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New CFDA Regulations on Device Clinical Trials
The China Food and Drug Administration (CFDA) has been changing how medical devices are regulated by expanding and updating their laws. They have released multiple draft documents which elaborate on the caliber of...
Reminder: UDI Implementation Due Date Approaching
The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical devices require UDIs....
Laws Regulating Mobile Health Apps
The growing significance of mobile health apps result in a need to ensure its proper regulation. Practitioners, patients, researchers and medical industries are all affected by mHealth apps. The digital health field is...
China has become the second largest medical device market in the world. Sustained economy, population growth and a burgeoning aging population makes China a lucrative market for foreign medical device and...
General Context UDI is a Unique Device Identifier in the form of a unique number or alphanumeric code. It consists of plain text and AIDC (only readable via machine) Issued by an FDA-accredited issuing agency. UDI is...