Medical Device Registration

Origin

The need for device registration arose as medical technology advanced beyond simple instruments, necessitating specialized regulatory oversight distinct from pharmaceuticals. The modern system is rooted in national and international frameworks, such as the classification systems used by the FDA and NMPA, which categorize devices based on their risk level. The fundamental principle is to ensure that all medical technology is reliable and safe for human interaction.

Mechanism

The mechanism of registration depends heavily on the device’s classification, ranging from simple record-filing for low-risk devices to a full pre-market approval process for high-risk, life-sustaining technology. The submission must include engineering specifications, biocompatibility data, sterilization validation, and clinical performance data. For a hormone monitor, this means demonstrating the accuracy and precision of the sensor readings relative to the physiological gold standard.