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Taiwan’s legislature passed the Medical Device Management Law, which separates the country’s regulation of medical devices from pharmaceutical products for the first time.
China’s National Medical Products Administration (NMPA) updated its clinical trial regulations for medical devices last month, designating eight device categories that require clinical trials. It also added new exemptions from clinical trial requirements, allowed conditional approval with limited clinical data and published guidelines on the use of real-world data (RWD).
The FDA slapped Henan Kangdi Medical Devices with a warning letter over repeat CGMP failures at its Zhoukou, Henan facility, including a lack of testing.