Abstract
Core Products — IONM, EEG, EMG — Receive International Certification
NCC Medical Sets Sail Globally, Achieving Key Milestone in Market Expansion
Shanghai NCC Medical Co., Ltd., located in the Shanghai Pudong International Medical Industry Park, successfully completed an on-site audit for CE MDR compliance conducted by TÜV SÜD on September 24, 2025. This rigorous assessment by the internationally recognized Notified Body marks a critical step toward obtaining CE MDR certification and paves the way for NCC Medical’s entry into high-end medical markets across the European Union, Singapore, and beyond.
To meet the stringent requirements of the EU Medical Device Regulation (MDR) for high-risk devices, NCC Medical has systematically enhanced its entire medical device lifecycle management system over the past three years — from R&D and production to delivery. This includes comprehensive improvements in technical documentation, clinical evaluation, risk management, and production control, ensuring full compliance with MDR’s general safety and performance requirements.
In the R&D phase, the company strictly adheres to EN 60601 standards and CE MDR requirements, implementing a risk-based design control process. From concept initiation to design changes, every stage undergoes formal review, verification, and validation, resulting in complete, traceable technical documentation that meets TÜV SÜD’s high standards for completeness and compliance.
For clinical validation, NCC Medical conducted multi-center, prospective clinical evaluation studies in accordance with CE MDR regulations. These studies systematically collected clinical data to demonstrate the products’ clinical benefits and manageable risks, providing robust evidence to support CE certification.
In quality control and manufacturing, the company has fully implemented a quality management system (QMS) compliant with ISO 13485:2016 and EU GMP standards. NCC Medical operates a Class 10,000 cleanroom production facility, with multi-level inspection procedures for incoming materials, in-process components, and finished products. Process validation and continuous monitoring are strictly enforced throughout production, ensuring consistent product reliability, performance, and compliance with TÜV SÜD’s audit criteria.
Notably, NCC Medical is one of the few companies globally capable of independently developing and manufacturing both professional neurophysiology equipment and compatible consumables.
The company has mastered core technologies in EEG, EMG, evoked potentials, and multifunctional neural monitoring systems. Through its subsidiary, Shanghai Handy Medical Instrument Co., Ltd., it independently designs and produces a full range of intraoperative neuromonitoring consumables, including:
Nerve stimulation electrodes
Recording electrodes
Cortical electrodes
Urological electrodes
Suction probes
EEG electrodes
Connection cables
From material selection and mold development to injection molding, circuit packaging, and final assembly, all key processes are under full in-house control. This integrated “equipment + consumables” model ensures optimal compatibility in signal interfaces, electrical parameters, and anti-interference performance.
NCC Medical conducts integrated system testing and compatibility verification early in R&D and performs system-level functional inspections before shipment. This approach prevents signal distortion or monitoring interruptions caused by incompatible third-party consumables, significantly enhancing intraoperative system stability and safety — a capability that received high recognition from the TÜV SÜD audit team.
To address electromagnetic interference challenges in complex operating room environments, NCC Medical has established a high-standard EMC anti-interference laboratory. This lab simulates real-world scenarios with multiple strong interference sources — such as high-frequency electrosurgical units and patient monitors — conducting full-condition immunity tests on its products.
Leveraging this platform, the R&D team continuously optimizes shielding structures, filter circuits, and differential amplification algorithms. As a result, NCC Medical’s devices can stably acquire microvolt-level neural signals even under extreme interference conditions.
Third-party testing has verified that NCC Medical’s products achieve Common Mode Rejection Ratio (CMRR) and transient interference suppression performance at internationally advanced levels. These key indicators are critical parameters assessed by TÜV SÜD under the EMC Directive 2014/30/EU and form the technical foundation for CE MDR certification.
In 2024, NCC Medical became the first domestic company to successfully upgrade its Intraoperative Neurophysiological Monitoring Equipment to Class III medical device registration under China’s NMPA, aligning with new national regulations.
This change reflects the NMPA’s updated classification policy, which now categorizes devices used for real-time intraoperative neurological monitoring — and directly influencing surgical decisions — as high-risk (Class III). This proactive move demonstrates NCC Medical’s alignment with the risk-based regulatory philosophy emphasized by CE MDR and strengthens its clinical evidence framework for future international submissions.
Since its founding, NCC Medical has upheld “Quality First” as a core principle. The company first achieved ISO 13485 certification in 2010 and has continuously improved its quality management system. In recent years, significant investments have been made to digitize and enhance the QMS, enabling end-to-end electronic traceability and real-time risk monitoring across design, procurement, production, and after-sales service.
“This CE MDR audit by TÜV SÜD is not only a comprehensive evaluation of our current system but also a catalyst for advancing our global, standardized, and lean operations,” said the Head of Quality Systems at NCC Medical. “We look forward to completing CE MDR certification and bringing China’s independently developed high-end electrophysiology solutions to clinicians and patients worldwide.”
Prior to this milestone, both Shanghai NCC Electronic Corp., Ltd. and its consumables subsidiary Shanghai Handy Medical Instrument Co., Ltd. obtained ISO 13485:2016 certification from DEKRA (Certificate No. 6162750), laying a solid foundation for international market access.
In June 2025, NCC Medical’s core product, the Cynapse IONM System (for Neurosurgery/Orthopedics), passed an on-site audit by Brazil’s INMETRO at its Shanghai Pudong facility and subsequently received ANVISA registration (Certificate No. 0989678253) in September 2025 — marking formal entry into South America’s high-end medical market.
Next, the Smart IONM System (for ENT surgeries) will undergo an INMETRO factory audit in Brazil. This product has already obtained registration from Colombia’s INVIMA (Certificate No. 2024DM-0029185) and is commercially deployed in the country.
Later this year, NCC Medical will host an on-site audit by Russian regulatory authorities, advancing its compliance strategy in the CIS region. Notably, the company has also supported its Indian partner in securing CDSCO registration (Certificate No.: MFG/MD/2024/000065) in June 2025 — a milestone in the “Intelligently Manufactured in China, Delivered Globally” cooperation model.
Meanwhile, local registration processes are accelerating across multiple regions, including South Korea, Indonesia, Malaysia, Mexico, Peru, Ecuador, and South Africa. This systematic effort establishes a robust global compliance framework spanning the Asia-Pacific, Latin America, Europe, and emerging markets, reinforcing the internationalization of high-end “Made in China” medical devices.
Founded in 1997, Shanghai NCC Medical Co., Ltd. is a leading developer and manufacturer of high-end medical devices for intraoperative neural monitoring, EEG, EMG, and evoked potential systems. With over 300 employees, its products are used in more than 5,000 medical institutions across China, including major tertiary hospitals and regional medical centers, and are increasingly expanding into international markets in Southeast Asia, Europe, the Americas, and Africa.
Recognized as a National-Level “Specialized, Sophisticated, Unique, and Innovative” Little Giant Enterprise by China’s Ministry of Industry and Information Technology, NCC Medical is committed to independent innovation and lean manufacturing. It has built a fully self-controlled supply chain — from core technology R&D to key component production.
Its subsidiary, Shanghai Handy Medical Instruments Co., Ltd., has also been recognized as a Shanghai Municipal “Little Giant” Enterprise, reinforcing NCC’s leadership in integrated equipment and consumables innovation.
The company places strong emphasis on technological advancement and clinical value. Its IONM systems and 256-channel Digital EEG System with Event-Related Potentials for auxiliary cognitive diagnosis have both been included in the Shanghai New-Excellence Medical Devices Catalog, reflecting authoritative recognition of their innovation, clinical necessity, and safety.
Leveraging its proprietary EMC anti-interference laboratory and dual production bases for equipment and consumables, NCC Medical continues to overcome surgical environment challenges, enhancing monitoring stability and reliability. In 2024, it led the industry by completing the Class III registration upgrade for its intraoperative neural monitoring system, proactively responding to national policies on high-risk device supervision.
Going forward, NCC Medical will continue to uphold its philosophy of “Innovation-Driven, Quality-Based” development, committed to advancing Chinese high-end medical devices on the global stage. With the successful TÜV SÜD CE MDR audit as a new milestone, the company is accelerating its international strategic planning to deliver safer, smarter, and more integrated neurophysiological solutions to clinicians and patients worldwide.
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