Bayer Achieves New Milestone in Local Manufacturing with China NMPA Approval of MEDRAD® Mark 7 Arterion

Bayer announces that MEDRAD, under its medical imaging diagnostics business,^®On April 3, 2026, the Mark 7 Arterion High-Pressure Contrast Injection System officially received the registration certificate for domestically produced medical devices issued by the Beijing Medical Products Administration (hereinafter referred to as “Beijing MPA”), marking a new milestone in the localized production of Bayer’s diagnostic imaging equipment.

As one of the import-to-domestic production projects supported by the Beijing Municipal Medical Products Administration through project-based management, MEDRAD^®Mark 7 Arterion obtained the test report within 28 working days and completed the registration review and approval process in 8 working days with “zero deficiency letters,” accelerating the localization of this product.

This MEDRAD^®The approval of the domestic production of the Mark 7 Arterion High-Pressure Contrast Injection System actively responds to the National Medical Products Administration’s policy orientation of optimizing full-lifecycle regulation and supporting the innovative development of high-end medical devices. As an indispensable key device for contrast examinations and interventional diagnosis and treatment in the field of diagnostic imaging, MEDRAD^®Mark 7 Arterion is a key component of the high-end medical imaging industry chain. Its localized production and regulatory approval for market launch in Beijing will help foster the clustering and development of technologies, manufacturing capabilities, and applications related to high-end medical imaging equipment in the city.

Bayer MEDRAD^®In 1967, it launched the first controllable-flow high-pressure angiographic injection system with disposable syringes, pioneering its application in coronary interventional procedures. This device enables precise delivery of contrast media into target vessels, achieving clear vascular visualization under X-ray imaging, thereby laying a critical foundation for interventional diagnosis and treatment. After more than half a century of iterative upgrades, Bayer MEDRAD^®The Mark series of products has achieved extensive coverage across a wide range of interventional procedures, including oncology, neurology, cardiology, and peripheral vascular interventions. These solutions empower physicians to safely, precisely, and efficiently perform critical operations such as stent implantation, balloon angioplasty, and embolic agent delivery, thereby continuously advancing the field of interventional medicine toward greater precision and standardization.

In China, MEDRAD^®The Mark 7 Arterion High-Pressure Contrast Injection System, with its leading technology and stable performance, is safeguarding public health across 31 provinces, autonomous regions, and municipalities in China. MEDRAD, produced locally.^®The Mark 7 Arterion High-Pressure Contrast Injection System maintains consistency with the quality of imported devices while enhancing supply chain efficiency and market responsiveness, thereby better and more swiftly serving clinical needs in China.

“MEDRAD^®“The Mark 7 Arterion high-pressure contrast injection system has obtained the Chinese medical device registration certificate, marking a new milestone in the localization of Bayer’s diagnostic imaging equipment production,” said Hu Wenjing, General Manager of Greater China for Bayer’s Diagnostic Imaging Division. “In recent years, Beijing has vigorously promoted the high-quality development of the medical device industry, providing comprehensive empowerment to the sector in the city, enabling both ‘innovative breakthroughs’ and ‘local establishment.’ We look forward to the localized MEDRAD”^® Mark 7 Arterion to benefit more Chinese patients sooner.”

June 2025, MEDRAD^®The Stellant D-CE high-pressure injection system and its accessories have obtained the registration certificate for domestically produced medical devices issued by the Beijing Medical Products Administration, and Bayer’s Beijing factory has been awarded the Good Manufacturing Practice (GMP) certificate for medical device production. This marks Bayer’s first time obtaining both a registration certificate for domestically produced medical devices and a GMP certificate for medical devices.

Following MEDRAD^®Following the Stellant D-CE high-pressure injection system, which became Bayer’s first high-pressure injection system to transition from import to domestic production and successfully launch in the market, MEDRAD^®Mark 7 Arterion High-Pressure Injection System: Ten months later, as the second high-pressure injection system from Bayer to achieve localized production and market approval in China, it marks a transition in Bayer’s localization journey in the field of high-end diagnostic imaging equipment—from a breakthrough with a single product to a replicable and sustainable systematic stage. This further demonstrates Bayer’s long-term commitment to deepening its local presence and serving Chinese patients with high-quality innovative products.

As the first world-class life sciences company in the Beijing Economic-Technological Development Area (BDA), Bayer settled in the BDA in 1995 and established its largest global packaging base for prescription drugs in Beijing. In recent years, it has successively transferred the manufacturing of more products to Beijing. In September 2023, Bayer’s first medical imaging device manufacturing facility in China was launched in the BDA, aiming to better provide Chinese patients with high-quality power injectors and consumables for diagnostic imaging.