GA Health Company Limited, headquartered in Hong Kong with affiliates in a few countries, is a manufacturer specializing in endoscopy-related medical devices, has successfully obtained EU MDR (Medical Device Regulation 2017/745) certification, issued by DQS, for a category of its endoscope accessories. This achievement marks a major milestone in GA Health’s commitment to product quality, regulatory compliance, and international market readiness under the latest European Union requirements for medical devices.
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GA Health Awarded EU MDR Certification by DQS
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About GA Health
GA Health develops and manufactures advanced solutions for infection prevention and workflow efficiency in endoscopy procedures. Its flagship product line, Andorate, includes a comprehensive range of endoscopic valves, tubing, cleaning adapters, and accessories—supporting the full endoscopy workflow from procedure to reprocessing and storage.
With a mission to provide innovative, reliable, and effective tools for healthcare professionals, GA Health serves global markets including Europe, North America, and Australasia. The company integrates continuous R&D, quality control, and user-focused design to help reduce infection risks and improve clinical outcomes in minimally invasive procedures.
What is EU MDR Certification and Why It Matters
The EU Medical Device Regulation (MDR 2017/745) sets out the strictest regulatory requirements globally for the design, manufacturing, and post-market control of medical devices. Replacing the former Medical Device Directive (MDD), MDR prioritizes device safety, clinical effectiveness, and traceability.
- Regulatory Alignment: MDR compliance is mandatory for CE marking, allowing legal distribution of medical devices in the European Economic Area (EEA).
- Stricter Oversight: The regulation increases scrutiny of technical documentation, clinical evaluation, post-market surveillance, and risk management.
- Global Confidence: MDR-certified manufacturers demonstrate a high standard of operational excellence, which enhances trust with healthcare providers and regulators worldwide.
The Value of MDR Certification for GA Health
- Enabling European Market Access
The MDR certification authorizes GA Health to legally place its devices on the EU market under the CE mark, reinforcing its expansion strategy in Europe’s regulated healthcare landscape.
- Aligning with Global Regulatory Expectations
As international demand for stringent compliance grows, MDR certification supports GA Health’s credibility and eligibility in competitive tenders, procurement frameworks, and distributor partnerships worldwide.
- Showcasing Quality System Maturity
MDR certification reflects the strength of GA Health’s ISO 13485-compliant quality management system, especially in areas like design control, technical documentation, and lifecycle risk management.
From Certification to Clinical Confidence
GA Health’s successful MDR certification by DQS, an officially designated Notified Body under Regulation (EU) 2017/745, confirms its ability to meet the highest regulatory benchmarks in the medical device industry. The rigorous conformity assessment—covering documentation, quality management, and product compliance—illustrates the company’s readiness to meet both regulatory and clinical expectations in Europe and beyond.
This milestone enables GA Health to better serve hospitals, clinics, and endoscopy professionals with validated, high-standard medical devices that support patient safety and procedural integrity.
MDR Certification Services by DQS HK
DQS is designated as a Notified Body (NB) under EU MDR 2017/745, providing full conformity assessment services to medical device manufacturers globally.
In the APAC region, DQS HK offers:
- EU MDR CE certification (conformity assessment)
- ISO 13485 certification audits
- Ongoing surveillance and recertification audits
With deep regulatory expertise and global recognition, DQS helps manufacturers demonstrate compliance, improve market readiness, and navigate the complexities of evolving medical device regulations.
Associated Services by DQS HK
Author
DQS Hong Kong
DQS – Leveraging Quality, Driving Success.
DQS empowers organizations worldwide to build trust, drive innovation, and achieve sustainable growth by certifying the future of business. Founded in 1985, DQS has grown into a global leader in the assessment and certification of management systems, with a team of 3,000 highly qualified auditors delivering over 130,000 audit days per year in more than 60 countries. Through internationally recognized certifications across 200+ standards, DQS helps businesses manage risks, ensure compliance, and unlock new opportunities in an evolving regulatory and business landscape.
Thinking beyond compliance, DQS is a trusted partner for digitalization, automation, and sustainability leadership. The company’s expertise covers a wide range of areas, spanning from cybersecurity and AI governance to ESG compliance, supply chain management, medical device safety, and future mobility, delivering real value to industries in their pursuit of resilient, sustainable, and intelligent systems. By leveraging advanced auditing methodologies, predictive analytics, and real-time insights, DQS supports organizations to future-proof their operations while demonstrating their commitment to excellence and responsible business practices.
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