How Classification Works
How medical device classification works in India under the Medical Devices Rules 2017, including the four risk classes and the classification criteria.
Class A · B · C · D — Overview
Detailed overview of India's four medical device risk classes under MDR 2017 with examples, licensing pathways, and GMP requirements for each.
IVD Classification
Classification of in vitro diagnostic devices in India under Schedule II of the Medical Devices Rules 2017.
SaMD & Standalone Software Classification
How Software as a Medical Device (SaMD) is classified in India, including IMDRF principles adopted by CDSCO.
Borderline & Combination Products
How to handle products on the borderline between medical devices and drugs, cosmetics, or food in India.
Notified Device Categories — Schedule I & II
The categories of medical devices and IVDs currently notified under Schedule I and Schedule II of the Medical Devices Rules 2017, subject to CDSCO licensing.