Ensuring the continued safety, quality, and performance of medical devices after they are placed on the Indian market is a core requirement of the Medical Devices Rules, 2017 (MDR 2017).
Post-market surveillance (PMS) is not optional CDSCO expects every manufacturer and importer to build a structured PMS system that actively collects, investigates, and reports safety information throughout the device lifecycle.
Below is a clear, practical explanation of PMS requirements under India MDR, based fully on the rule framework and recognised guidance used by regulatory professionals across Indi
1. PMS Obligations as per India MDR
MDR 2017 requires that every manufacturer and importer must implement a PMS system that covers:
- Collection of complaints and adverse events
- Investigation and root-cause analysis
- Corrective and preventive actions (CAPA)
- Trend analysis
- Submission of mandatory reports to CDSCO
These obligations stem mainly from:
- Chapter VII – Post-approval changes, recalls & vigilance
- Chapter XI – Duties & functions of license holders
- Part of Quality Management System (QMS) requirements aligned to ISO 13485
2. Mandatory Adverse Event Reporting (Materiovigilance)
Under MDR, reporting Medical Device Adverse Events (MDAE) is compulsory.
Manufacturers & importers MUST report:
- Serious Adverse Events (SAEs)
- Events causing death or serious deterioration of health
- Device malfunction leading to serious risk
- Events occurring in India or internationally if the device is marketed in India
Timeline (as expected under global and Indian vigilance norms)
- Serious events: Immediately / within 15 days
- Deaths: As early as possible
- Periodic safety summaries: As required by CDSCO
Reporting is done through:
- Materiovigilance Programme of India (MvPI)
- CDSCO’s Adverse Event Form for Medical Devices
MvPI functions as India’s official vigilance system, coordinated by:
- Indian Pharmacopoeia Commission (IPC)
- CDSCO
- National Coordination Centre (NCC-MvPI)
3. Complaint Handling Requirements
Every company must maintain:
- A Complaint Register
- Documentation of every complaint received
- Investigation records
- Verification and validation of corrective actions
- Documentation of decision logic (e.g., “Is this reportable to CDSCO?”)
This is directly required under MDR’s licensing conditions and aligns with ISO 13485 Clause 8.
4. Corrective & Preventive Action (CAPA)
If PMS shows a defect or safety risk, the manufacturer/importer must:
- Investigate the root cause
- Implement Corrective Actions
- Implement Preventive Actions to avoid recurrence
- Document all actions in the QMS
- Report significant corrective actions to CDSCO
CAPA is also triggered when complaint trends indicate an emerging risk even if individual cases were not serious.
5. Field Safety Corrective Actions (FSCA) & Field Safety Notices (FSN)
If a risk is confirmed, companies must take actions such as:
FSCA Examples
- Device recall (voluntary or CDSCO-directed)
- Software update
- Labeling/IFU changes
- Modification of device components
Field Safety Notice (FSN)
A formal communication to users explaining:
- The risk
- What actions users must take
- Replacement, return, or modification procedures
Under MDR, all FSCAs and FSNs must be immediately reported to CDSCO.
6. PMS Data Collection & Trend Analysis
Companies must continuously collect:
- Complaint data
- Adverse event reports
- Returned device analysis
- Servicing reports
- Internal manufacturing nonconformities
- International vigilance data (if applicable)
Trend analysis is required to identify:
- Increased frequency of a failure mode
- Repeated malfunction patterns
- Usage-related issues not seen during pre-market testing
Any trend indicating increasing risk may require a vigilance report or FSCA.
7. Periodic PMS Reporting Requirements
While MDR does not mandate a fixed template like the EU PSUR, CDSCO expects:
- Periodic Safety Update Reports (PSURs)
- Summary of complaints and adverse events
- Actions taken
- Global safety information
These reports may be requested during:
- Audit/inspection
- Renewal of license
- Risk-related evaluation
8. Manufacturer & Importer Responsibilities (per MDR licensing conditions)
Under MDR, every license holder must:
- Maintain an effective QMS with vigilance procedures. Maintain traceability records.
- Report adverse events & recalls
- Allow CDSCO inspection at any time
- Maintain documentation for not less than 5 years
Non-compliance can lead to:
- Suspension of license
- Cancellation of import/manufacturing license
- Product recall
- Regulatory penalties
Conclusion:
Post-Market Surveillance under India MDR is essential to ensuring that medical devices remain safe and effective long after they enter the market. Manufacturers and importers must continuously monitor product performance, investigate complaints, report adverse events through MvPI, and implement corrective actions whenever risks are identified. Maintaining strong documentation, conducting trend analysis, and responding promptly to CDSCO requirements form the core of a compliant PMS system. When done well, PMS not only meets regulatory expectations but also protects patients and strengthens trust in the device’s long-term reliability.
References
- Medical Devices Rules, 2017 (MOHFW Notification G.S.R. 78(E))
- CDSCO Notice on Materiovigilance (Implementation of MvPI)
- CDSCO Adverse Event Reporting Form (Medical Device MDAE Form)
- IPC Materiovigilance Programme Guidance Documents
- ISO 13485:2016 (Referenced in MDR as required QMS)