What is a Medical Device?
The definition of a medical device in India under the Drugs and Cosmetics Act 1940 and Medical Devices Rules 2017, including examples and classification implications.
What is Not a Medical Device?
Articles excluded from the definition of a medical device under India's Medical Devices Rules 2017.
D&C Act §3(b) — The Legal Definition
Full text and analysis of the medical device definition in Section 3(b) of the Drugs and Cosmetics Act 1940 as amended.
CDSCO vs State Licensing Authority — Who Regulates?
Understanding the split between CDSCO (central) and State Licensing Authorities (SLA) in India's medical device regulatory framework.
Regulatory Framework Overview
An overview of India's medical device regulatory framework, including the D&C Act, MDR 2017, CDSCO, and the SUGAM portal.
Key Roles and Responsibilities
Who is responsible for what in India's medical device regulatory framework — manufacturers, IAR, importers, distributors, and notified labs.
Lifecycle of a Medical Device in India
The full regulatory lifecycle of a medical device in India, from design and development through import/manufacture, post-market surveillance, and end of life.
Phased Implementation & Transition History
The history of how India's Medical Devices Rules 2017 were implemented in phases, with progressive expansion of notified device categories.
Glossary of Key Terms
Definitions of key regulatory terms used in India's Medical Devices Rules 2017 and CDSCO framework.