CDSCO
Central Drugs Standard Control Organization (India)
India
Last reviewed 2026-06-21
India's CDSCO regulates medical devices under the Medical Devices Rules 2017 (amended 2020). India uses a four-class system (A, B, C, D). India is the fastest-growing major medical device market globally, with increasing regulatory sophistication and domestic manufacturing emphasis.
DEVICE CLASSES
Class A, B, C, D
APPROVAL PATHWAY
CDSCO registration / import license
KEY REGULATORY FUNCTIONS
- ▸Medical device registration
- ▸Import license (Form MD-14)
- ▸Clinical investigation approval
- ▸Quality management system audit
- ▸Adverse event reporting
OFFICIAL WEBSITE
https://cdsco.gov.in →§ FAQ
What is CDSCO in India?
CDSCO (Central Drugs Standard Control Organization) is India's national regulatory authority for medical devices, operating under the Ministry of Health & Family Welfare. It regulates devices under the Medical Devices Rules 2017 (amended 2020) using a four-class system (A, B, C, D). India is the fastest-growing major medical device market globally.
How do I register medical devices in India with CDSCO?
Medical device registration in India requires: an import license (Form MD-14) for foreign-manufactured devices, appointment of an Authorized Indian Agent, submission of technical documentation including performance and safety data, and a manufacturing site audit for Class C and D devices. Class A and B devices follow a simplified registration path.
What are CDSCO device classification classes?
India uses a four-class risk-based system: Class A (lowest risk, e.g. tongue depressors), Class B (low-moderate risk, e.g. hypodermic needles), Class C (moderate-high risk, e.g. hemodialysis equipment), and Class D (highest risk, e.g. heart valves, implantable defibrillators). Classification follows the Medical Devices Rules 2017 schedule and is broadly aligned with GHTF/IMDRF recommendations.
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