[Home](/)/[Resources](/resources)/CDSCO Post-Market Surveillance IndiaVigilance Guide # CDSCO Post-Market Surveillance for Medical Devices Getting your CDSCO import license is only the beginning. Post-market surveillance is an ongoing legal obligation that continues for the entire time your device is sold in India. Failure to report adverse events or maintain vigilance can result in license suspension, recalls, and legal penalties. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fcdsco-post-market-surveillance) At a glance PMS obligations 4 PSUR contents 10 AE reporting 15 days ## Post-market surveillance obligations ### Adverse Event Reporting TimelineWithin 15 days of becoming aware TriggerDeath, serious injury, device malfunction that could cause death/serious injury Report ToCDSCO through Materiovigilance Programme of India (MvPI) ### Field Safety Corrective Action (FSCA) TimelineWithin 24-48 hours for serious risk TriggerDevice recall, modification, exchange, or destruction for safety reasons Report ToCDSCO and all affected healthcare facilities ### Periodic Safety Update Report (PSUR) TimelineEvery 6 months for Class C/D; annually for Class B TriggerScheduled reporting regardless of incidents Report ToCDSCO with summary of adverse events and risk-benefit analysis ### Incident Investigation TimelineWithin reasonable time based on severity TriggerAny complaint suggesting device did not perform as intended Report ToMaintain records; report if meets adverse event criteria ## Adverse event reporting hierarchy 01 Healthcare professional or user reports incident to manufacturer/Authorized Agent 02 Authorized Agent evaluates report against adverse event criteria 03 If reportable: submit to CDSCO/MvPI within 15 days via online portal or Form MD-26 04 For FSCA: implement field action and notify CDSCO immediately 05 Submit follow-up reports as investigation progresses 06 Include corrective actions and preventive measures in PSUR ## PSUR contents checklist 01Executive summary of device safety profile 02Cumulative sales data and patient exposure estimates 03Summary of all reported adverse events by type and severity 04Analysis of incident trends and signals 05Risk-benefit evaluation updates 06Summary of any field safety actions taken 07Update on risk management file changes 08Regulatory actions in other countries (if applicable) 09Proposed label changes or IFU updates 10Conclusion and recommendations ## Record retention requirements Record TypeRetention Period Adverse event reportsLifetime of device + 2 years Complaint filesMinimum 5 years PSUR submissionsIndefinitely Distribution recordsMinimum 5 years Field safety action recordsIndefinitely Risk management file updatesLifetime of device ## Frequently asked questions ### What qualifies as a reportable adverse event? Reportable adverse events under CDSCO include: (1) Death of a patient, user, or other person; (2) Serious injury to a patient, user, or other person; (3) Malfunction that would be likely to cause or contribute to death or serious injury if it were to recur; (4) Unanticipated serious device-related adverse events. Minor complaints, expected side effects documented in IFU, and user errors unrelated to device design are generally not reportable unless they reveal new risks. ### Do I need to report adverse events that occur outside India? Yes, CDSCO requires reporting of serious adverse events that occur anywhere in the world for the same device model marketed in India. Global safety signals must be included in your PSUR. If foreign regulatory actions occur (recalls, safety alerts, label changes), you must report these to CDSCO and assess whether similar action is needed in India. ### What is the Materiovigilance Programme of India (MvPI)? MvPI is India's national medical device adverse event reporting system, coordinated by the Indian Pharmacopoeia Commission. It collects, analyzes, and responds to medical device adverse events. Manufacturers and Authorized Agents report directly to MvPI for centralized data collection. Healthcare facilities can also report through MvPI. The system enables signal detection and national-level safety interventions. ### What happens if I fail to report an adverse event on time? Delayed adverse event reporting is a serious violation under the Medical Device Rules. Consequences include: show-cause notice from CDSCO, license suspension or cancellation for repeat violations, increased scrutiny of future applications, potential penalties under Drugs and Cosmetics Act, and reputational damage affecting relationships with healthcare providers. Establish robust vigilance procedures to ensure timely reporting. ### Can I use my global post-market surveillance system for India requirements? Yes, if your global system captures and reports events per Indian requirements. However, you need India-specific elements: Authorized Agent receiving complaints, reporting to MvPI in required format, PSUR submissions on India schedule (which may differ from other countries), and tracking of India-specific field actions. Many multinational manufacturers integrate India into global systems with local customization. **Disclaimer:** This guide reflects current CDSCO post-market surveillance requirements under Medical Device Rules 2017. Vigilance procedures and reporting formats may be updated. Always verify current requirements with official CDSCO and MvPI notifications. 🇮🇳 India roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇮🇳 India compliance for you? 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