Cdsco registration for medical devices (Mumbai)

Cdsco registration for medical devices

How to Register Medical Devices with CDSCO in India? CDSCO registration mandates import, manufacture, and sale of medical devices under Medical Devices Rules 2017, classifying them into A (low risk, e.g., bandages), B (low-moderate, e.g., hypodermic needles), C (moderate-high, e.g., ventilators), D (high, e.g., pacemakers). Foreign manufacturers appoint Indian Authorized Agents (IAA) for SUGAM portal filings.​ Step-by-Step Registration Process Classify Device: Use CDSCO list or risk-based matrix; non-notified devices register via MD-42. Appoint IAA: Local agent handles submissions (Form MD-14 for A/B, MD-15 for C/D). Prepare Dossier: Compile Device Master File (DMF), Plant Master File (PMF), ISO 13485/QMS cert, Free Sale Certificate, clinical data, STED/STED-like format. Online Submission: Upload via cdscoonline.gov.in; pay fees (₹3, 000-₹50, 000/class). Review & Inspection: CDSCO examines (3-12 months); site audits for C/D; address queries.​ License Issuance and Validity Form MD-3 (import registration), MD-5 (manufacturing) issued for 3-5 years; annual fee ₹1, 000. Post-approval: Local testing (if required), labeling in English/Hindi, post-market surveillance.​ Timelines by Class Class Review Time Inspection A/B 3-6 months Rare C/D 6-12 months Common Noida importers/manufacturers gain expedited approvals via AccountsWaale dossier prep, IAA coordination, compliance ensuring market entry in 4-9 months.