A New Compliance Push from India’s Materiovigilance Regulator
Medical device companies operating in India received a pointed reminder in early 2026: post-market surveillance is not a paperwork formality — it is a standing legal obligation that regulators are now actively enforcing. The Indian Pharmacopoeia Commission (IPC), acting as the National Coordination Centre (NCC) for the Materiovigilance Programme of India (MvPI), issued a formal circular titled “Strengthening Adverse Event Reporting under the Materiovigilance Programme of India (MvPI) – Compliance by Medical Device Marketing Authorisation Holders,” with an enforcement date of 22 January 2026. The directive was subsequently echoed at the state level, with the Government of Puducherry’s Department of Drugs Control directing all Marketing Authorization Holders to ensure strict compliance by promptly reporting all Medical Device Adverse Events (MDAEs) to the NCC-MvPI, IPC.
This is a meaningful signal for any company holding a CDSCO manufacturing or import licence for a notified medical device or IVD: materiovigilance reporting is moving from a voluntary best practice to an actively monitored compliance line item, with state drug control departments now amplifying central directives.
What the January 2026 Circular Actually Requires
The IPC circular is unambiguous about scope and channel. All Marketing Authorisation Holders are required to ensure strict compliance by promptly reporting all medical device adverse events, including serious and non-serious, known and unexpected events, to NCC-MvPI, IPC through the appropriate MvPI reporting modality, preferably via ADRMS. This removes any ambiguity that only “serious” or “unexpected” events warrant reporting — the regulator now expects a comprehensive net of adverse event capture, not selective disclosure.
The circular also reinforces the underlying rationale: the safety and quality of medical devices, including in-vitro diagnostics (IVDs), depend on robust monitoring of device-related adverse events, and inadequate detection or delayed reporting can result in late identification of risks, potentially affecting patient outcomes and public health. A strong post-market surveillance system is therefore essential for early risk detection and timely regulatory intervention.
ADRMS: The Preferred Digital Reporting Channel
A central plank of this compliance push is the Adverse Drug Reactions Monitoring System (ADRMS). ADRMS, launched on 19 August 2024, serves as a unified national digital platform for reporting adverse events related to medicines, medical devices, and vaccines. Where earlier reporting relied on fragmented, manual channels, traditional approaches to adverse event reporting for medical products typically involved physical documentation, telephonic communication, and email-based submissions, which were fragmented, time-consuming, and heavily dependent on manual data entry, making them prone to reporting inconsistencies and human error.
ADRMS is designed to close these gaps. It enables healthcare professionals, manufacturers, and consumers to capture, validate, and track adverse event data in real time, ensuring faster responses and more informed decision-making. The platform integrates features such as semi-automated data validation and early quantitative analysis for signal detection, with interoperability with national and international regulatory databases. For MAHs, this means adverse event reports filed through ADRMS are now traceable, time-stamped, and subject to faster regulatory scrutiny than the old email/letter-based system allowed.
Why This Matters: The Institutional Backbone of MvPI
Understanding who sits behind this enforcement helps explain why compliance expectations are rising. MvPI was approved for commencement by the Ministry of Health and Family Welfare on July 6, 2015, to monitor the safety of medical devices in the country, and the Indian Pharmacopoeia Commission has functioned as its National Coordination Centre since 2018. Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Thiruvananthapuram acts as the National Collaboration Centre, the National Health System Resource Centre (NHSRC) provides technical support, and CDSCO supports MvPI with its experience as the national regulator.
On the ground, this multi-agency structure translates into an expanding reporting network. Under MvPI, a total of 174 Medical Device Adverse Event Monitoring Centres (MDMCs) have been identified across the country to report adverse events associated with medical devices, on a voluntary basis. Regional Training Centres — including institutions such as NIPER Hajipur — have been actively running sensitization and training programmes through 2026 to build reporting capacity among hospital OT, CSSD, and clinical staff, indicating that regulators are simultaneously building capacity on the healthcare-provider side while tightening obligations on industry.
The Broader PMS Landscape: PSURs and Digital Filing
The MvPI push does not exist in isolation. It sits alongside CDSCO’s continuing digitisation of post-market obligations. Periodic Safety Update Reports (PSURs) — the recurring safety summaries manufacturers must compile for higher-risk devices — must now be filed exclusively through the SUGAM portal, with physical submissions discontinued. Industry observers tracking CDSCO enforcement patterns note growing scrutiny of PSUR submission compliance, particularly for higher-risk Class C and D devices, alongside closer alignment of Indian post-market surveillance expectations with international frameworks such as EU MDR and ISO 13485.
Separately, CDSCO’s medical device portal has continued rolling out procedural updates in 2026 — including new provisions for IVD risk classification applications effective 18 February 2026 and medical device risk classification applications effective 27 November 2025 — reflecting a regulator that is steadily formalising every stage of the device lifecycle, from classification through to post-market vigilance.
Practical Takeaways for Marketing Authorisation Holders
- Register and activate an ADRMS account now. Do not wait for an adverse event to occur before setting up your organisational login — preferred reporting is via ADRMS, and delays in accessing the platform will directly translate into reporting delays.
- Report everything, not just “serious” events. The January 2026 circular explicitly covers serious and non-serious, known and unexpected events — recalibrate internal SOPs and complaint-handling triggers accordingly.
- Designate an internal materiovigilance owner. Someone within QA/RA must be responsible for triaging customer complaints, distinguishing reportable device-related adverse events, and filing within the expected timeframe.
- Maintain PSUR readiness for Class C/D devices. Ensure SUGAM portal access and documentation practices are current, as enforcement scrutiny on PSUR compliance is increasing.
- Train field and clinical-facing staff. IPC’s Regional Training Centres offer sensitization programmes — participating helps build the reporting culture regulators expect, and reduces the risk of missed or delayed adverse event capture at the point of care.
- Watch for state-level directives. Puducherry’s Drugs Control department has already issued its own compliance reminder; other state authorities may follow with parallel enforcement communications.
The Compliance Direction Is Clear
Materiovigilance in India is moving decisively from a voluntary, awareness-building exercise toward a monitored, digitally-tracked compliance obligation. For MAHs, importers, and authorised agents, the message from the January 2026 IPC circular is straightforward: build a documented, ADRMS-integrated adverse event reporting workflow now, rather than scrambling to demonstrate compliance during an inspection or licence renewal.
ACPL’s regulatory experts can help you navigate post-market surveillance and materiovigilance compliance. Contact us at info@acplgroupindia.co.in or call +91-9266665201 for a consultation.