What is CDSCO Registration?
The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority for pharmaceuticals, medical devices, IVD diagnostic reagents, and cosmetics in India. Under the Medical Device Rules (MDR), 2017, all medical devices are regulated under a risk-based classification system (Class A, B, C, D).
No foreign or domestic manufacturer can import, market, or sell regulated healthcare equipment or cosmetic formulations without obtaining an official Import License (Form MD-14/15) or Manufacturing License (Form MD-3/5/7/9) through the SUGAM online portal.
Authorized Indian Agent
Foreign manufacturers must appoint a licensed Indian Authorized Agent holding a valid Form 20B/21B wholesale drug license.
ISO 13485 Alignment
Full alignment with ISO 13485 Quality Management System and Plant Master File (PMF) & Device Master File (DMF).
CDSCO Risk-Based Classification
CDSCO classifies medical and IVD devices into 4 categories depending on patient risk level:
Low Risk Devices
Low-Moderate Risk Devices
Moderate-High Risk Devices
High Risk / Life Supporting
Technical Dossier Requirements
Lockene's regulatory affairs team prepares complete Plant & Device Master Files:
- Free Sale Certificate (FSC) / Certificate to Foreign Government (CFG).
- ISO 13485:2016 Quality Management Certificate.
- Device Master File (DMF) with Risk Management Report (ISO 14971).
- Plant Master File (PMF) describing production premises.
- Power of Attorney (PoA) in favor of the Authorized Indian Agent.
- Form 20B/21B Wholesale Drug License of Indian Importer.
- Clinical Evaluation Data & Biocompatibility studies.
- Instructions for Use (IFU) and primary packaging artwork.
CDSCO Licensing Lifecycle
Classification & Indian Agent Appointment
Classify medical device under Class A/B/C/D and execute notarized/apostilled Power of Attorney with Indian Authorized Agent.
DMF & PMF Technical Dossier Preparation
Compile Device Master File, Plant Master File, stability data, and clinical evaluation reports aligned with MDR 2017 standards.
SUGAM / cdscomdonline Portal Submission
Submit application form (MD-14 for Import / MD-3 or MD-7 for Manufacturing) with official government fees in Bharatkosh.
Technical Review & Query Response
Liaison directly with CDSCO Drug Inspectors and Subject Expert Committee (SEC) to address technical observations.
Grant of CDSCO License (Form MD-15)
Issuance of official MD-15 Import License (perpetual validity subject to retention fee payment every 5 years).
Frequently Asked Questions (CDSCO)
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