The classification system categorizes medical devices and in vitro diagnostic (IVD) devices based on risk levels: Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk). It includes imaging equipment, surgical instruments, prosthetic implants, catheters, monitoring devices, and disposables, ensuring regulatory compliance and enhancing patient safety under the Medical Devices Rules, 2017 in India.
The Drugs Controller General (India), Directorate General of Health Services, issued multiple notices under the Medical Devices Rules, 2017, to classify newly notified medical devices.
The key notices include File No. 29/Misc/3/2017-DC (292) dated 15.05.2019, File No. 29/Misc/3/2018-DC (18) dated 16.08.2018, and File No. 29/Misc/3/2018-DC (85) dated 06.06.2018, which amended and updated previous classifications from 01.11.2017 and 06.06.2018.
The classifications were made under Rule 4, Sub-rule (1) of the Medical Devices Rules, 2017, categorizing devices into Class A (Low Risk), Class B (Moderate Risk), Class C (Moderate-High Risk), and Class D (High Risk).
Key medical devices classified include CT Scans, MRI, Defibrillators, X-ray Machines (Class C), Transcatheter Heart Valves, Carotid Stent Systems, etc. (Class D), Blood Pressure Monitors and Digital Thermometers (Class B), and Absorbent Cotton Wool (Class A).
The notice dated 06.06.2018 also deleted "Sterile Drapes" (S.N. 333) and upgraded risk classifications for Intra-Osseous Fixation Wire, Bone Wire, Bone Cap, etc. from Class B to Class C. These updates ensure regulatory compliance and risk-based classification for medical devices in India.