At NCC Medical Group, quality is not merely a process—it is a foundational principle embedded in our corporate since our establishment in 1997. Our commitment ensures all products and operations consistently meet the most rigorous national and global standards for safety, efficacy, and traceability.
The NCC MEDICAL GROUP operates under a robust dual-entity regulatory framework, built on multiple ISO 13485 certifications, to ensure the highest standards of compliance and quality assurance
Certified QMS
ISO 13485 quality management system.
Process Control
Controlled production, inspection, and testing workflows.
Product Traceability
Traceable records for devices and consumables.
Compliance Documentation
Audit-ready documentation supporting regulated markets.
Our quality management system is backed by a comprehensive triple-certified system, providing unparalleled confidence and security to our global partners
ISO 13485 certification ensures our core neurological monitoring systems (IONM, EEG, EMG/EP) are produced to the highest global standards, with stringent adherence to EN 60601 series standards and risk-based Design Control throughout the R&D lifecycle.
A separate ISO 13485 certification guarantees that all vital accessories and electrodes adhere to the same rigorous benchmarks, ensuring optimal performance and patient safety through our unique vertical integration model.
Our Singapore-based subsidiary, EXCELLENT, holds a third ISO 13485 certification. As the appointed Legal Manufacturer, this ensures robust compliance, streamlined logistics, and unwavering supply chain control.
Our domestic compliance highlights our capacity for advanced device manufacturing and regulatory foresight
Our facilities and processes adhere to the strict requirements of the National Medical Products Administration (NMPA) and all relevant Good Manufacturing Practices (GMP). We fully comply with the NMPA's updated risk classification policies.
NCC Medical is certified to manufacture Class III Medical Devices—the highest-risk category. This distinction underscores our technical expertise and operational stability. Notably, only 9% of Chinese medical manufacturers (3,189 of 35,359) hold Class III production certification, based on public industry data as of June 2025.
We have comprehensively restructured our entire process chain to comply with the stringent EU MDR requirements, including complete technical documentation and multi‑center clinical evaluations. This demonstrates our proactive readiness for entering advanced markets.
FDA Clearance In Progress:
Key products are undergoing FDA 510(k) clearance for U.S. market entry.
Completed Localized Registrations:
Registered in Brazil, Colombia, and India; pursuing further registrations globally.
Our quality commitment is matched by our active global market authorization strategy
We have successfully secured essential market access approvals, including Brazil ANVISA/INMETRO and Colombia INVIMA, validating our products for the highly regulated LATAM region. We are actively pursuing localized registration in over [Insert Number of Countries] countries across APAC, Europe, and emerging markets.
Utilizing our specialized EMC Anti-Interference Laboratory , our products undergo rigorous testing to ensure stability and accuracy in complex surgical environments, meeting the demanding EMC Directive standards essential for global compliance.
NCC Medical is actively expanding its regulatory commitment to solidify its position as a trusted global supplier. Our compliance strategy focuses on anticipating advanced regulatory requirements and securing market access across all major economic zones.
Advanced Market Engagement (FDA & MDSAP):We are actively pursuing FDA market authorization and evaluating the MDSAP framework to ensure unified quality compliance for our core products in the US and multiple international jurisdictions.
Strategic Market Acceleration：We are rapidly accelerating market clearance in high-standard territories like Australia (TGA) and APAC (K-GMP).
For all detailed compliance documents (ISO, CE, NMPA), please contact our Regulatory Affairs Team: [email protected]
Copyright © NCC Medical Co., Ltd. - Privacy policy
EN