NCC Medical Strengthens Global Market Readiness with Dual CE MDR Certification

A dual-entity, dual-notified-body milestone for our electrophysiology and intraoperative neuromonitoring portfolio

At NCC Medical, we believe international growth must be built on a disciplined foundation of quality, clinical evidence and regulatory compliance. In 2026, we reached an important milestone in that commitment: our Singapore subsidiary and Shanghai headquarters each obtained CE MDR certification following assessments by TÜV SÜD and DEKRA, respectively.

This achievement establishes a dual-entity, dual-notified-body compliance framework for our business. It reflects the work we have undertaken to align our product development, clinical evaluation, manufacturing and quality-management practices with the requirements applicable to the EU Medical Device Regulation (MDR) 

Two certifications, one integrated compliance strategy

In February 2026, our Singapore subsidiary completed a comprehensive assessment by TÜV SÜD. Our EEG, EMG and IONM product portfolio received CE MDR certification, supporting our ongoing access strategy for markets that recognize this regulatory framework.

In June 2026, our Shanghai headquarters achieved CE MDR certification for its core IONM products following DEKRA's on-site factory audit completed in April. This certification is especially meaningful to us because intraoperative neuromonitoring is used in high-stakes clinical environments where product reliability, traceability and risk control must be consistently demonstrated.

Together, these certifications create a complementary structure:

• Singapore + TÜV SÜD: CE MDR certification for our EEG, EMG and IONM portfolio.
• Shanghai + DEKRA: CE MDR certification for our core IONM products, supported by an on-site manufacturing audit.
• One NCC Medical standard: an integrated approach to quality, compliance and responsible global expansion.

Built through three years of system-wide preparation

These certifications are not isolated regulatory outcomes. They are the result of three years of sustained investment in a product lifecycle management system designed for demanding medical-device requirements.

Across our organization, we have strengthened the foundations that support safe and consistent product performance:

• Research and development: We apply risk-based design and development processes, follow the EN 60601 electrical safety standard, and maintain technical documentation that is traceable and audit-ready.
• Clinical evidence: We use structured clinical evaluation practices, including multicenter and prospective research approaches where applicable, to support assessment of product safety and clinical value.
• Manufacturing and quality: Our operations are supported by an ISO 13485:2016 quality-management system, clean manufacturing environments and process-based inspection controls.
• Electromagnetic compatibility: We have established an in-house EMC laboratory to address the complex electromagnetic environment of the operating room and support stable transmission of low-amplitude neurophysiological signals.

For us, compliance is not a document exercise. It is how we translate engineering discipline into confidence for clinicians, hospitals and partners.

Designed for the realities of the operating room

IONM systems must perform in environments where electromagnetic interference, workflow complexity and clinical expectations converge. Our engineering focus is therefore not limited to meeting requirements; it is centered on supporting dependable signal acquisition and transmission in real operating-room conditions.

By combining electrophysiology expertise with a rigorous quality framework, we continue to develop solutions that support clinicians across EEG, EMG and intraoperative neuromonitoring applications. The CE MDR certifications reinforce our ability to bring this work to international markets through a more mature and resilient compliance platform.

Advancing from Chinese innovation to a global medical technology brand

Our dual-certification framework connects the strengths of our Shanghai and Singapore entities. Shanghai remains a core base for research, development and manufacturing, while Singapore supports our international compliance and market-development strategy.

This model reflects the direction of NCC Medical: to build globally relevant medical technology through accountable innovation, robust quality systems and sustained investment in clinical and regulatory capability.

We are also progressing registration activities in additional international markets. Registrations have been completed in India, Brazil and Colombia, while registration work in South Korea, Australia and Indonesia is advancing in line with local regulatory processes. FDA registration activities are also underway.

Looking ahead

Receiving dual CE MDR certification is an important milestone, not an endpoint. We will continue to strengthen our quality-management capabilities, advance our electrophysiology and IONM technologies, and work with clinical institutions and distribution partners worldwide.

Our purpose remains clear: to provide safe, stable and intelligent neurophysiological monitoring and electrophysiology solutions that support better-informed clinical practice around the world.