Bayer Receives First Domestic Medical Device Registration Certificate in China, Accelerating Localization of Imaging Diagnostic Equipment

China Finance and Economics News, June 17 — Bayer announced today that its imaging diagnostics business, MEDRAD^®Stellant D-CE High-Pressure Injection System and Accessories Receive Medical Device Registration Certificate for Products Manufactured in China from the Beijing Municipal Drug Administration (“Beijing Drug Administration”).

This is the first time that Bayer has obtained a medical device registration certificate for products made in China, marking a key milestone in the localization of Bayer's medical device production. Subsequently, the localization of Bayer's imaging diagnostic equipment production will be further accelerated.

In September 2024, the Beijing Municipal Medical Products Administration included the localization production of Bayer's medical devices into project-based management, implementing various measures that significantly improved the first locally produced product of Bayer, MEDRAD.^®The efficiency and convenience throughout the Stellant D-CE process. With the support of the Beijing Institute for Medical Device Testing, the registration inspection cycle for the first Stellant D-CE high-pressure injection system and accessories was shortened to 1.5 months through pre-technical services, significantly accelerating the product's market launch.

Through the pre-registration evaluation service provided by the Beijing Medical Device Review and Inspection Center, the company achieved "zero supplementary review," significantly shortening the registration and market entry time for Bayer's first imported medical device to be transferred to production in China.

　　MEDRAD^®Stellant D-CE High-Pressure Injection System and Accessories are suitable for intravenously injecting contrast agents into the human body during diagnostic studies performed with computed tomography application systems (i.e., CT enhancement examinations) and contrast-enhanced mammography systems. The device's integrated information module workstation supports radiology department management, radiation quality control, and empowers departmental research activities.

Bayer Imaging Diagnostics President Andrew Ford stated that the Bayer Imaging Diagnostics medical device plant in Beijing has recently obtained GMP certification, marking another significant step towards Bayer's commitment to serving Chinese patients with the highest global quality standards. "We look forward to continuing to collaborate with our partners to enhance imaging diagnostics and improve patient care."

"Following the landing of Bayer's first imaging diagnostic medical device plant in Beijing E-Town, MEDRAD^®Stellant D-CE Obtains China Medical Registration Certificate, Marking Another Significant Milestone for Bayer Imaging Diagnosis.” Wendy Hu, General Manager of Bayer Imaging Diagnosis Business in China, stated, “We thank the Beijing municipal government for their policy support and excellent service, which have helped accelerate the localization process with ‘Beijing Speed.’ In recent years, Beijing has strongly supported the high-quality development of innovative pharmaceuticals, continuously optimized the business environment, and driven medical companies to respond more efficiently to market demands. We look forward to the localization of MEDRAD.^®"Stellant D-CE will benefit more patients in China sooner."

Data shows that as the first world-class life science company in Beijing's Economic and Technological Development Zone, Bayer settled in the development zone in 1995 and has the largest prescription drug packaging base in Beijing, which is also Bayer’s largest worldwide. In recent years, the production of more products has been transferred to Beijing. In September 2023, Bayer's first factory for imaging diagnostics medical devices in China was established in the development zone, aiming to better provide Chinese patients with high-quality imaging diagnostic power injectors and related consumables.