National Medical Products Administration

The National Medical Products Administration (NMPA, 国家药品监督管理局) is China's national regulatory authority for pharmaceuticals and medical devices, serving as the counterpart to the U.S. Food and Drug Administration (FDA). Per a 高榕创投 report, it approves clinical trials and product registrations for drugs and devices—such as CASI's CS0159 FXR agonist for primary sclerosing cholangitis, which received NMPA clinical-trial approval in January 2022 . In the medical-device space, it has cleared multiple products covered in elsewhere's corpus, including 沃比医疗's Esperance® 6F aspiration catheter (reportedly the first device globally to hold both NMPA and FDA approvals simultaneously), 帕母医疗's PADN catheter (the first China-originated, first-in-class pulmonary arterial hypertension device), and 康诺思腾's Sentire思腾® laparoscopic surgical robot . The agency also oversees AI-enabled healthcare tools, as with 数坤科技's coronary CT-FFR software, which obtained a Class III medical-device registration certificate in February 2023 . Its regulatory decisions are frequently cited alongside FDA approvals as milestones in Chinese companies' domestic commercialization and global expansion strategies.