Obtaining a manufacturing or import licence is not the end of a medical device's regulatory lifecycle. Once a medical device or in-vitro diagnostic medical device (IVD) is placed on the Indian market, manufacturers and import licence holders must continue to monitor safety, quality and performance and take appropriate action when safety or performance concerns are identified.
This ongoing activity is commonly referred to as Post-Market Surveillance (PMS).
In India, medical devices and IVDs are regulated under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017 (MDR 2017), administered through the applicable Central or State Licensing Authority. CDSCO also operates medical-device vigilance and post-market surveillance mechanisms, including the Materiovigilance Programme of India (MvPI) and the online Medical Device Portal.
PMS is therefore an important part of the medical-device regulatory lifecycle. It helps identify previously unrecognised risks, monitor known risks, evaluate adverse events and complaints, and support appropriate corrective or preventive action.
What Is Post-Market Surveillance (PMS)?
Post-Market Surveillance is the systematic collection, recording, assessment and analysis of information relating to a medical device after it has been placed on the market.
PMS information may come from:
The objective is to determine whether the medical device continues to meet applicable requirements for safety, performance and quality and whether additional risk-control measures are necessary.
PMS should be considered a continuous lifecycle activity, rather than a one-time exercise.
Why Is PMS Important for Medical Devices?
Medical devices can encounter risks that are not fully apparent during development, testing or pre-market evaluation.
Real-world use can reveal:
A properly implemented PMS system helps a manufacturer or licence holder:
Regulatory Framework for PMS in India
The principal regulatory framework includes:
1. Drugs and Cosmetics Act, 1940
Medical devices falling within the applicable statutory definition are regulated under the Drugs and Cosmetics Act, 1940.
2. Medical Devices Rules, 2017
The Medical Devices Rules, 2017 establish the regulatory framework for manufacture, import, sale and distribution of medical devices and include requirements relevant to safety, quality, adverse-event reporting, recalls and post-market obligations. CDSCO maintains the current MDR 2017 materials and amendments on its official website.
3. Materiovigilance Programme of India (MvPI)
MvPI is the national programme for monitoring, recording and analysing adverse events and risks associated with medical devices and IVDs. The Indian Pharmacopoeia Commission (IPC) serves as the National Coordination Centre for MvPI.
CDSCO has specifically requested medical-device licence holders to use the MvPI platform for reporting adverse events and serious adverse events associated with their devices.
4. CDSCO Medical Device Portal
CDSCO has also operationalised online processes for medical-device regulatory activities, including a Periodic Safety Update Report (PSUR) module for medical devices. The current CDSCO PSUR module states that importers/manufacturers can submit PSUR applications through the Medical Device Portal.
Who Is Responsible for PMS?
PMS responsibilities depend on the regulatory role of the organisation and the applicable licence and regulatory requirements.
Manufacturers and Medical Device Licence Holders
Manufacturers should establish appropriate systems and procedures for:
The CDSCO circular dated 15 May 2024 specifically emphasised that medical-device licence holders should establish robust systems and processes for the timely identification, documentation and reporting of adverse events associated with medical devices.
Import Licence Holders and Authorised Representatives
For imported devices, the Indian regulatory entity should maintain appropriate systems for receiving and escalating complaints and safety information to the relevant manufacturer and for fulfilling applicable regulatory obligations.
The exact obligations depend on the entity's role under MDR 2017 and the conditions of the applicable import licence. Therefore, importers and authorised representatives should not assume that every PMS activity has the same statutory reporting requirement or timeline.
Materiovigilance Programme of India (MvPI)
The Materiovigilance Programme of India (MvPI) plays an important role in India's medical-device safety surveillance system.
The CDSCO/IPC Medical Device Adverse Event Reporting Form is designed to collect information about medical-device adverse events in India and can be used by manufacturers, importers, distributors, healthcare professionals and other relevant reporters.
The form captures information such as:
Important CDSCO Update
In May 2024, CDSCO issued a specific circular to medical-device licence holders concerning adverse-event reporting under MvPI. The circular emphasised timely identification, documentation and reporting of adverse events and requested licence holders to use the MvPI platform for reporting adverse events and serious adverse events.
Accordingly, medical-device licence holders should have a documented procedure for receiving, evaluating, escalating and reporting relevant adverse-event information.
Key Components of an Effective PMS System
1. Complaint Handling
A robust PMS system should include a documented complaint-handling process.
Complaints may relate to:
Each complaint should be assessed to determine:
2. Adverse-Event Monitoring and Reporting
Medical-device licence holders should maintain procedures for identifying, evaluating, documenting and reporting adverse events.
Potential events may include:
The CDSCO MvPI reporting framework provides a standardised mechanism for reporting medical-device adverse events.
Regulatory Reporting Under MDR 2017
Manufacturers and other regulated entities should assess each event against the specific reporting obligations applicable to their licence and regulatory role.
For example, Rule 26 of the Medical Devices Rules, 2017 contains specific obligations for manufacturing licence holders concerning suspected unexpected serious adverse events and related actions. The applicable licensing authority must be informed in accordance with the Rule, including the specified reporting timeline.
Therefore, PMS procedures should include a documented regulatory-assessment step rather than treating every complaint as an automatically reportable event.
3. Trend Analysis
A single complaint may not always indicate a systemic safety problem.
However, multiple similar complaints or a change in the frequency/severity of complaints may indicate an emerging risk.
Trend analysis may consider:
Trend information should be periodically reviewed to determine whether additional investigation, CAPA, risk-control measures or regulatory action is necessary.
4. Risk Management and PMS Feedback
PMS information should feed back into the device's risk-management process.
For example, newly identified post-market information may require review of:
PMS should therefore not operate as a standalone complaint database. It should be connected with the manufacturer's overall quality and risk-management system.
5. Corrective and Preventive Action (CAPA)
Where a complaint, adverse event, trend or investigation identifies an actual or potential systemic problem, appropriate corrective and preventive action should be considered.
Examples may include:
CAPA should be documented, implemented and followed up to determine whether the action was effective.
6. Field Safety Corrective Action (FSCA)
A Field Safety Corrective Action (FSCA) may be necessary when a device already placed on the market requires corrective action to reduce an identified risk.
Depending on the circumstances, corrective action may include:
The action should be based on an appropriate assessment of the identified risk and should be managed through a documented procedure.
For devices presenting a safety concern, the applicable recall and regulatory requirements under the Medical Devices Rules, 2017 must also be considered.
7. Recall Management
A recall is one possible regulatory and risk-control response when a marketed medical device presents an unacceptable or significant risk.
A recall procedure should define:
Recall procedures should be tested periodically so that the organisation can respond quickly when a real safety issue occurs.
8. Periodic Safety Update Reports (PSUR)
Periodic Safety Update Reports (PSURs) are an important part of the evolving post-market regulatory framework for medical devices and IVDs in India.
CDSCO has established a PSUR module within the Medical Device Portal. The current CDSCO user manual states that importer/manufacturers can apply for PSUR and submit the required documentation through the portal.
CDSCO's circulars page also specifically lists the March 2024 circular concerning submission of PSURs for medical devices/IVDs through the Medical Device Portal.
A PSUR process can support periodic evaluation of:
Important Compliance Point
PSUR obligations should be assessed according to the applicable CDSCO requirements, device/licence status and current portal instructions. Companies should not automatically apply drug PSUR timelines to medical devices, because medical-device requirements operate through the medical-device regulatory framework and applicable CDSCO instructions.
9. PMS Documentation and Records
A medical-device organisation should maintain appropriate and traceable PMS records.
Depending on the device and regulatory obligations, records may include:
Records should be controlled, retrievable and maintained in accordance with applicable regulatory and QMS requirements.
10. PMS and Quality Management System
PMS should be integrated with the organisation's quality-management system.
The PMS process should have defined interfaces with:
The objective is to ensure that post-market information is not simply collected but is actually evaluated and used to maintain the safety and performance of the device.
PMS Workflow for Medical Devices in India
A practical PMS workflow can be structured as follows:
Marketed Device
↓
Collect Post-Market Information
Complaints | Adverse Events | Service Data | User Feedback | Returns | Literature/Regulatory Information
↓
Initial Evaluation
Is there a safety, quality or performance concern?
↓
Adverse-Event Assessment
Is regulatory/MvPI reporting required?
↓
Investigation
Root Cause | Risk Assessment | Trend Evaluation
↓
Regulatory Action
MvPI Reporting | Regulatory Notification | PSUR, where applicable
↓
Corrective Action
CAPA | Labelling Update | Software Correction | Design/Process Change
↓
Field Action
FSCA / Recall, where necessary
↓
Effectiveness Check
Confirm that the action has reduced or eliminated the identified risk.
↓
PMS Review
Feed the information back into risk management and the QMS.
Best Practices for CDSCO PMS Compliance
Medical-device organisations should consider the following practices:
Common PMS Compliance Mistakes to Avoid
Organisations should avoid:
PMS Compliance Checklist for Medical Device Licence Holders
Before considering a PMS system effective, organisations should verify that they have:
Conclusion
Post-Market Surveillance is an important component of medical-device lifecycle management in India.
Under the Medical Devices Rules, 2017 and associated CDSCO mechanisms, medical-device licence holders need appropriate systems for monitoring safety and performance, handling complaints, evaluating adverse events and taking appropriate corrective action.
The Materiovigilance Programme of India (MvPI) provides an important national mechanism for medical-device adverse-event reporting. CDSCO's May 2024 circular further emphasised timely identification, documentation and reporting of medical-device adverse events by licence holders.
In addition, CDSCO has operationalised a PSUR module for medical devices and IVDs through the Medical Device Portal, making periodic safety information an important consideration in the modern Indian PMS framework.
An effective PMS system should therefore connect complaint handling, adverse-event reporting, trend analysis, risk management, CAPA, PSUR where applicable, FSCA and recall activities into one controlled lifecycle process.
For manufacturers and import licence holders, PMS should not be treated simply as a regulatory formality. A well-designed PMS system helps identify emerging risks, supports regulatory compliance and, most importantly, contributes to the continued safety and performance of medical devices available to patients and healthcare professionals in India.
Last Updated : 24 Aug 2026
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