All Marketing Authorisation Holders are hereby requested to ensure strict compliance by promptly reporting all medical device adverse events, including serious and non serious, known and unexpected events, to NCC-MvPU, IPC through appropriate MvPI reporting modality, preferably via ADRMS.
Patient safety and medical device quality, including in-vitro diagnostics (IVDs), rely heavily on vigilant monitoring of adverse events.A strong post-market surveillance system is vital for early risk spotting and swift regulatory responses, such as product recalls or modifications.
Launched by India’s Ministry of Health and Family Welfare on July 6, 2015, MvPI aims to track, document, and evaluate adverse events linked to medical devices and IVDs. IPC has served as the National Coordination Centre (NCC) since 2018, managing data collection nationwide, stakeholder training, signal detection, regulatory alerts, and evidence-sharing with the Central Drugs Standard Control Organisation (CDSCO) for interventions. It uncovers emerging risks, gauges known risk frequency and severity, and drives mitigations like design tweaks, label revisions, field safety actions, or other controls. For MAHs, it fortifies surveillance, aids product evolution, and builds confidence with regulators, clinicians, and patients.
MvPI offers user-friendly options: the Adverse Drug Reactions Monitoring System (ADRMS, launched August 19, 2024) as a unified digital hub for real-time reporting on drugs, devices, and vaccines; dedicated forms (e.g., MEDICAL_DEVICE_ADVERSE_EVENT_REPORTING_FORM Version 1.2); a mobile app (search “adr pvpi 2.0” on Google Play); and a toll-free helpline (1800-180-3024).
The letter references a 2022 D.O. from the Ministry of Health Secretary, framing safety monitoring as an ethical imperative under PvPI/MvPI, and a May 15, 2024, DCG(I) circular affirming device regulation under the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017—requiring robust surveillance and MvPI reporting.
MAHs must fully comply by reporting all events—serious/non-serious, expected/unexpected—to NCC-MvPI at IPC, ideally via ADRMS. Proactive reporting strengthens India’s materiovigilance framework, supports timely actions, and ensures devices are safe, effective, and reliable.
The closing excerpt from the IPC letter stresses that proactive, ongoing adverse event reporting by Marketing Authorisation Holders (MAHs) is vital to bolster India’s materiovigilance system. This enables quick regulatory responses and ensures medical devices stay safe, effective, and dependable for patients and healthcare providers. It also offers training support via email at mvpi-ipc@gov.in for better reporting proficiency.