Accelerating Global Expansion: NCC Medical (Shanghai) Secures CE Certification, Establishing Dual CE-Certified Operations in China and Singapore

In 2026, NCC Medical achieved a milestone breakthrough in its global compliance strategy. Its Singapore subsidiary and Shanghai headquarters successfully passed rigorous audits by TÜV SÜD and DEKRA, respectively, securing the prestigious CE MDR certifications. This accomplishment establishes a unique, collaborative certificate-holding framework driven by dual corporate entities and dual renowned notified bodies.

In February 2026, NCC Medical’s Singapore subsidiary smoothly passed a comprehensive audit by TÜV SÜD. Its full range of EEG (Electroencephalography), EMG (Electromyography), and IONM (Intraoperative Neuromonitoring) product lines successfully obtained CE MDR certification. This official accreditation grants market access to the premium European Union market for NCC Medical’s entire lineup of routine electrophysiology products.

In June 2026, NCC Medical’s Shanghai headquarters secured another heavyweight international credential. Following a successful on-site factory audit by DEKRA in April, the company's core IONM products officially received the CE MDR certificate issued by DEKRA. The finalization of this certification signifies that NCC Medical’s high-risk intraoperative monitoring products fully comply with the stringent regulatory requirements of the EU MDR, marking another solid step forward in the group's global expansion.

 The Significance of CE-MDR Certification

The CE marking is a mandatory conformity mark for products sold within the European Economic Area. For medical devices, compliance with the EU MDR (2017/745) represents one of the most stringent and authoritative regulatory standards worldwide. Obtaining MDR-based CE certification demonstrates that an enterprise’s quality management systems fully meet EU rigorous requirements for medical device safety, performance and traceability, serving as a critical passport to access the European medical device market.

Unique Advantages of the Dual CE-Certified System

With the newly acquired certification for its Shanghai headquarters complementing the existing CE qualification of its Singapore subsidiary, NCC has built independent and fully MDR-compliant quality management systems at both production and operation bases. Compared with a single certified facility, this dual-site layout delivers distinct competitive strengths:

• Dual Compliance Endorsement: Both bases have passed rigorous audits by an authoritative EU notified body, greatly reinforcing clients’ confidence in our product quality and regulatory compliance.

• Enhanced Supply Chain Resilience: We are able to offer customers flexible product delivery options from China and Singapore. This dual-supply model effectively mitigates risks arising from global supply chain fluctuations and ensures stable product supply.

Corporate Strength & Quality Management Philosophy

The completion of dual-site CE certification is a key milestone in NCC’s global development strategy, rather than a finishing line. Adhering to the core philosophy of "Compliance First, Quality Oriented", NCC applies international standards to the entire value chain, covering R&D and design, supply chain management, manufacturing, as well as after-sales services.

During the certification audit for the Shanghai site, DEKRA conducted a comprehensive review of our quality system documentation, on-site production control, change management, adverse event monitoring and other key procedures, confirming full alignment with all requirements of the EU MDR requirements.

Future Outlook

Leveraging the strengths of our dual CE-certified bases in China and Singapore, NCC will further accelerate market expansion across Europe, delivering more compliant, reliable and efficient products and services to global clients. Moving forward, we will continue to optimize our global quality management system in line with top-tier international standards, and promote high-quality Chinese medical electronic devices to the global marketplace.

NCC MEDICAL welcomes qualified distributors worldwide to join our global partnership network. As a trusted manufacturer specializing in Intraoperative Neurophysiological Monitoring (IONM), EEG, EMG, and related consumables, we provide innovative products, strong technical support, and consistent supply to help our partners grow.