GA Health Awarded EU MDR Certification by DQS

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.

1. Regulatory Alignment: MDR compliance is mandatory for CE marking, allowing legal distribution of medical devices in the European Economic Area (EEA).
2. Stricter Oversight: The regulation increases scrutiny of technical documentation, clinical evaluation, post-market surveillance, and risk management.
3. 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:

1. EU MDR CE certification (conformity assessment)
2. ISO 13485 certification audits
3. 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

• ISO 13485 Certification
• MDSAP Certification
• MDR Certification
• ISO 13485 Auditor Training