基于风险的医疗器械分类

The risk-based classification system is a cornerstone of modern 医疗器械 regulation worldwide. It acknowledges that a one-size-fits-all regulatory approach is inefficient and potentially unsafe. Instead of subjecting every device to the most stringent review, regulators tailor their oversight to the potential for harm. The classification is determined by factors such as the device’s intended use, duration of contact with the body, degree of invasiveness, and whether it delivers energy or has a biological effect.

For example, in the United States, Class I devices (e.g., elastic bandages) are subject to ‘General Controls,’ which include registration and proper labeling. Class II devices (e.g., infusion pumps, powered wheelchairs) require ‘Special Controls’ in addition to general ones, often including performance standards and premarket notification (510(k)). The highest risk category, Class III (e.g., implantable pacemakers, heart valves), requires the most rigorous ‘Premarket Approval’ (PMA), which involves submitting extensive clinical data to prove safety and effectiveness.

This tiered system allows regulatory agencies to focus their resources on devices that pose the greatest risk, while facilitating market access for lower-risk innovations. The concept was foundational to the US Medical Device Amendments of 1976 and has been adopted and adapted by regulatory bodies globally, forming the basis for frameworks like the European Union’s Medical Device Regulation (MDR).