CDSCO Medical Device Submission – End-to-End Process & Required Documents
India’s CDSCO (Central Drugs Standard Control Organization) regulates medical devices under the
Medical Devices Rules (MDR), 2017. The submission process depends on whether the device is
manufactured in India or imported.
1. End-to-End Submission Process for CDSCO Approval
Step 1: Determine If the Device is Regulated by CDSCO
CDSCO only regulates “notified” medical devices.
Check the latest CDSCO notification list to confirm if your device needs registration.
If not notified → No approval needed yet.
If notified → Proceed with the submission process.
Step 2: Determine Device Classification
Medical devices in India are classified based on risk:
Class A – Low risk (e.g., thermometer, surgical gloves)
Class B – Low-moderate risk (e.g., syringes, nebulizers)
Class C – Moderate-high risk (e.g., ventilators, orthopedic implants)
Class D – High risk (e.g., pacemakers, heart valves)
📌 Regulatory Authority Based on Class:
Class A & B → State Licensing Authority (SLA)
Class C & D → Central Licensing Authority (CLA - CDSCO)
Step 3: Choose the Correct Registration Pathway
For Imported Devices → Apply for an Import License (Form MD-15).
For Domestic Manufacturing → Apply for a Manufacturing License:
o Class A & B → Form MD-5
o Class C & D → Form MD-9
Step 4: Prepare the Required Documents
A complete submission includes technical, quality, and safety documentation.
📌 Key Documents for CDSCO Submission:
A. General Documents
1. Application Form – MD-5, MD-9, or MD-15 (depending on classification & origin).
2. Cover Letter – Summary of the device, classification, and purpose of submission.
3. Power of Attorney (PoA) – If an Authorized Indian Representative (AIR) is used (for imported
devices).
B. Technical Documents (Device Master File - DMF)
4. Device Description – Overview of the medical device, including classification.
5. Intended Use & Indications – The purpose of the device and its clinical application.
6. GSPR (General Safety and Performance Requirements) Compliance – Proof of compliance
with Indian MDR 2017.
7. Risk Classification Justification – Explanation of how the device is classified (Class A, B, C, or
D).
8. BOM (Bill of Materials) & DMR (Device Master Record) – List of device components.
9. Design and Manufacturing Information – Details on design control, drawings, and
specifications.
10. Labeling & IFU (Instructions for Use) – Must meet CDSCO & BIS labeling requirements.
11. UDI (Unique Device Identification) – If applicable.
C. Quality & Testing Documents
12. Sterilization & Biocompatibility Reports – For devices that contact the body.
13. BIS Certification – If required under Indian standards (IS/ISO/IEC 60601, IS 15579, etc.).
14. Performance & Bench Testing Reports – Verification of device functionality.
15. Clinical Evaluation Report (CER) – Required for Class C & D devices.
D. Post-Market & Risk Management Documents
16. Risk Management File (ISO 14971 Compliance) – Risk assessment & mitigation.
17. Post-Market Surveillance (PMS) Plan – Strategy for monitoring device safety after market
approval.
18. Adverse Event Reporting (Materio-Vigilance Plan) – Plan for monitoring and reporting
device-related issues.
E. Manufacturing & Supplier Documents
19. Plant Master File (PMF) – Details on the manufacturing facility.
20. Process Validation Reports (IQ/OQ/PQ) – Ensures manufacturing consistency.
21. Supplier Qualification & Quality Agreements – If suppliers are involved in manufacturing.
Step 5: Submission & CDSCO Review
Submit the application via SUGAM Portal (CDSCO’s online submission system).
CDSCO Review Process:
o Class A & B Devices – Reviewed within 2-3 months (State Licensing Authority).
o Class C & D Devices – Reviewed within 6-12 months (CDSCO HQ).
Facility Inspection (if required) – CDSCO may inspect manufacturing sites for compliance.
Step 6: Approval & Market Entry
If the submission is approved, CDSCO issues:
o Manufacturing License (MD-5 / MD-9) for domestic manufacturers.
o Import License (MD-15) for foreign manufacturers.
Once the license is obtained, the medical device can be legally marketed in India.
Step 7: Post-Market Compliance & Renewals
📌 After approval, manufacturers must ensure ongoing compliance:
✅ Adverse Event Reporting – Mandatory under Materio-Vigilance Program of India (MVPI).
✅ Post-Market Surveillance Reports – Required for all classes.
✅ Periodic Safety Updates – Mandatory for high-risk devices (Class C & D).
✅ License Renewal – Required every 5 years.
How to Explain in an Interview?
"CDSCO regulates medical devices under MDR 2017. The approval process depends on the device
classification (Class A, B, C, or D). First, we confirm if the device is notified and determine the correct
registration pathway (Manufacturing or Import License). The submission requires technical
documentation, quality reports, clinical data (for high-risk devices), and post-market surveillance
plans. After submission through the SUGAM Portal, CDSCO reviews the application, conducts
inspections (if necessary), and grants approval. Post-market compliance, including PMS and adverse
event reporting, is mandatory to maintain the license."
Would you like a one-page summary for quick revision before your interview? 🚀
