IVD & CDx Expertise
With continually evolving regulations, the regulatory landscape pertaining to IVD, especially CDx products in China is complex. Although NMPA becomes more harmonized with international standards, China’s market approval is still of great challenges for foreign IVD/CDx manufacturers. China Med Device (CMD) assists IVD and CDx manufacturers to comply with China regulations throughout the whole product life cycle. From preparing regulatory strategies to providing registration/renewal/modification submission and post-marketing surveillance (PMS) services, we deliver unparalleled expertise. With proactive interactions with regulatory offices as well as the clients, CMD will enable your success on China entry.