[Home](/)/[Resources](/resources)/CDSCO Vigilance Reporting IndiaCDSCO / Vigilance # CDSCO Adverse Event Reporting, FSCA and Recall Timelines for Medical Devices Under the Medical Devices Rules 2017, a suspected unexpected serious adverse event, and any recall or corrective action taken on it, must be reported to the licensing authority within 15 days. Importers have the same 15 days to report a withdrawal or restriction imposed by any foreign regulator. Reports use the MvPI Medical Device Adverse Event (MDAE) form, and recalls must be started and notified immediately under Rule 89. This guide covers the vigilance side of post-market work in India: what to report, by when, to whom, and how recalls and FSCAs are handled. For the wider system (complaint handling, PMS plans and record retention), see the [CDSCO post-market surveillance guide](/guides/cdsco-post-market-surveillance). Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fcdsco-vigilance-reporting) At a glance Serious event deadline 15 days Legal basis MDR 2017, Rules 26, 38, 89 Reporting form MvPI MDAE form PSUR (no-predicate devices) 6-monthly, then annual ## Where the vigilance duties come from in MDR 2017 MDR 2017 has no single "vigilance chapter". The duties are spread across licence conditions, the recall rule and the Schedules. Which rows apply depends on whether you manufacture in India, import through an Authorised Agent, or hold a permission for a device with no predicate. Provision Applies to Obligation Timeline Rule 26(ii) Indian manufacturers (licence in Form MD-5, MD-6, MD-9 or MD-10) Inform the State or Central Licensing Authority of any suspected unexpected serious adverse event and the action taken on it, including any recall Within 15 days of the event coming to the licence holder's notice Rule 26(vi) Indian manufacturers If the licensing authority finds a lot non-conforming and directs it, withdraw the rest of the lot from sale and recall issued stock as far as practicable On direction of the licensing authority Rule 38(1)(ii) Import licence holders (Authorised Agent) Report any administrative action taken abroad on account of an adverse reaction: market withdrawal, regulatory restriction, cancellation of authorisation, or a not-of-standard-quality declaration in the country of origin or any other market Forthwith, and in all cases within 15 days Rule 38(1)(iii) Authorised Agent Stop despatch and marketing of the affected device in India Immediately Rule 38(2) Import licence holders CLA may direct that a batch, several batches or all batches be withheld from sale or recalled from the market, including hospitals As directed by the CLA Rule 89 Manufacturers and Authorised Agents If a device is likely to pose a risk to users or patients, initiate withdrawal from the market and patients, state the reasons, and inform the competent authority Immediately Rule 65(b) and (d) Holders of Form MD-27 permission (devices without a predicate) Submit PSURs from the date of launch; report suspected unexpected serious adverse events PSUR every 6 months for 2 years, then annually for 2 more years; SUSAEs within 15 days Fifth Schedule, 8.5.1 All manufacturers (QMS) Documented procedures for advisory notices and for notifying adverse events to the regulator; complaint investigation records Continuous (audited at inspection) ## Reportable event types and timelines Event type What it covers Timeline Suspected unexpected serious adverse event Rule 3(zq): an event that leads to death, a serious deterioration in health (life-threatening illness or injury, permanent impairment, in-patient or prolonged hospitalisation, or intervention to prevent these), or foetal distress, foetal death or a birth defect. MvPI also asks for near-misses that could have caused such harm Within 15 calendar days of awareness (Rule 26(ii); MvPI guidance) Foreign regulatory action on the same device Market withdrawal, restriction, cancellation of authorisation, or not-of-standard-quality declaration by the country of origin or any other regulator Forthwith, within 15 days (Rule 38(1)(ii)) Recall or Field Safety Corrective Action (FSCA) Any action to reduce risk from a device already supplied: return, design change, software upgrade, labelling or IFU change, destruction, or exchange Inform the authority immediately on deciding to act (Rule 89); include in the 15-day report where linked to a serious event Non-serious event (user facilities) Malfunctions or incidents that did not cause and could not have caused serious harm MvPI guidance asks user facilities to report within 30 calendar days Periodic Safety Update Report (PSUR) Interval safety data for a device approved without a predicate: new safety information, patient exposure, worldwide authorisation status, proposed labelling changes Every 6 months for 2 years, then annually for 2 years; due 30 days after each period ends (Seventh Schedule) ## MvPI and the MDAE reporting form The Materiovigilance Programme of India (MvPI) was launched on 6 July 2015 to track medical device adverse events. The Indian Pharmacopoeia Commission (IPC), Ghaziabad has been the National Coordination Centre (NCC-MvPI) since 2018. Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram is the National Collaborating Centre, NHSRC gives technical support, and CDSCO acts as the regulator. A network of Medical Device Adverse Event Monitoring Centres (MDMCs), mostly in hospitals, collects reports locally. Everyone reports on the same **Medical Device Adverse Event (MDAE) reporting form**, which is published on the CDSCO and IPC websites. Manufacturers, importers, distributors, healthcare professionals and patients can all use it. The form asks for the device's Indian risk class (A to D), model, lot or serial number, software version, the event, the patient outcome, and the manufacturer's assessment. Completed forms go to the nearest MDMC or straight to NCC-MvPI, and IPC also takes reports on its toll-free helpline, 1800-180-3024. MvPI reporting does not replace your duty under MDR 2017. A licence holder still has to inform the Central or State Licensing Authority within 15 days. In practice, file the MDAE form with both, using the submission channel in the latest CDSCO notice. **Where to check device safety actions:** CDSCO posts device recalls and alerts on the Product Recall and Latest Alerts pages of cdsco.gov.in, and IPC publishes MvPI safety alerts. India has no public, searchable adverse event database like the FDA's MAUDE. If you need history on a device type, such as dental implants, combine CDSCO/IPC alerts with recall databases from other regulators. ## Adverse event reporting process 01 ### Decide whether the event is reportable Ask three questions: did the device contribute to death or serious deterioration in health, could it have done so if the event recurred, and is a regulator anywhere taking action on this device? A yes to any of them starts the 15-day clock. MvPI guidance lists exclusions, such as defects always spotted by the user before use, or a failure caused only by exceeding the stated service life or shelf life. 02 ### Get the facts to your Indian licence holder fast For imported devices, the Authorised Agent holds the import licence and the reporting duty. The overseas manufacturer's complaint-handling system must forward Indian events, and relevant foreign actions, to the Authorised Agent within days, not weeks. The 15-day clock runs from awareness, not from the end of your internal investigation. 03 ### Complete the MDAE reporting form Use the Medical Device Adverse Event (MDAE) reporting form published by CDSCO and IPC under MvPI. It captures reporter details, patient outcome, device identification (risk class, model, lot or serial, software version), event description, and the manufacturer's assessment. An incomplete initial report sent on time is better than a complete one sent late. 04 ### Submit to the licensing authority and MvPI Send the report to the Central Licensing Authority (or the State Licensing Authority for State-licensed manufacture) and to the National Coordination Centre for MvPI at the Indian Pharmacopoeia Commission (IPC), Ghaziabad. Check the current CDSCO notice for the channel to use, as submission routes have changed over time. 05 ### Investigate the root cause Run the investigation under your Fifth Schedule QMS: device analysis, risk assessment, complaint trend review, and CAPA. Keep every record. Medical Device Officers and Notified Bodies can ask for them during an audit or inspection. 06 ### File follow-up and final reports Send follow-up reports with the causality assessment, root cause and CAPA. If the investigation leads to a recall or FSCA, file the FSCA notification (preliminary, follow-up or final) with the affected lots, consignee list and Field Safety Notice. ## Medical device recall timelines in India This is where most confusion starts. MDR 2017 says when to _start_ a recall and when to _report_ it, but not how fast it must be _completed_. The recall classes and 24-hour/72-hour deadlines often quoted online come from CDSCO's drug recall guidelines. Here is what each source actually says. Source Status What it says MDR 2017, Rule 89 Binding (devices) Initiate withdrawal and inform the competent authority immediately once the device is believed to be unsafe. No completion deadline is set. MDR 2017, Rules 26(ii) and 38(1)(ii) Binding (devices) Recall and other action taken on a serious event, or abroad, must reach the licensing authority within 15 days. CDSCO draft IVD materiovigilance guidance (CDSCO/IVD/GD/PMS/01/2022) Draft, IVDs only Notify the authority within 24 hours of deciding to recall, preliminary report within 24 hours of starting, final report within 21 days. CDSCO Guidelines on Recall and Rapid Alert System for Drugs Drugs only Class I: stop sale within 24 hours, complete physical recall within 72 hours. Class II: 10 days. Class III: 30 days. Often used as an internal benchmark for devices, but not legally applicable to them. ### Recall stages, in order (1) Decide to recall and set the depth: consumer or user, retail, or wholesale. (2) Inform CDSCO immediately with what you know (Rule 89). (3) Stop despatch. Importers must do this straight away when a foreign regulator acts (Rule 38(1)(iii)). (4) Send the Field Safety Notice to every consignee, with a way to confirm receipt and stock on hand. (5) Retrieve, correct or destroy units and reconcile quantities. (6) File the final FSCA report with proof of return and dealer completion declarations. A sensible internal target is to finish high-risk recalls within the drug Class I window. Plan for it, but cite MDR 2017 as your legal basis. ## Field Safety Corrective Action (FSCA) notification contents MvPI guidance includes an FSCA notification form with three report types (preliminary, follow-up/final, and notification). The manufacturer or its authorised representative can submit it. The preliminary and final notifications should cover: Reason for the FSCA and the FSCA strategy, if affected stock was supplied in India Health hazard evaluation and root cause analysis by the manufacturer or Authorised Agent CAPA planned to reduce the chance of the issue recurring Affected device identification: model, catalogue number, lot or serial numbers, software version List of Indian consignees and number of affected units per consignee; quantity manufactured, imported or supplied in India For devices made in India and exported: countries and quantities exported The Field Safety Notice (FSN) and any draft letter to healthcare professionals or print advertisement Final report: stock reconciliation, confirmation consignees received the FSN, proof of return for recalled units, and dealer declarations of completion ## PSURs: who submits them and when The fixed PSUR schedule in MDR 2017 applies to devices with **no predicate**, which are approved under Rule 63 with Form MD-27 permission after a clinical investigation. Rule 65(b) requires PSURs from the date of launch. Paragraph 3 of the Seventh Schedule sets the timing: every six months for the first two years, then annually for the next two years. Each PSUR covers only its interval and is due within 30 calendar days of the end of the period. The Central Licensing Authority can extend the total PSUR period. If launch is delayed, the clock starts when the device is actually marketed. Each PSUR covers one device and reports new safety information, patient exposure, worldwide authorisation status and safety-related variations, and any planned changes to product information. Suspected unexpected serious adverse events still go in separately within 15 days. They do not wait for the PSUR. Most devices licensed against a predicate do not have this fixed schedule. Their post-market evidence is the vigilance and PMS data in the device master file and the Fifth Schedule QMS records. The[CDSCO post-market surveillance guide](/guides/cdsco-post-market-surveillance) explains how to structure that PMS plan. ## Common mistakes ### Waiting for the root cause before reporting The 15-day deadline runs from awareness. File an initial report with what you know, then follow up. ### Reporting only Indian incidents Rule 38(1)(ii) also covers withdrawals, restrictions and quality declarations by foreign regulators. A global recall usually means an Indian report, even if no affected units were shipped here. ### Treating safety-related software updates as routine releases A software upgrade made to reduce risk is an FSCA under MvPI guidance. Record why each release is or is not safety-related. ### Applying the drug recall classes as if they were device law The 24-hour/72-hour Class I timeline comes from CDSCO's drug recall guidelines. It is a sensible internal target for devices, but quote MDR 2017 when you describe your legal obligation. ### No India owner for vigilance Name a person at the Authorised Agent who can receive complaints, file reports and coordinate field actions, with a backup for leave and holidays. ## Frequently asked questions ### What is the timeline for recall of medical devices in India? MDR 2017 does not set a recall completion deadline for devices. Rule 89 requires the manufacturer or Authorised Agent to start the withdrawal and inform the competent authority immediately once it believes a device may be unsafe, and Rules 26(ii) and 38(1)(ii) require the recall or foreign action to be reported within 15 days. CDSCO's drug recall guidelines (Class I: stop sale in 24 hours, finish in 72 hours; Class II: 10 days; Class III: 30 days) apply to drugs, not devices, but many companies use them as internal targets. CDSCO can also direct a recall of one, several or all batches under Rule 38(2). ### Within how many days must a serious adverse event be reported to CDSCO? Within 15 days. Rule 26(ii) of MDR 2017 requires manufacturing licence holders to report any suspected unexpected serious adverse event, and the action taken including any recall, within 15 days of it coming to their notice. Rule 38(1)(ii) sets the same 15-day limit for importers when a regulator abroad acts on the device. MvPI guidance uses 15 calendar days from awareness for manufacturers, importers and distributors. ### Where do I check or report adverse events for medical devices in India? Reports are made on the Medical Device Adverse Event (MDAE) reporting form under the Materiovigilance Programme of India (MvPI). IPC Ghaziabad runs the National Coordination Centre, and reports can also go through a Medical Device Adverse Event Monitoring Centre (MDMC) or the IPC helpline 1800-180-3024. Licence holders must also report to the licensing authority under MDR 2017. CDSCO publishes medical device recalls and alerts on the Product Recall and Latest Alerts pages of cdsco.gov.in. India does not have a public, searchable adverse event database like the US FDA's MAUDE. ### Must I report adverse events that happened outside India to CDSCO? Import licence holders must report, within 15 days, any administrative action taken abroad because of an adverse reaction: market withdrawal, regulatory restriction, cancellation of authorisation, or a not-of-standard-quality declaration (Rule 38(1)(ii)). The Authorised Agent must also stop despatch and marketing of that device in India straight away. For individual foreign incidents with no regulatory action, there is no express rule, but they belong in your PSUR (where one applies) and your trend analysis. Many importers report serious foreign events voluntarily. ### Who has to submit PSURs to CDSCO, and how often? Rule 65(b) applies the PSUR duty to holders of Form MD-27 permission, which covers devices with no predicate that were approved after a clinical investigation (Rule 63). The Seventh Schedule sets the schedule: every six months for the first two years after marketing approval, then annually for the next two years. Each report is due within 30 calendar days of the end of its reporting period, and the Central Licensing Authority can extend the total period. Devices licensed against a predicate do not have this fixed PSUR schedule, but still need complaint handling, vigilance and post-market data under the Fifth Schedule QMS. ### What is the difference between a recall and an FSCA? A Field Safety Corrective Action (FSCA) is any action taken to reduce risk from a device already on the market. MvPI guidance lists returning the device, design changes, software upgrades, labelling or IFU changes, destruction and exchange. A recall is one type of FSCA, where devices are removed from the market or from users (MDR 2017, Rule 3(zp)). All of these should be notified, not just recalls. ### Does a software update for a medical device need to be reported as an FSCA? If the update is made to fix a safety problem or reduce the risk of harm, yes. MvPI guidance names software upgrades as an FSCA. Routine updates that add features or fix bugs with no safety impact are generally not FSCAs. Write down the reasoning for each release, because CDSCO may ask why an update was not treated as an FSCA. ### What happens if CDSCO decides a device poses a serious risk? Under Rule 38(2), the Central Licensing Authority can direct that a batch, several batches or all batches be withheld from sale or recalled from the market, including from hospitals. For contraventions of the Act or the rules, Rule 30 lets the licensing authority suspend or cancel a manufacturing licence after a show-cause notice. Breaching the Drugs and Cosmetics Act, 1940 and its rules can also lead to prosecution. **Disclaimer:** This guide reflects the Medical Devices Rules 2017 (as published by CDSCO) and MvPI guidance as of October 2026. In February 2026, DTAB approved in principle amendments to Rules 26 and 38 that would define "reportable events" and formalise reporting to the licensing authority. These had not been notified at the time of writing. Check cdsco.gov.in and the e-Gazette for current rules, and get advice specific to your device. 🇮🇳 India roadmap for medical devices Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take medical devices through 🇮🇳 India compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. 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