According to GHTF, what class of medical device would NOT require a premarket on-site inspection?

In the context of the Global Harmonization Task Force (GHTF), medical devices are classified into different categories based on the level of risk they pose to patients and users. Class A devices, being categorized as low-risk, have a relatively simpler regulatory pathway compared to higher-risk classes.

Consequently, Class A devices typically do not require a premarket on-site inspection because they are considered to present minimal risk. This means that the necessary regulatory assessments can often be satisfied through documentation and self-certification processes rather than extensive on-site evaluations which are customary for classes carrying higher risks.

In contrast, Classes B, C, and D consist of devices that pose moderate to high risks, necessitating more stringent regulatory oversight and assessments, including premarket inspections to evaluate quality systems and compliance with regulatory requirements before they can be marketed. Thus, Class A being the correct choice reflects the established regulatory framework that prioritizes resources according to risk levels associated with different types of medical devices.