India CDSCO Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Regulatory Framework
Regulatory Authority: CDSCO (Central Drugs Standard Control Organisation), under the Ministry of Health and Family Welfare. The Medical Device Division handles device regulation.
Key Legislation:
- Medical Devices Rules, 2017 (MDR 2017, amended 2020 and 2023)
- Drugs and Cosmetics Act, 1940 (parent legislation)
- Medical Device (Amendment) Rules, 2023: expanded regulatory scope
Classification: Risk-based, 4 classes:
- Class A (low risk) | Class B (low-medium risk) | Class C (medium-high risk) | Class D (high risk)
- Aligned with GHTF/IMDRF classification principles
Registration Pathway:
- Class A/B: Registration certificate via online portal (simplified)
- Class C/D: Import license with full technical review
- Appoint an Indian Authorized Agent for foreign manufacturers
- Submit application via CDSCO online portal (SUGAM)
- Manufacturing site inspection may be required for Class C/D
Key Requirements:
- Import License or Registration Certificate required before marketing
- Indian Authorized Agent mandatory for foreign manufacturers
- ISO 13485 certification required
- BIS (Bureau of Indian Standards) compliance for notified devices
- Clinical investigation data for Class C/D novel devices
- Labeling in English (Hindi labeling may be required for retail products)
- Whole Life Cycle approach to regulation
Current Key Guidance:
Latest Updates
No recent updates available. Please check back later.