CDSCO Medical Devices Manufacturing & Import Licensing
Medical Devices Rules (MDR 2017) | Class A, B, C, D Device Classification | State SLA & Central CDSCO | Form MD-5 / MD-9 / MD-14
Manufacture or import medical devices, surgical equipment, diagnostics, and IVDs legally in India with senior biomedical regulatory lawyers and CDSCO specialists. We manage device classification, ISO 13485 QMS validation, Device Master File (DMF) and Plant Master File (PMF) compilation, and secure manufacturing and import licenses from State Licensing Authorities and CDSCO HQ.
Under the Medical Devices Rules 2017 (MDR 2017) notified under the Drugs and Cosmetics Act 1940, all medical devices and In-Vitro Diagnostic (IVD) devices are regulated under a risk-based classification (Class A: Low Risk, Class B: Low-Moderate Risk, Class C: Moderate-High Risk, Class D: High Risk). No device can be manufactured or imported without a valid CDSCO/SLA license.
- Class A & B Manufacturing License in Form MD-5 / Form MD-6 from State Licensing Authority
- Class C & D Manufacturing License in Form MD-9 / Form MD-10 from Central CDSCO HQ (New Delhi)
- Medical Device Import License in Form MD-14 / Form MD-15 for overseas medical device manufacturers
- Complete compilation of Device Master File (DMF), Plant Master File (PMF), and Risk Management (ISO 14971)
Why Choose CDSCO License (Medical Devices Manufacturing & Import MD-5 / MD-9 / MD-14)?
Manufacturing, importing, or distributing unregistered medical devices in India is a serious criminal offense under the Drugs and Cosmetics Act, resulting in immediate customs seizure, heavy financial penalties, and up to 5 years imprisonment.
Manufacture Class A, B, C, D Medical Devices
Legally manufacture surgical consumables, orthopedic implants, diagnostic kits, imaging equipment, and hospital machinery.
Import Global Medical Devices into India (Form MD-14)
Act as the Authorized Indian Agent (AIA) to legally import and distribute foreign medical device brands across India.
Export Medical Devices Worldwide with Free Sale Certificates
Obtain Certificate of Free Sale (CFS) from CDSCO enabling global exports to ASEAN, Middle East, Europe, and Africa.
Hospital Empanelment & Government GeM Tenders
Fulfill mandatory CDSCO registration criteria required by AIIMS, railway hospitals, defense procurement, and private hospital chains.
100% ISO 13485 QMS & MDR 2017 Compliance
Align your facility with international cleanroom standards, sterilization validation, and bioburden controls.
Turnkey CDSCO Sugam Handholding
Our regulatory team handles Notified Body audits, DMF technical dossier compilation, and central CDSCO approvals.
Comprehensive CDSCO License (Medical Devices Manufacturing & Import MD-5 / MD-9 / MD-14) Offerings
Our CDSCO advisory covers risk classification, technical file preparation, and state/central portal licensing.
1. Risk-Based Medical Device Classification
- Class A (Low Risk): Cotton, non-invasive surgical instruments, manual wheelchairs, IVD general instruments
- Class B (Low-Moderate Risk): Hypodermic needles, suction catheters, BP monitors, ultrasound probes
- Class C (Moderate-High Risk): Hemodialysis machines, anesthesia workstations, bone screws, contact lenses
- Class D (High Risk): Cardiac stents, orthopedic knee/hip implants, heart valves, HIV/HCV diagnostic kits
2. Domestic Manufacturing Licensing (MD-5 & MD-9)
- Class A & B: Filing Form MD-3 on CDSCO portal for State Licensing Authority (SLA) grant of Form MD-5 license
- Class C & D: Filing Form MD-7 on CDSCO portal for Central Licensing Authority (CLA) grant of Form MD-9 license
- Coordinating Notified Body third-party audit and joint technical inspection by CDSCO Medical Device Officers
- Compilation of Plant Master File (PMF), Device Master File (DMF), and Sterilization Validation files
3. Medical Device Import Licensing (Form MD-14)
- Filing application in Form MD-14 on CDSCO Sugam portal through an Authorized Indian Agent (AIA)
- Executing Power of Attorney (PoA) and Wholesale Drug License (Form 20B/21B) verification
- Submitting overseas Free Sale Certificate (FSC), ISO 13485 certificate, and Full Technical Dossier
- Issuance of official Medical Device Import License in Form MD-15 valid for 5 years
4. Post-Market Surveillance & Materiovigilance
- Setting up Post-Market Surveillance (PMS) plans and Periodic Safety Update Reports (PSUR)
- Reporting adverse medical device events under Materiovigilance Programme of India (MvPI)
- Unique Device Identification (UDI) barcoding and packaging labeling compliance
- Endorsement of new device models, accessories, and factory site change notifications
Step-by-Step CDSCO License (Medical Devices Manufacturing & Import MD-5 / MD-9 / MD-14) Execution Process
Step 1: Device Classification & Gap Analysis
Classifying product under Class A/B/C/D, reviewing ISO 13485 QMS status, and establishing testing requirements.
Step 2: DMF & PMF Technical Dossier Compilation
Compiling Device Master File (DMF), Plant Master File (PMF), Risk Analysis (ISO 14971), and biocompatibility test reports.
Step 3: Online CDSCO Portal Submission
Submitting electronic application on CDSCO Sugam portal / State SLA portal with statutory government fees.
Step 4: Notified Body Audit & Joint Inspection
Accredited Notified Body and CDSCO Medical Device Officers conduct on-site physical cleanroom inspection.
Step 5: Grant of CDSCO License (MD-5 / MD-9 / MD-15)
Licensing authority issues official Medical Device Manufacturing / Import License valid for 5 years.
Documents Required for CDSCO License (Medical Devices Manufacturing & Import MD-5 / MD-9 / MD-14)
Manufacturing Facility & Corporate Dossier
- Entity Registration: Company Incorporation Certificate, MOA/AOA, GSTIN, PAN
- Approved Factory Blueprint: Plant layout drawing showing cleanroom zoning (ISO Class 7/8), airlocks, and testing labs
- Pollution & Factory Clearances: State Pollution Control Board Consent to Operate (CTO) and Factory License
- ISO 13485 Certificate: Accredited ISO 13485:2016 Quality Management System Certificate
Device Master File (DMF) & Technical Dossier
- Device Master File (DMF): Detailed product design, material specifications, Bill of Materials (BOM), and intended use
- Plant Master File (PMF): Comprehensive manufacturing capacity, cleanroom HVAC, and equipment validation description
- Risk Management File: ISO 14971 risk analysis, hazard identification, and residual risk evaluation report
- Biocompatibility Test Reports: ISO 10993 cytotoxicity, sensitization, irritation, and systemic toxicity test certificates
Testing & Performance Validation Files
- Sterilization Validation: Ethylene Oxide (EtO) / Gamma sterilization validation report per ISO 11135/11137
- Real-Time Stability Data: Product shelf-life and packaging integrity accelerated stability test reports
- Clinical Evaluation Report: Clinical literature review and safety equivalence data per MDR 2017
- Electrical Safety Reports: IEC 60601-1 electrical safety and EMC test reports (for powered medical devices)
Import Specific Documents (For Form MD-14)
- Power of Attorney (PoA): Legal Power of Attorney executed by foreign manufacturer appointing Authorized Indian Agent
- Free Sale Certificate (FSC): Certificate of Free Sale issued by National Regulatory Authority of country of origin (US FDA, CE, TGA)
- Overseas Plant ISO 13485: Valid ISO 13485 certificate of the overseas manufacturing facility
- Wholesale Drug License (20B/21B): Valid wholesale license of the Indian importer/agent
Why Choose Lawful Journey?
Senior CS & Advocate Leadership
Direct supervision by qualified Company Secretaries and corporate advocates with 15+ years of specialized experience in statutory compliance, certification, and corporate law.
Pre-Filing Quality Review
Structured document reviews help identify missing information, inconsistencies, and filing risks before submission to the relevant authority.
Fast-Track Turnaround
Streamlined internal workflows, digital portal filing acceleration, and dedicated case managers keeping you updated at every single milestone.
End-to-End Confidentiality
Bank-grade data confidentiality and legally binding NDAs protecting your business records, proprietary technical data, and corporate filings.
Transparent Fixed Pricing
Clear, all-inclusive professional fees without hidden charges or surprise surcharges. Complete clarity before filing begins.
Post-Approval Support
Ongoing compliance tracking, annual renewal reminders, statutory register updates, and dedicated helpline for all future legal requirements.
Frequently Asked Questions
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Medical devices are classified based on risk: Class A (Low Risk - e.g. surgical dressings), Class B (Low-Moderate Risk - e.g. needles, catheters), Class C (Moderate-High Risk - e.g. bone implants, ventilators), and Class D (High Risk - e.g. coronary stents, cardiac pacemakers).
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Class A and Class B manufacturing licenses (Form MD-5) are issued by the State Licensing Authority (State Drug Controller). Class C and Class D manufacturing licenses (Form MD-9) are issued centrally by the Central Licensing Authority (DCGI / CDSCO HQ, New Delhi).
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A Notified Body is an independent third-party audit organization (such as TÜV SÜD, TÜV Rheinland, Intertek) registered with CDSCO to audit Quality Management Systems (ISO 13485) and inspect Class A and Class B manufacturing sites on behalf of the government.
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Foreign manufacturers without a physical presence in India must appoint an Authorized Indian Agent (AIA) who holds a valid wholesale drug license (Form 20B/21B) to submit Form MD-14 and assume statutory regulatory responsibility for product quality in India.
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Medical Device Manufacturing Licenses (MD-5, MD-9) and Import Licenses (MD-15) are valid perpetually (for lifetime), subject to payment of statutory license retention fees every 5 years.
Ready to Get Started with CDSCO License (Medical Devices Manufacturing & Import MD-5 / MD-9 / MD-14)?
Schedule a confidential consultation with our Senior Company Secretaries and Legal Advisors. We provide strategic guidance, document preparation, and fast-track execution.
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