The document discusses India's Materiovigilance programme which monitors incidents involving medical devices. It was established to improve device quality and safety after incidents like incubator fires led to infant deaths. The programme coordinates various centers to collect, analyze and signal adverse event reports which help regulators take action. It aims to constantly enhance medical device oversight and protect patients.

1. Materiovigilance

2. Materiovigilance
Study and follow incidents that might result
from using medical devices.
It enables dangerous devices to be
withdrawn from the market and to eliminate
faults in medical devices
Intention of constantly improving the quality
of devices and providing patients and users
with increased safety.

3. Medical device is defined as any instrument, equipment,
material or other article used on its own or jointly, including
software required for it to function correctly, which is intended
by the manufacturer to be used on humans for the following
purposes :
for diagnostic, prevention, control, treating or diminishing an
illness
for diagnostic, control, treating, for diminishing or
compensating an injury or handicap,
for studying, replacing or modifying part of the anatomy or a
physiological process
 for mastering conception and whose principal intended
action in or on the human body is not obtained by
pharmacological or immunological means or by metabolism
but whose function can be assisted in such a way.
Materiovigilance

4. ➢Medical Devices come under Schedule R1.
➢At present, provisions related to import,
manufacture, distribution and sale of medical
devices are covered under the Drugs and
Cosmetics Act, 1940 and the Drugs and
Cosmetics Rules, 1945
Materiovigilance

5. ➢ After several horrific cases of malfunctioning
medical devices, like babies being burnt to death due
to short circuits in incubators or hip implants
causing blood poisoning etc.
➢The Ministry of Health and family Welfare
(MoHFW) has approved a commencement of
“Materiovigilance Programme of India (MvPI)”
vide approval dated 10/02/2015 in an effort to
ensure safety of medical devices.
Materiovigilance

6. 6
24 infants died in the
space of 72 hours in two
government hospitals of
Murshidabad in West
Bengal-Jul 17, 2011
Three-day-old killed after
incubators caught fire in a
hospital in Ahmedabad. -
December 2008
Five newborns
receiving treatment for
jaundice at a
government hospital in
northern India died as a
fire broke out in its
phototherapy unit. Nov
16, 2009
Need for MvPI ?
An 8-minute power
cut at a premier
hospital in
Punducherry ended
in the loss of three
lives -09/03/2017

10. Materiovigilance programme of
India
MvPI

11. Scope
 To analyse the benefit-risk ratio of medical devices
 To generate evidence based information on safety
of medical devices
 To support CDSCO in the decision-making
process on use of medical devices
 To communicate the safety information on use of
medical devices to various stakeholders to minimise
the risk.
 To collaborate with other healthcare organisations for
the exchange of information and data management.

12. 1. PGIMER, Chandigarh
2. CMC Vellore
3. AIIMS, New Delhi
4. Dayanand Medical College and Hospital, Ludhiana
5. National Institute of Mental Health And Neurosciences
(NIMHANS), Karnataka
Medical Device Adverse Event
Monitoring Centers (MDMCs)

13. 6. Glocal Group of Hospitals, Kolkata
7. Narayna Hrudalaya Hospital, Bengaluru
8. Jawaharlal Institute of Postgraduate Medical
Education and Research (JIPMER), Puducherry
9. Sanjay Gandhi Post Graduate Institute of Medical
Science, Lucknow
10.Bankura Sammilani Medical College, West Bengal
Medical Device Adverse
Event Monitoring Centers
(MDMCs)

14. Programme Communication
CDSCO-Headquarter,
New Delhi
National Coordination Centre
IPC, Ghaziabad
Technical
Support &
Resource
Centre
NHSRC,
New-Delhi
National
Collaborati
on Centre
SCTIMST,
Kerala
AMCs/MDMCs
Healthcare Professionals
CDSCO Zonal / Subzonal
Offices
Medical Device
Industries in India
Steering
Committee
Working
Group
Core
Technical
Committee

15. Medical Device Adverse Event
Monitoring Centers (MDMCs)
Roles and responsibilities
▶ Each MDMC under MvPI is assigned with a coordinator and
a Research Associate responsible for its functioning .
▶ The coordinator is responsible for sending the consolidated
monthly reports of its MDMC to NCC.
▶ The Research Associate is responsible for collection and
follow-up of MDAEs. All MDAE reports have to be sent to
National Coordination Centre (NCC) for review and
analysis.
▶ Feedback to all healthcare professionals involved in
reporting is to be sent by the Coordinator.

16. GNS-IPC,GZB
1
6
1
6
Indian Pharmacopoeia Commission

17. Roles and responsibilities
▶ IPC functions as National Coordination Centre (NCC)
for MvPI.
▶ The main responsibility of NCC is to coordinate with all
partners of the programme.
▶ Organising various meetings like steering committee,
working group, core technical committee meetings etc.
▶ Recognition of new Medical Device Adverse Event
Monitoring Centres (MDMCs) of public and private
hospitals across the country.
Indian Pharmacopoeia Commission
(IPC)

18. Roles and responsibilities contd....
▶ Recruitment and deployment of manpower (All MvPI staff
shall be appointed & work under the administrative control
of NCC-PvPI).
▶ Data collection, collation, analysis and signal detection and
outcome to be communicated to CDSCO for relevant
regulatory actions.
▶ IPC is the sole Custodian for MvPI database.
▶ Publication and dissemination of standard operating
procedures, guidance documents, newsletters, training
manuals etc. with technical support from NHSRC and
SCTIMST.

19. ▶ Reporting all concerned issues to CDSCO
▶ Collaborating with International Authorities
▶ Issue of medical device alert for awareness and knowledge
▶ Providing financial support to SCTIMST, NHSRC and
MDMCs.
▶ Providing financial support to organise MvPI awareness
program across the country
Roles and responsibilities contd....

20. Sree Chitra Tirunal Institute for Medical Sciences
and Technology (SCTIMST)

21. Roles and Responsibilities
▶ SCTIMST, as the National Collaboration
Centre,
shall support the programme in all technical
matters.
▶ Responsible to collaborate with NCC-PvPI for further
follow-up/ analysis in case of Serious Adverse Event with
MDMCs.
▶ Lend Technical support for organising programme,
continuous professional development education on
Materiovigilance as and when considered necessary by
NCC-MvPI.
Sree Chitra Tirunal Institute for Medical
Sciences and Technology (SCTIMST)

22. ▶ To provide research & development/ testing support
facilities to the programme.
▶ To provide technical support in data
analysis and release of medical device alerts.
Roles and responsibilities contd....

23. National Health System Resource Centre
(NHSRC)

24. Roles and responsibilities
▶ The Healthcare Technology Division of NHSRC
as a technical support partner for MvPI.
acts
▶ To provide technical support/guidance on preparation/ review
of standard operating procedures, guidance documents,
newsletters, training manuals etc.
▶ Lend Support to NCC-PvPI in identification of new MDMC.
▶ Lend Technical support on the activities of National
Collaboration Centre and National Coordination Centre
including training programme.
National Health System Resource
Centre (NHSRC)

25. ▶ Drafting documents for the MvPI related
activities.
▶ Explore possibility of integrating data
mining/ data analytics, to adverse event
reports.
▶ Provide technical advice on setting-up
of
online adverse events data collection and
release of medical device alerts via
Email/SMS etc.
Roles and responsibilities contd....

26. program among
▶ Lend support for creating
medical
awareness
device
manufactures /healthcare organisation.
▶ NHSRCshall also coordinate with other
partners as per need.
Roles and responsibilities contd....

28. Roles and responsibilities
▶ The CDSCO is the National Regulatory Authority
ensure safety, efficacy and quality standards of
pharmaceuticals, medical devices and vaccines.
▶ Responsible for taking appropriate regulatory
decisions/related actions based on the
recommendation NCC- MvPI.
Central Drugs Standard Control
Organization (CDSCO)

29. ▶ Lend support to NCC-MvPI in sharing
International information Medical Device
Regulators
Harmonization
Forum (MDRF), Asian
Working Party (AHWP) and
other forums organised by regulatory bodies
of other countries.
▶ Shall convene meetings with the NCC- MvPI,
SCTIMST & NHSRC for monitoring, review and
further advice on medical devices safety.
Roles and responsibilities contd....

30. ▶ Auditing/ inspecting of MDMCs and National
Collaborating Centre from time to time
▶ Providing administrative support to run MvPI.
Roles and responsibilities contd....

31. ▶ Identification and recognition of Ten Medical Device
Adverse Event Monitoring Centres (MDMCs) across
the country.
▶ Constituted steering committee and working group
and conducted two meetings of both.
▶ Medical Device Adverse Event (MDAE) reporting
form developed
▶ Guidance document for Materiovigilance
Programme of India (version 1.0) prepared in
consultation with NHSRC and SCTIMST
The progress made till date

32. ▶ Recruitment of 05 Research Associates
completed & remaining 10 posts are under
process
▶ Interactive meeting held with Medical Device
manufacturers and Associations
▶ Various review meetings held with the MvPI
partners
▶ Till date, NCC has received more than 200
MDAE reports
The progress made till date
contd....

33. Who can
Report?
Materiovigilan
ce

34. Clinicians
Nurses
Technicians
biomedical
engineers, clinical
engineers, hospital
technology
manager
Medical device
manufacturers/CDSCO
notified medical device
manufacturers/ medical
device importer - trader
Materiovigilance
Materiovigilan
ce

35. Why to
Report?
Materiovigilan
ce

36. What to report
?
Materiovigilan
ce

37. What to report
?
 Dysfunction or any change of the
characteristics and/or performance of a device
 Inadequacy in the labeling or instructions
 Not only serious incidents but also the
cases where there was a risk of a serious
incident but that incident was avoided due to
the attention and action of the relevant people
Materiovigilan
ce

38. Materiovigilan
ce

39. Materiovigilan
ce

40. EXAMPL
ES:
• A batch of out-of-specification blood
glucose test strips is released by
manufacturer
• Patient uses strips according to
instructions, but readings provide
incorrect values leading to incorrect
insulin dosage, resulting in
hypoglycaemic shock and
hospitalization.
Materiovigilan
ce

43. How and Whom to
report ?

49. Types of Medical device adverse event
Reports received at NCC-MvPI
Materiovigilance program of India * 49