CDSCO Registration & Import License (Medical Devices & IVDs)
Regulatory approvals, Class A/B/C/D classification, and MD-14/MD-15 import licensing under Medical Device Rules, 2017.
Overview
The Central Drugs Standard Control Organization (CDSCO), headed by the Drugs Controller General of India (DCGI) under the Ministry of Health and Family Welfare, enforces the Medical Device Rules, 2017 (MDR 2017) framed under the Drugs and Cosmetics Act, 1940. In India, all medical devices and in-vitro diagnostic (IVD) devices are regulated under a strict four-tier risk classification: Class A (Low risk), Class B (Low-moderate risk), Class C (Moderate-high risk), and Class D (High risk). Following the universal medical device notification mandate, no medical device can be imported, manufactured, or commercially distributed in India without formal CDSCO registration and licensing. For foreign manufacturers, obtaining an Import License requires appointing an Authorized Indian Agent (AIA) holding a valid wholesale drug license (Form 20B/21B), submitting comprehensive Device Master Files (DMF) and Plant Master Files (PMF), clinical evaluation data, and CE/ISO 13485 certificates. Marketing unlicensed medical devices constitutes a severe statutory offense leading to criminal prosecution, product bans, and warehouse seizures. JRC Legal’s regulatory affairs team manages seamless CDSCO SUGAM filings for global and domestic MedTech enterprises.
Scope of CDSCO Registration Service
Detailed compliance and filing scope managed by JRC corporate experts.
Documents Required for CDSCO Medical Device Licensing
Upload digital files during onboarding. No physical submissions needed.
Manufacturer & Indian Agent Records
- Power of Attorney on Form MD-26 appointing the Authorized Indian Agent (AIA)
- Valid Wholesale Drug License (Form 20B/21B) of the Authorized Indian Agent
- Free Sale Certificate (FSC) issued by the National Regulatory Authority of country of origin (US FDA, CE, TGA, Health Canada)
- Valid ISO 13485 Quality Management System Certificate of the manufacturing facility
Technical Master Dossiers (IMDRF Format)
- Plant Master File (PMF) detailing factory premises, cleanrooms, and sterilization systems
- Device Master File (DMF) containing product design, risk analysis (ISO 14971), and biocompatibility data
- Clinical evaluation reports, instructions for use (IFU), and packaging label artwork
Step-by-Step CDSCO Licensing Procedure
Our step-by-step advisory workflow.
Step 1: Classification & AIA Establishment
We determine exact risk classification (Class A to D) and execute the statutory Form MD-26 Power of Attorney with the Indian agent.
Step 2: Dossier Preparation (DMF & PMF)
Our regulatory team compiles the Device Master File and Plant Master File adhering to CDSCO technical checklists.
Step 3: Online Submission on SUGAM Portal (Form MD-14)
We submit the application on Form MD-14 along with requisite statutory government licensing fees in US Dollars.
Step 4: Technical Scrutiny & Expert Committee Review
CDSCO technical officers review the dossier. We draft responses to any Subject Expert Committee (SEC) or departmental queries.
Step 5: Grant of Form MD-15 Import License
The Drugs Controller General of India (DCGI) issues the official Form MD-15 Import License, unlocking commercial distribution.
Strategic Benefits of CDSCO Medical Device Licensing
Unlock India’s booming healthcare market while guaranteeing absolute regulatory compliance.
Lawful Market Access in India
Authorizes lawful commercial sale, hospital procurement, and distribution of regulated medical devices across India.
Smooth ICEGATE Customs Port Clearance
Mandatory Form MD-15 import license enables seamless customs clearance of foreign healthcare hardware without port detention.
Institutional Hospital & Tender Procurement
Government medical institutions (AIIMS, State Medical Services Corporations) strictly mandate CDSCO licenses for tender participation.
Protection from Criminal Penalties
Shields company leadership from stringent penal provisions under Chapter IV of the Drugs and Cosmetics Act, 1940.
Perpetual License Structure
Under reformed MDR 2017 rules, licenses remain valid in perpetuity subject to timely payment of statutory retention fees every 5 years.
Frequently Asked Questions
Helpful answers to common regulatory inquiries.
What is the risk-based classification of medical devices in India?▼
Under the Medical Device Rules, 2017, devices are categorized into four classes: Class A (Low risk, e.g., surgical dressings, alcohol swabs); Class B (Low-moderate risk, e.g., hypodermic needles, suction equipment); Class C (Moderate-high risk, e.g., hemodialysis catheters, bone fixation screws); and Class D (High risk, e.g., heart valves, coronary stents, implantable pacemakers).
Who can be an Authorized Indian Agent (AIA) for foreign medical manufacturers?▼
The AIA must be an Indian business entity holding a valid Wholesale Drug License (Form 20B / 21B) issued by the State Drugs Control Department, and must possess valid e-KYC credentials on the CDSCO SUGAM portal.
What is the validity period of a CDSCO Form MD-15 Import License?▼
Under Rule 38 of MDR 2017, an import license granted on Form MD-15 remains valid perpetually, provided the licensee pays the prescribed statutory license retention fee every 5 years from the date of issue.
What are the government fees for CDSCO medical device import licensing?▼
Official government fees for import license (Form MD-14/15) are: For Class A: USD 1,000 per manufacturing site + USD 50 per device; For Class B: USD 2,000 per site + USD 1,000 per device; For Class C/D: USD 3,000 per site + USD 1,500 per device.
Are predicate device clinical trials in India mandatory for all devices?▼
If the medical device has already been approved and marketed in recognized reference regulatory jurisdictions (such as the United States, European Union, United Kingdom, Canada, Australia, or Japan) and has a valid Free Sale Certificate, local clinical trials in India are generally waived.
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