GCBiomed Demonstrates Global Compliance with ISO 13485 Certification and Successful MDSAP Audit, Accelerating International Market Access

Class III Absorbable Devices Advance Toward EU MDR and US FDA 510(k) Review in Parallel

Building the Quality Foundation of Class III Absorbable Devices on Leading International Standards 

CHANGZHOU, China — Greatchina Biomedical Technology (Jiangsu) Co., Ltd. ("GCBiomed", gcbiomed.com), a leading developer of advanced biomedical absorbable materials and related surgical devices, is pleased to announce that it has successfully passed a rigorous, integrated QMS audit conducted by the BSI. The Company has been formally awarded the ISO 13485:2016 certification and has successfully satisfied all audit requirements under MDSAP.

This demanding assessment was executed as a combined on-site audit, aligned with the ongoing EU MDR registration review of the Company’s multiple Class III absorbable product lines. Passing this single, comprehensive assessment in one go represents a critical regulatory milestone. It confirms that GCBiomed’s capabilities in design and development, risk management, and full product lifecycle control are fully aligned with the most stringent global regulatory expectations.

From "Product Globalization" to "System Globalization": Laying the Cornerstone for Global Expansion

For a high-risk medical device manufacturer, long-term competitiveness in the international arena is built not only on cutting-edge product innovation, but on a robust compliance moat.

· High-Standard Systems in Place: The successful implementation of the ISO 13485 framework and MDSAP requirements validates GCBiomed’s capability to operate an efficient quality system across diverse and complex multi-national regulatory environments.

· A Complete, End-to-End Compliance Loop: Capitalizing on these system achievements, the Company is establishing a powerful strategic chain: International QMS Alignment → International Regulatory Clearance → Robust Clinical Evidence → Global Market Access. This foundational alignment effectively lowers entry barriers for leading international distributors and tier-one healthcare institutions.

Building a Portfolio of High-Risk Absorbable Devices

Drawing on 30 years of accumulated material technology expertise, GCBiomed is accelerating the clinical translation of its advanced bio-polymer innovations worldwide:

· GClipX® Absorbable Ligating Clips: Built on our proprietary medical absorbable polymer platform, these clips deliver reliable, secure tissue closure with progressive, predictable degradation. They meet exact clinical performance needs while minimizing the infection and imaging risks associated with permanent foreign-body retention.

· PPDO Absorbable Surgical Sutures: Engineered to provide superior tissue anchoring and durable wound support tailored to a wide range of challenging surgical indications.

Beyond these flagship offerings, several pipeline Class III absorbable surgical innovations are currently undergoing advanced development.

Next Stop: "GCBiomed" as a Trusted Global Brand

This dual QMS milestone serves as a fresh launchpad as GCBiomed expands into premier healthcare markets across Europe, North America, the Middle East, Latin America, and Russian-speaking regions.

The execution of GCBiomed’s global market access roadmap is moving forward seamlessly:

· ✅ ISO 13485 — Certified

· ✅ MDSAP — Audit Requirements Satisfied / Compliant

· ⏳ EU MDR — Under Assessment (Combined QMS audit successfully completed)

· ⏳ US FDA 510(k) — Under Review

Our international distribution channel network is growing rapidly. Looking ahead, GCBiomed remains committed to deepening global clinical collaborations and strengthening our international commercial partnerships. By combining high-standard quality systems with robust clinical evidence, we aim to bring China’s smart-manufactured surgical innovations to a wider global stage—fulfilling our medical mission through foundational material innovation.

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Media & Business Inquiries:

Greatchina Biomedical Technology (Jiangsu) Co., Ltd.

Room 1, Building 13, No.3 Hanshan Road, Xuejia Town, Xinbei District, Changzhou, Jiangsu 213125, China

Email: info@gcbiomed.com | Tel: +86-519-88667019