GHTF Medical Device Classification
The Global Harmonization Task Force (GHTF) was an international organization comprised of regulatory authorities and industry representatives from various countries, established to promote harmonization of medical device regulations worldwide.
The GHTF has been succeeded by the International Medical Device Regulators Forum (IMDRF), which continues its work toward regulatory harmonization.The GHTF developed several guidance documents, including those related to medical device classification.
These documents aimed to provide guidance to regulatory authorities and industry stakeholders on harmonized approaches to classifying medical devices
The classification of medical devices into these classes was based on factors such as the intended use, duration of contact with the body, and potential risks associated with the device.
GHTF Medical Device Classification
Class I
Low-risk devices that are non-invasive and pose minimal risk to patients.
Examples include bandages, tongue depressors, and non-powered wheelchairs.
Class II
Medium-risk devices that may be invasive or pose a moderate risk to patients.
Examples include powered wheelchairs, infusion pumps, and surgical gloves.
Class III
High-risk devices that are invasive or pose significant risk to patients.
Examples include implantable pacemakers, heart valves, and deep brain stimulators.
Class IV
Reserved for certain specific devices that are life-supporting or life-sustaining and have the potential to cause serious harm or death if they fail. These devices are subject to the highest level of regulatory scrutiny.
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