HB Receives EU MDR Certificate

Haier Biomedical Receives World's First EU MDR Certificate for Medical Low-Temperature Storage Equipment

Receiving the EU MDR certificate marks a significant milestone for Haier Biomedical, demonstrating that its medical low-temperature storage products meet international standards for safety, performance, and full lifecycle management. This achievement represents a new chapter in Haier Biomedical's globalization journey, setting a new benchmark for high-quality global expansion in the medical device industry.

EU MDR Certified: Where Quality and Technology Align with International Standards

In recent years, advancements in life sciences and biotechnology have driven growing demand for precise and professional storage solutions, supporting steady growth in the medical low-temperature storage market. Meanwhile, the EU MDR certification is a mandatory requirement for medical devices entering the EU market. Compared to other regulations, the MDR imposes significantly higher standards for product performance and safety, enforcing stricter requirements for pre-market clinical evaluations, clinical data collection, post-market surveillance, vigilance systems, and regulatory oversight.

As an industry leader, Haier Biomedical has consistently pursued independent technological innovation since its founding. As early as 2006, the company independently developed core technologies for low-temperature refrigeration in biomedical applications, achieving localized production of such equipment. In 2013, it was awarded the Second Prize of the National Science and Technology Progress Award.

In parallel with its technological advances, the company has also played a key role in shaping industry standards. It led the development of China's first national standard for low-temperature storage devices and is currently spearheading the world's first IEC international standard project for medical-grade low-temperature storage equipment. It is transitioning to a path of achieving technological breakthroughs to leading global standard-setting efforts. TÜV Rheinland, a globally recognized third-party organization specializing in testing, inspection, and certification, brings strong technical expertise and extensive experience in medical device certification. Products certified by TÜV Rheinland are widely recognized for their high quality and reliability.

In an unprecedented achievement for China, Haier Biomedical has successfully obtained EU MDR certification for medical low-temperature storage devices. The company passed the rigorous EU MDR audit after extensive preparations, including product testing, software evaluation, cybersecurity assessments, usability reviews, clinical evaluations, and the implementation of an MDR-compliant quality management system. Medical devices certified under the EU MDR enjoy broad international recognition, which can significantly streamline regulatory approvals in other overseas markets, including Southeast Asia, the Middle East, and Africa. This reduces the need for redundant testing and documentation and shortens the registration timeline, enabling companies to accelerate their entry into emerging markets.

Liu Zhanjie stated that obtaining EU MDR certification is a strong endorsement of Haier Biomedical's commitment to technological innovation and product excellence. He emphasized that this achievement plays a key role in accelerating the company's "Product + Solution" model for high-quality global expansion. Building on this milestone, the company aims to provide high-quality solutions to more healthcare institutions and research organizations worldwide, supporting the high-quality global expansion of China's medical device industry and contributing Chinese wisdom and strength to global health efforts.

Geng Wen stated that the MDR certification of Haier Biomedical's plasma freezers and blood bank refrigerators not only demonstrates the company's technological capabilities but also represents a major milestone for Chinese high-end medical equipment on the global stage. Looking ahead, TÜV Rheinland will continue to leverage its international expertise to support the global expansion of outstanding Chinese medical device products and technologies, helping them enter the EU market efficiently and in full compliance. He also expressed hope for continued collaboration with Haier Biomedical to help shape a brighter future for the global medical device industry.

Driving Internationalization Through Localized Strategies:

Pioneering a New "Product + Solution" Model for Global Expansion

Receiving the world's first EU MDR certificate for medical low-temperature storage equipment is just one of the key milestones in Haier Biomedical's broader globalization strategy. In an increasingly globalized market, product certification is crucial in ensuring product quality and regulatory compliance, serving as a "passport" to international markets.

To meet the diverse product certification requirements of different countries and regions, Haier Biomedical remains firmly committed to regulatory compliance while continuously advancing independent innovation, leveraging advanced technology and upholding high standards to accelerate the implementation of its "Product + Solution" model for global expansion.

As of the end of 2024, Haier Biomedical had obtained over 400 international certifications across its product portfolio, including more than 200 EU CE certifications, over 70 U.S. FDA approvals, more than 140 U.S. UL certifications, and 12 U.S. AABB certifications.

As Haier Biomedical continues its global expansion, the company recognizes that long-term, sustainable success relies not only on the hard power of technological innovation, but also on the continued development of soft power in its global operations. With a global perspective, Haier Biomedical is committed to building a user-centered market system that enhances its capabilities in user engagement, customization, and scenario-based solutions.

Adopting a "one country, one strategy" localization approach, the company is actively strengthening regional delivery and establishing localized service response systems. By setting up local operation centers that integrate product development, marketing, logistics, and after-sales service, Haier Biomedical is able to quickly gain insights into and respond to local user needs, marking a shift from traditional product exports to co-creating ecosystems as part of its globalization model.

Haier Biomedical has established long-term partnerships with nearly 80 international organizations, including the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF). Its products and solutions have been deployed in over 150 countries and regions, contributing to global health and wellness.

Haier Biomedical's receipt of the world's first MDR certificate for medical low-temperature storage equipment at the CMEF marks a significant milestone in the global expansion of China's medical device industry. Today, international growth has become a key driver for Chinese medical device companies to establish a second growth curve, serving as a crucial pathway for leading brands to achieve internationalization and globalization.

Looking to the future, Haier Biomedical will continue to focus on user needs, strengthen its innovation capabilities, and pursue a dual strategy of localization and globalization. This approach will pave the way for a more stable and expansive path to high-quality global expansion, driving progress in global life sciences and healthcare, improving global medical accessibility, and contributing to a better life for all.