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Materiovigilance
programme of India and its reporting tools
Medical Device Adverse Event Monitoring Centers (MDMCs)
have been established to create awareness about the
program and enhance the quality of reporting. Under MvPI,
a total of 387 MDMCs have been identified in the country
to report the adverse events associated with the use of
medical devices and mandates through the NABH
accreditation standard for hospitals and small healthcare
organizations. A standard reporting format called ‘Medical
Device Adverse Event Reporting Form’ \ Medical Device
Adverse Event Reporting Form-Hindi has been developed by
IPC for collecting and monitoring adverse events
associated with medical devices and IVDs.
A Field Safety Corrective Action (FSCA) form is also
developed for reporting alerts and product recalls by the
manufacturers or importers to reduce the risk of death or
serious health deterioration associated with the use of a
medical device that is already on the market. It is
mandatory to report as per the Medical Device Rules of
2017. Please find FSCA Form from IPC Website.
The current reporting structure shows that NCC-MvPI and
IPC collected more than 18,738 reports, of which
approximately 50% of incidents are reported by healthcare
professionals, 24% of adverse events are reported by
manufacturers, 10% of issues are reported by importers,
and 8% of them are reported by distributors, and 8% of
near-miss incidents are reported by patients, consumers,
and end users.
Through this article, NCC-MvPI IPC expects valuable
support in reporting incidents, alerts, and product
recalls as part of regulatory compliance for reporting
incidents within 30 days and for non-serious incidents and
reporting of serious incidents within 15 calendar days.
Who can report?
Any Manufacturer, Importer, Distributor, healthcare
professionals such as Doctors, Nurses, Technicians, Lab
assistants, Hospital/Lab administrators, Patients & the
General public can report to NCC-MvPI, IPC, or nearest
AMCs under PvPI/MDMCs under MvPI.
What to report?
Any adverse events or near-miss incidents due to medical
devices or IVD can be reported. The information obtained
by performing device testing by the manufacturer, user, or
other party may include:
a) A malfunction or deterioration in the characteristics
or performance of the medical device
b) An incorrect or out-of-specification test result
c) The discovery of a design flaw during design review
d) An inaccuracy in labelling, instructions for use and/or
promotional materials. Inaccuracies include omissions and
deficiencies. Omissions do not include the absence of
information that should generally be known by the intended
users
e) The discovery of a serious public health threat. This
may include an event that is of significant and unexpected
nature and is a potential public health hazard, e.g. Human
Immunodeficiency Virus (HIV) or Creutzfeldt-Jacob Disease
(CJD).
f) Increase in user error or application error with the
medical device
g) Any other information (Recall or field corrective
notice) made available by medical device regulators in
other countries for the same product
h) Information available by way of literature, scientific
documentation, or increase in complaint trend
How & where to report?
NCC-MvPI has developed the following modalities to report
incidents associated with medical devices:
1. Medical Device Adverse Event (MDAE) Reporting Form to
report incidents involving medical equipment or devices,
its consumables, IVDs, implants, consumables, surgical,
etc.:
https://www.ipc.gov.in/mandates/materiovigilance-programme-of-india-mvpi/mvpi-toolkit.html
2. Marketing authorization holders have to report alerts
and product recalls as regulatory compliances as mentioned
in Medical Device Rules 2017. Please find Field Safety
Corrective Action (FSCA) form:
https://ipc.gov.in/images/FIELD_SAFETY_CORRECTIVE_ACTION_NOTIFICATION_FSCA_FORM.pdf
3. End user can also report through Toll-free Helpline No.
18001803024 (Monday to Friday 9:00 am to 5:30 pm)
4. Stakeholders can report through the PvPI mobile
application. (download from Play store) or through ADRMS
Software:
https://adrmsipc.in/adrms/index.html
The filled Reporting form can be forwarded to
Shatrunjay.ipc@gov.in
or mvpi-ipc@gov.in
For more information, kindly visit the website:
https://www.ipc.gov.in/mandates/materiovigilance-programmeof-india-mvpi/about-us.html
https://nhsrcindia.org/hc-technology/materiovigilanceprogramme-of-indi |
