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Review Article

Materiovigilance: An Indian perspective

Bikash Ranjan Meher
Department of Pharmacology, All Indian Institute of Medical Science, Bhubaneswar, Odisha, India

Abstract Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any
untoward occurrences associated with the use of medical devices and protection of patient’s health by
preventing its recurrences. Postmarketing surveillance of medical devices has been initiated in many
countries, but it is still not as developed and robust as that of medicines. Materiovigilance program of India
was launched on July 6, 2015, at Indian Pharmacopeia Commission with objectives to track the adverse
events associated with the use of medical devices, to generate safety data, create awareness among the
different stakeholders, and recommend the best practices and interventions to improve the patient’s safety.

Keywords: Adverse event, medical device, postmarketing, vigilance

Address for correspondence: Dr. Bikash Ranjan Meher, Department of Pharmacology, All Indian Institute of Medical Science, Bhubaneswar, Odisha, India.
E‑mail: [email protected]

INTRODUCTION for an injury, investigation, replacement, modification,

or support of the anatomy or of a physiological process,
Medical devices have an immensely important role in supporting or sustaining life, control of conception,
diagnosis, prevention, and treatment of different diseases.[1,2] disinfection of medical devices providing information by
Recent stride in scientific innovation has substantially means of in vitro examination of specimens derived from
increased the role medical devices in the health‑care the human body; and does not achieve its primary intended
delivery system. There are more than a million medical action by pharmacological, immunological or metabolic
devices available ranging from simple low‑cost bandage means, in or on the human body, but which may be assisted
or tongue depressor to high cost and complex devices in its intended function by such means.”[5]
such as magnetic resonance imaging machine and medical
software application.[3,4] The World Health Organization Although the use of medical devices benefits the patients
has defined medical device as any “instrument, apparatus, immensely, they also carry significant potential risks. There
implement, machine, appliance, implant, reagent for are multiple instances where the device was recalled either
in vitro use, software, material or other similar or related due to defect or because of the significant morbidity and
article, intended by the manufacturer to be used, alone or mortality it caused in the users.[6‑8] Therefore, it is imperative
in combination, for human beings, for one or more of to assess and ascertain the risks and benefits associated with
the specific medical purpose(s) of diagnosis, prevention, the device at all stages of its development and uses. This
monitoring, treatment or alleviation of disease, diagnosis, can be achieved by a robust monitoring mechanism which
monitoring, treatment, alleviation of or compensation at present is followed only in few countries.[9,10]

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DOI:
10.4103/picr.PICR_26_18 How to cite this article: Meher BR. Materiovigilance: An Indian perspective.
Perspect Clin Res 2018;9:175-8.

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Meher: Materiovigilance – An Indian perspective

Postmarketing surveillance practice of device in other MATERIOVIGILANCE PROGRAM OF INDIA

countries
The Unites States pioneered the postmarketing surveillance In India, safety, quality, and performance of medical
of medical devices by enacting the Food and Drug devices are regulated as per Drug and Cosmetic Acts, 1940
Administration  (FDA) Modernization Act 1970 under and Rules, 1945. India did not have a proper system to
section 522 for medical devices. Subsequently, other monitor the adverse events associated with uses of medical
countries such as Australia, Canada, and European Union devices for a long period of time.[17] To regulate the import,
brought out the law for effective surveillance of medical manufacture, sales, and distribution of medical devices,
devices.[11,12] In 1993, initiative was taken to establish Government of India in consultation with Drugs technical
Global Harmonization Task Force (GHTF) by European advisory board has recently brought out Medical Devices
Union, USA, Japan, Australia, and Canada. The aim of Rules, 2017 [Figure 1]. It was notified on January 31, 2017
GHTF was to bring uniformity in regulatory system and came into force from January 1, 2018.[17]
related to safety, performance, and quality of medical
devices.[13] In 2011, a new forum, International Medical Materiovigilance refers to close monitoring of any
Device Regulators Forum (IMDRF) was conceived undesirable occurrences resulting from the use of medical
to build on the commendable work of GHTF and devices by means of having a system in place which
accelerate the medical device regulatory harmonization comprises identifying, collecting, reporting, and estimating
and convergence.[14] undesirable occurrences and reacting to them, or safety
corrective actions after their postmarketing phase.[18,19]
The UK Medical Devices Agency has both vigilance
Drugs Controller General India launched materiovigilance
reporting scheme and the adverse event scheme for the
program of India (MvPI) at Indian Pharmacopeia
postmarketing surveillance of medical devices. Vigilance
Commission  (IPC), Ghaziabad on July 6, 2015. The
reporting scheme is for manufacturers and is mandatory,
fundamental aim of this program is to monitor medical
whereas Adverse Event Scheme is for health‑care providers,
device‑associated adverse events (MDAE), create awareness
hospital engineers, and patients and is voluntary. There is
among health‑care professionals about the importance
prescribed timeline for the manufacturer to report adverse
of MDAE reporting and generate independent credible
events failing which they are levied penalties. Health‑care
evidence‑based safety data of medical devices and to
professionals are obliged to report the adverse event and
share it with the stakeholders.[20] The IPC functions as the
expected to report it immediately.[4]
National Coordination Centre (NCC) and Central Drug
In the United States also mandatory and voluntary Standard Control Organization (CDSCO) functions as the
scheme of reporting is proposed by FDA. Medical Device regulator of MvPI [Figure 1]. The goal of this program is to
Reporting regulation (21CFR 803) contains mandatory initially enroll 10 medical colleges across four parts of India
requirements for manufacturers, importer, and user’s and encourage voluntary reporting, whereas later, it intends
facilities to report certain adverse events and problems to expand the program to all private and public health‑care
delivery system, develop e‑reporting system, and make
pertaining to the use of the devices on FDA Med watch
the reporting mandatory for device manufacturers and
form 3500A or on an electronic equivalent to the FDA.
health‑care providers.
FDA has specified the strict timeline for the manufacturers
and importers of medical devices to submit reports of OBJECTIVES OF MATERIOVIGILANCE PROGRAM
death or serious injury occur due to devices and if devices OF INDIA
have developed any malfunctions. A device user facility also
must report the suspected medical device‑related serious The program was initiated with the objectives to protect
injury or death to both manufactures and FDA within the health and ensure the safety of device users and
the prescribed timeline. It also has to submit the annual others by reducing the recurrences of adverse events and
summary report of death or serious injury in 3419 FDA malfunctions.[20]
form to the FDA.[15] • To create a nationwide system for patient safety
monitoring
USFDA encourage the health‑care providers and device • To analyze the risk–benefit ratio of medical devices
users to report any suspected device‑related injury or uses
adverse effect on FDA 3500 form or using the MedWatcher • To generate evidence‑based data on the safety of
mobile app to the FDA.[16] medical devices

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Meher: Materiovigilance – An Indian perspective

• To support CDSCO in the decision‑making process adverse event report from MDMC and collates, analyze
on the use of medical devices and perform signal detection and communicate the
• To communicate the safety information on the use of outcome to National coordinating centre(NCC). It is also
medical devices to various stakeholders to minimize involved in conducting awareness program, training, and
the risk the workshop on materiovigilance periodically at various
• To emerge as a national center of excellence for zones of the country. At present, Sree Chitra Tirunal
materiovigilance activities Institute for Medical Sciences and Technology (SCTIMST),
• To collaborate with other healthcare organizations and Thiruvananthapuram, functions as National collaborating
international agencies for the exchange of information centre. The main responsibility of Indian Pharmacopoeia
and data management. Commission which functions as MvPI‑NCC is to
coordinates with all stakeholders of the program by
Documenting and reporting adverse events convening steering committee and working group meetings.
All types of adverse events related to medical devices The other responsibility of it is to recognize new MDMCs
used in India irrespective of whether they are known or across the country. It also prepares and disseminates SOP,
unknown, serious or nonserious, frequent or rare can be guidance documents, training manual, and newsletter.
reported. Along with that any malfunction or deterioration It formulates the data received from SCTIMST and
in characteristics or performance of medical device or recommend to the CDSCO for appropriate action.
inaccuracy in labeling or instructions for use can be DGCI‑CDSCO formulates the regulatory decisions and
reported. A reporting format, two pages medical device communicates to the different stakeholders. As regulator, it
adverse event reporting form has been prepared by MvPI is also incumbent upon CDSCO to join IMDRF and other
which contain all information in detail regarding the patient, international forums for exchange of postmarketing safety
adverse event, device, regulator, and reporter. This form information. National Health System Resource Centre
is freely available on the official website of IPC (www.ipc. Ministry of Health and Family Welfare, Government of
gov.in). The duly signed form can be sent to the nearest India, New Delhi, functions as TSRC. It provides technical
medical device monitoring center (MDMC) or can be support to NCC and National Coordination Centre for the
directly sent to the National Collaborating Center (NCC). preparation of SOP, guidance documents, newsletters, and
It can also be scanned and mailed @sctismt.ac.in and copy training manuals. It also helps in identifying new MDMC.
to [email protected]. The reporter can also call the
helpline number created by NCC‑PvPI (1800‑180‑3024) CONCLUSION
and report the adverse event. Documenting and reporting
There is an upsurge in the use of medical devices in
adverse events due to the device and seamless flow of
recent years. Despite that, there are not adequate measures
information involves various aspects and interrelationship
to protect the patients from the untoward occurrences
among different stakeholders.
• Role of health‑care service providers
• Role of manufactures Medical Device Adverse Event Monitoring
• Role of research associate and coordinator at MDMC Centre(MDMCs)

• The responsibility of National Collaborating Centre

• The responsibility of National Coordinating
Centre(NCC) Sree Chitra Tirunal Institute for Medical Sciences and Technology(STIMST),
Thiruvananthapuram
• The responsibility of technical support and research (National Collaborating Centre)

center (TSRC)
• The responsibility of CDSCO.

Role and responsibilities of different units of Indian Pharmacopeia Commission, Ghaziabad

National Coordinating Centre(NCC)
National Health System Resource
Centre(NHSRC) Ministry of Health and Family
materiovigilance program of India Welfare,Govt of India, New Delhi
Technical Support and Research
MDMC collect and review the completeness of MDAE, Centre(TSRC)

analyze failure mode effect, assess causality as per the

standard operating procedures (SOP), and send the monthly
consolidated report to National collaborating centre. As
per the guidance documents of MvPI 10 medical colleges Central Drug Standard Control Organisation, New Delhi
(National Regulatory Authority)
in different parts of the country has been identified as
MDMC. The National collaborating centre receives the Figure 1: Organisational structure of materiovigilance program of India

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Meher: Materiovigilance – An Indian perspective

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