The Medical Devices Rules, 2017, introduced by the Central Drugs Standard Control Organization (CDSCO), have adopted a risk-based classification system for medical devices, which is in line with the guidelines of the Global Harmonization Task Force (GHTF). This system categorizes medical devices into four classes based on the potential risk associated with their use: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk).
This system categorizes medical devices into four classes based on the potential risk associated with their use: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk).
- Class A (Low Risk):
- Class A devices are non-invasive and generally do not come into contact with the patient or contact only the intact skin.
- Examples include devices like bandages, surgical masks, examination gloves, and tongue depressors.
- Class B (Low-Moderate Risk):
- Class B devices are non-invasive but come into contact with intact mucous membranes.
- Examples include devices like hypodermic needles, suction equipment, and aerosol nebulizers.
- Class C (Moderate-High Risk):
- Class C devices are invasive, entering the body through a body orifice or making contact with the internal body fluid path.
- Examples include devices like bone fixation implants, heart valves, and intraocular lenses.
- Class D (High Risk):
- Class D devices are invasive and come into contact with the cardiovascular system, and central nervous system, or are intended for life support or sustenance.
- Examples include devices like pacemakers, defibrillators, and implantable stents.
The classification is based on several factors, including the degree of invasiveness, duration of use, potential for local or systemic adverse effects, and the risk associated with the device’s intended use.
In addition to this risk-based classification, medical devices in India are further categorized as either surgical or non-surgical devices based on their invasiveness. Surgical devices are those that penetrate the body through a body orifice or break the skin barrier, while non-surgical devices do not penetrate the body or break the skin barrier.
The risk-based classification system helps regulatory authorities establish appropriate levels of regulatory control and oversight, with higher-risk devices requiring more stringent pre-market and post-market requirements. This classification also aids in determining the conformity assessment procedures, labeling requirements, and post-market surveillance activities for medical devices in India.
It is important for manufacturers and importers of medical devices in India to understand and comply with the risk-based classification system and the associated regulatory requirements to ensure the safety and efficacy of their products.
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