By Fineline Cube 
German giant Bayer AG (ETR: BAYN) announced that it has received marketing approval from the Beijing Municipal Medical Products Administration (Beijing MPA) for its MEDRAD Stellant D-CE high-pressure injection system and accessories. This marks Bayer’s first domestic medical device registration certificate in China and represents a crucial milestone in the localization of Bayer’s medical device production.
Significance and Future Plans
Bayer will further accelerate the localized production of its medical imaging equipment. This approval underscores the company’s commitment to adapting its medical device production to meet the specific needs of the Chinese market.
Product Application
The MEDRAD Stellant D-CE high-pressure injection system and accessories are designed for intravenous injection of contrast agents into the human body. They support diagnostic studies in computed tomography (CT-enhanced examinations) and mammography-enhanced imaging systems.
Localization Process
In September 2024, Beijing MPA incorporated Bayer’s medical device localization production into a project-based management system. This significantly improved the efficiency and convenience of the entire localization process for the MEDRAD Stellant D-CE. With the support of Beijing MPA and through preemptive technical services, the registration testing cycle for the first locally produced Stellant D-CE high-pressure injection system and accessories was shortened to just 1.5 months.-Fineline Info & Tech