HongChuang Medical Devices (Changzhou) Co., Ltd. has officially passed the rigorous audit conducted by Shanghai POSI Certification Co., Ltd. and been awarded the ISO 13485:2016 Quality Management System Certification for Medical Devices (Certificate No.: 381260122R0S). This milestone signifies that HongChuang Medical’s quality management system has met internationally recognized standards, laying a solid foundation for the company to deepen its presence in both domestic and global markets.

Internationally Recognized Certification, Demonstrating Quality Excellence

ISO 13485 is the quality management system standard specifically developed by the International Organization for Standardization (ISO) for the medical device industry. It is widely regarded as a core prerequisite for medical device regulation worldwide, considered the “gold standard” for assessing quality management capabilities in the sector. The certification requires enterprises to meet stringent regulatory requirements across the entire chain — from design and development, through manufacturing, to after-sales service.

This certification was conducted in accordance with GB/T 42061-2022 / ISO 13485:2016, covering the production and distribution of multiple core product lines at HongChuang Medical:

The certificate is valid from June 3, 2026 to June 2, 2029. Certificate information can be publicly verified on the official website of the Certification and Accreditation Administration of China (CNCA) at http://cx.cnca.cn.

Quality as the Foundation: Building Core Competitiveness

Quality management is the lifeline of any medical device enterprise. Since its founding, HongChuang Medical has placed the construction of its quality management system at the strategic core of corporate development, establishing comprehensive, traceable quality control mechanisms spanning raw material procurement, production process control, and finished product inspection.

Achieving ISO 13485 certification means that HongChuang Medical’s:

Product reliability has been validated by an authoritative international third-party certification body, opening critical pathways for products to enter global markets;

Production standardization meets regulatory-grade requirements, ensuring the safety and consistency of every instrument leaving the factory;

Management system has achieved a paradigm shift from “experience-driven” to “standards-driven,” providing institutional safeguards for the company’s scalable expansion.

Certification Empowers Global Strategy

Notably, the product scope covered by this certification explicitly includes an “export only” designation, signaling that HongChuang Medical is simultaneously positioning itself for overseas markets. Against the backdrop of rapid restructuring in the global medical device supply chain, ISO 13485 certification serves as the essential “passport” for Chinese medical device companies seeking international markets. Whether for European CE marking, U.S. FDA 510(k) registration, or market access across Southeast Asia, the Middle East, and other emerging markets, ISO 13485 system certification is a prerequisite.

This certification not only paves the way for HongChuang Medical’s core products — including ultrasonic scalpels and vessel sealers — to enter export markets, but also establishes the foundational system for pursuing additional international certifications and expanding its global client network.

Dual-Engine Strategy: Innovation Meets Quality

Quality system certification and technology patent innovation represent the two pillars of HongChuang Medical’s “dual-engine” corporate strategy. Previously, the company’s independently developed “Bipolar Vessel Sealing Surgical Instrument” was granted a national invention patent (ZL 2025 1 0094520.1), and a patent portfolio has been established around electrosurgical tissue sealing, multi-channel irrigation-suction control, and related technologies.

Technology innovation addresses the question of “can we do it”; the quality system addresses “can we consistently do it well.” Achieving ISO 13485 certification means that HongChuang Medical has not only broken through technically, but has also taken a decisive step in translating innovative成果 into stable, reliable, and compliant mass-produced products.

Rooted in Changzhou, Serving the World

From its founding in 2023 to achieving ISO 13485 certification in 2026, HongChuang Medical has completed a full closed loop — from product R&D and patent portfolio development to quality system certification — in under three years, demonstrating exceptional corporate execution and a clear strategic trajectory.

Looking ahead, HongChuang Medical will use this certification as a new starting point to continue deepening its quality management system, accelerate the commercialization and internationalization of its core products, and strive to become a trusted Chinese brand in the global minimally invasive surgical instrument industry.

About HongChuang Medical Devices (Changzhou) Co., Ltd.

Founded in 2023, HongChuang Medical Devices (Changzhou) Co., Ltd. is located in the Hutang Science and Technology Industrial Park, Wujin District, Changzhou City, Jiangsu Province. The company specializes in the R&D, manufacturing, and commercialization of Class II and Class III medical devices, with core products spanning electrosurgical instruments, vessel sealing systems, ultrasonic scalpel components, trocars, and minimally invasive surgical accessories.

Certification Details

Certification Standard: GB/T 42061-2022 / ISO 13485:2016

Certificate No.: 381260122R0S

Certification Body: Shanghai POSI Certification Co., Ltd.

Initial Issue Date: June 3, 2026

Valid Until: June 2, 2029

Verification Website: http://cx.cnca.cn