Post Market Surveillance (PMS) in India: A Global Comparison with Europe and the U.S FDA
Post Market Surveillance in India vs EU & US FDA: A Comparative View
When a novel IVD has reached the commercialization level, the role of regulation becomes just the beginning point. It is necessary to assess the performance of the device in actual settings. This is where Post Market Surveillance (PMS) plays its role.
PMS serves as the main support of patient safety through detection of risks, implementation of necessary corrections, and maintaining safe and effective performance of the device at all stages of its lifecycle.
This blog post explains how PMS is conducted in India, Europe, and USA in terms of the particular regulatory system and the corresponding requirements for conducting PMS. A comparative table is presented.
Comparative Overview of PMS Frameworks: India, EU, and U.S
Regulatory Domain | India (CDSCO / MvPI) | Europe (EU MDR/IVDR) | United States (FDA) |
|---|---|---|---|
System | Operates through MvPI supported by regular PSUR reporting. | PMS framework integrated within MDR/IVDR. | Combination of MDR reporting and Section 522 post-market studies. |
PSUR / PMS Reporting | Applicable to every category of device. | PSUR applies to Class IIa–III categories, with PMSR applicable to Class I devices. | No PSUR mechanism; instead, MDR reporting and mandated studies apply. |
Reporting Frequency | Reports every 6 months for the first two years, followed by annual submissions for the next two years. | Class III and IIb devices require annual reporting, Class IIa devices every two years, and Class I devices only when necessary. | Reports are only submitted in response to incidents. |
Databases | Submissions made via Sugam Portal and IPC reporting forms. | Data uploaded into the EUDAMED database. | Information maintained in MAUDE and electronic MDR systems. |
Adverse Event Reporting | Compulsory for manufacturers and importers; user reporting remains optional. | Serious events must be reported within 2 15 days, depending on severity. | Timelines: 10 days for fatalities, 30 days for injuries, and 5 days for serious risks. |
Additional Obligations | Structured vigilance activities along with PSUR submission. | Need for a documented PMS approach supported by ongoing post-market clinical follow up (PMCF) | Section 522 requires additional post-market studies for higher-risk products. |
Philosophy | Emerging and progressively systematized. | Entirely lifecycle-oriented. | Predominantly reactive and targeted. |
Transparency | Public access is limited. | Broad access provided through a centralized EUDAMED system. | High transparency with data openly available via MAUDE. |
India: Post Market Surveillance (PMS) and Materiovigilance Programme of India (MvPI)
The Post Market Surveillance (PMS) is the comprehensive scheme to monitor medical devices post their approval to keep them safe and efficacious. In this scheme, the Materiovigilance Programme of India (MvPI) is the national scheme for adverse events associated with medical devices.
Simplified explanation:
PMS – This is the overall requirement for post-approval monitoring which includes all post-marketing activities such as PSURs, risk assessment, and even product recalls.
MvPI – This is a special surveillance system developed in India to deal exclusively with safety reports by manufacturers, hospitals, and even patients.
Thus, PMS and MvPI make up a comprehensive safety net for patients.
India Materiovigilance Programme (MvPI): Development of a structured system for receiving and evaluating the data of adverse events and device malfunctioning.
Established in 2015 to develop a structured system for monitoring the safety of devices.
Implemented by:
CDSCO – regulatory authority
Indian Pharmacopoeia Commission (IPC) – national monitoring and reporting system.
AIIMS, New Delhi – technical coordination.
Reportable Channels:
Compulsory: Manufacturers and Importers governed under the Medical Device Rules, 2017.
Optional: Hospitals, Doctors, and Patients.
How to report?
Unlike the European Union’s EUDAMED or FDA’s MAUDE/eMDR in America, there is currently no online reporting portal available in India for Medical Device Vigilance. MvPI follows a form-based reporting process, along with electronic and postal means of submitting information.
For Healthcare Practitioners, Hospitals, and Patients
➔ Reporting is voluntary but strongly recommended.
➔ Click here to download the MvPI reporting form from the IPC portal.
➔ Share information about the adverse incident, malfunction of the medical device or patient’s complaint.
➔ Submit the filled-in reporting form:
Via Email: mvpi-ipc@gov.in
By Post:
Indian Pharmacopoeia Commission
Ministry of Health & Family Welfare
Sector-23, Raj Nagar, Ghaziabad – 201 002
New Update (2025): Separate website for reporting MvPI has not been developed yet.
For Manufacturers & Importers
Adverse event reporting is made mandatory under MDR 2017 for manufacturers and importers.
This can be done by submitting it through the online portal of CDSCO Sugam. The following describes the procedure:
Sugam Portal Visit
Visit “CDSCO Online Portal” – Sugam Portal
Login/Register
A separate login will be required to be made by manufacturers and importers using organizational credentials.
For healthcare professionals or hospitals, reporting can be done from institutional accounts.
Materiovigilance Module
After login, click on the Medical Device Division.
Select “Adverse Event Reporting / Materiovigilance.”
Upload Data
Event data can either be entered in the system manually or by uploading completed MvPI adverse event reporting form.
Submit & Follow Up
Submit the report.
A unique ID will be provided in order to track the submission status.
Registered Medical Device Information Sharing Portal
Along with reporting forms, IPC has developed a Medical Device Information Sharing Portal to gather information on the registered devices, their manufacturers and suppliers. It helps in MvPI by enhancing the device database of MvPI.
Periodic Safety Update Reports (PSURs):
As per CDSCO circular (File No. PSUR-13011(15)/1/2024, dated 19 March 2024, pdf Link), filing of all PSURs in respect of medical devices and IVDs is now mandatory through the Online Portal for Medical Devices (Sugam portal).
Offline mode of filing PSURs by hard copy / email will not be entertained from 1 April 2024. It is advised that PSURs are to be filed via the online portal based on the prescribed checklist.
Aspect | Details |
|---|---|
Regulatory Basis | Mandatory under Medical Devices Rules (MDR), 2017 for all medical devices. |
Submission Frequency | • Every 6 months for the first 2 years after approval |
Report Must Include | • Safety data and complaints received |
Mode of Submission | Since April 2024, PSURs can only be submitted online via the CDSCO Sugam portal |
Reporting Timeframes (India)
Manufacturers/Importers: Severe Adverse Events within 15 Days.
Hospitals/Healthcare Providers: Severe adverse events within 15 Days, Non-severe adverse events within 30 Days.
Post Market Surveillance is everyone's joint responsibility. By collaborating with MvPI, PSUR, and Global Vigilance Programs, manufacturers can convert compliance into their competitive edge.
US FDA : Post-Market Surveillance (PMS)
There has been an elaborate Post-Market Surveillance (PMS) strategy by the Food and Drug Administration (FDA) to identify potential risks, enforce any required corrective actions, and ensure trustworthiness of health technologies. As opposed to the pre-market assessments that rely on controlled studies with small populations, PMS provides a continuous flow of real-world data from different settings.
PMS Framework of FDA
There are both statutory requirements and guidelines by which FDA regulates PMS. The two important provisions are:
Medical Device Reporting Rule of 21 CFR 803
Requires reporting of certain adverse events by manufactures, importers, and user facilities.
Involves cases of death, serious injuries or malfunction of the device.
Post-market Surveillance Studies of Section 522 of the FD&C Act
Gives FDA the power to request for surveillance studies for some class II/III devices.
Used when a device involves risk, is based on new technology, or needs further long-term data.
What Is Reported by Whom?
Manufacturers and Importers: Required to report deaths, serious injuries, and malfunctioning that may cause injury if repeated.
User Facilities (such as hospitals and nursing homes): Required to report deaths to FDA and manufacturers and serious injuries to the manufacturers (FDA if the manufacturer is unknown).
Distributors: Not responsible for submitting MDRs but are required to keep complaint files.
Mandated Timelines for MDR Submission
30 calendar days → Adverse event reporting in standard way.
5 working days → Urgent situations that need immediate action.
10 working days → Report from user facilities on death or serious injury.
Electronic Medical Device Reporting (eMDR):
From 2015, it has become mandatory to submit MDR report electronically through the ESG (FDA’s Electronic Submissions Gateway),
Using e-Submitter software (MedWatch Form FDA 3500A in XML format) or
AS2 Gateway (XML compliant with HL7 ICSR).
Transparency via MAUDE Database:
All MDRs filed are made accessible in the MAUDE database, providing for:
Access to safety data on devices,
Pattern recognition for safety, and
Increased accountability in the device industry.
Section 522 Post Market Surveillance Studies:
In case of high-risk devices, FDA could require a Section 522 study. Important features of Section 522 studies include:
1. Submission of a detailed study plan to be approved by the FDA.
2. Progress reports during the course of the study.
The study can be conducted through registries, post-approval clinical trials, or observation.
Recent Developments (2023 - 2025):
Improvements made in the eMDR validation process that would cut back on rejections.
Incentives for the use of real-world evidence (RWE) from EHRs, registries, and digital health data.
International Medical Device Regulators Forum harmonization efforts to align with the international standard.
FDA’s PMS system is based on a combination of reactive reporting and surveillance studies, making it evidence-based and adaptive. As far as medical device companies are concerned, PMS is not only about compliance with the regulation; it is also about increasing patient safety and innovation through the use of real-world data. An efficiently designed PMS plan will be quite beneficial for companies working in the United States.
Europe: Post Market Surveillance (PMS)
In terms of medical device safety, it is no secret that the European Union has one of the most forward-looking post-market surveillance regimes around the world. The key focus of EU Medical Devices Regulation (MDR 2017/745, pdf link) is on monitoring and evaluation of the device throughout its entire lifecycle.
Post-Market Surveillance (PMS) Plan
All manufacturers must include a PMS plan within their Technical documentation. This plan acts as the foundation for vigilance and must specify:
Data sources to be used (complaints, literature, registries, etc.)
Methods for data collection and analysis
Timelines for evaluations and reporting
Strategies for addressing identified risks
A well structured PMS plan ensures a systematic approach to monitoring device safety and performance.
Periodic Safety Update Reports (PSURs) under Article 86 of the MDR
PSURs represent one of the main pillars of PMS under the MDR:
Required for Class IIa-III medical devices, but Class I devices are subject to simplified PMS reports.
Content should include:
Summary of safety and performance information
Assessment of benefits and risks
CAPAs
Results of PMCF
Data on sales and distribution
Frequency:
Yearly for Class IIb and Class III medical devices
Biennial for Class IIa medical devices
All PSURs have to be posted to the EU’s centralized database, EUDAMED.
3. Alertness and Reporting of Serious Incidents
It is essential that manufactures report serious incidents or FSCAs to competent authorities. This depends on the severity of the event:
Within 2 days in case of a public health risk
10 days’ reporting period if the situation involves death or serious injury.
Within 15 days if the above does not apply.
This rigorous reporting system allows for quick regulatory intervention in case of any risks.
4. Post market Clinical Follow up (PMCF)
This is an anticipatory provision of MDR where more information is gathered from actual use in order to verify the safety and performance of medical devices.
Very important in high risk and new devices
Data from PMCF are considered in the PSUR and risk management file.
5. Guidance of MDCG about PSURs (MDCG 2022-21)
At the end of 2022, the Medical Device Coordination Group (MDCG) issued a guideline that is useful for manufacturers. The guideline includes the following:
Use of IMDRF code for reporting
A well structured format (device description, executive summary, data table, CAPA, benefit risk assessment)
Template presented in Annex I
Duty to report throughout the entire lifespan of the device (shelf life included)
6. Transparency via EUDAMED
The EUDAMED system is the centralized system of PMS in the EU:
Authorities from all member states can exchange information from the system
Greater transparency for the health care community and general population
Contributes to harmonization in the EU single market
7. Recent Trends (2023-2025)
Staged implementation of EUDAMED modules related to vigilance, PMS, and market surveillance
Increasing focus on data quality, traceability, and standardization
Consistency with IMDRF requirements for global standardization
Conclusion
Post-Market Surveillance (PMS) is one of the major aspects of the regulatory mechanism of medical devices which provides patient safety after market approval.
The PMS of India has become better owing to the Materiovigilance Programme of India (MvPI) and PSUR reporting, providing an organized structure of patient safety monitoring.
The European PMS is advanced as it involves the whole life cycle of a device using well structured tools like PSURs, PMS plans, and EUDAMED database.
The FDA PMS in America is very strong because of the event based process which includes mandatory adverse event reporting along with post-market study and use of public databases for availability of the data.
From this point of view, understanding such differences becomes an integral part of the process for any organization operating in several countries. Information about regional standards not only ensures compliance, but also establishes contacts with regulatory authorities, health care professionals and patients, emphasizing the importance of safety and accountability.
In Morulaa, we are not just here to assist you in getting into the Indian market but also to make sure that your devices are always compliant and safe with the full support of PMS and vigilance services.
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