens the company's leading advantages in the collaborative innovation of equipment and consumables.

     NCC Medical attaches great importance to technological innovation and clinical value. Its independently developed intraoperative  neuromonitoring and 256 high-channel event-related potential digital EEG capable of assisting cognitive diagnosis have both been included in the Shanghai Innovative Medical Devices Catalog . This marks that the products have obtained authoritative recognition in terms of technological advancement, clinical urgency, and quality and safety standards.