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CDSCO Approves Four More
Medical Device Testing Labs
The Central Drugs Standard
Control Organisation (CDSCO) has approved four more
Medical Device Testing Laboratories (MDTL) to carry out
tests or evaluation of a medical device on behalf of the
manufacturers under the provisions of the Medical Devices
Rules, 2017. With this, the total number of MDTLs approved
by the regulator is 28 across the country.
The newly added laboratories include TUV Rheinland (India)
Pvt Ltd, in Andhra Pradesh Medtech Zone Ltd, Visakhapatnam,
Andhra Pradesh, Shree Balaji Test Lab Pvt Ltd, situated at
Naraina Industrial Area Phase-I, New Delhi, Intersteller
Testing Centre Pvt Ltd at Panchkula Industrial Area,
Haryana, and Yadav Measurements Pvt Ltd at RIICO Bhamashah
Industrial Area, Udaipur, Rajasthan.
TUV Rheinland has approval to conduct tests on 15 devices,
Shree Balaji Test Lab has approval for 14 devices,
Intersteller Testing Centre has approval for testing 24
devices and Yadav Measurements for nine devices.
The number of MDTLs has increased from 18 registered till
December 7, 2021 to 24 registered on August 17, 2022 and
to 28 laboratories now. The expansion of medical devices
testing laboratories is important considering that the
country is looking at a growing medical devices industry
and increased regulatory control over the industry for the
growth of devices market with emphasis on quality and
safety of the devices.
The government, while announcing the Medical Devices
Rules, 2017, said that a network of NABL accredited
laboratories will be set up both, by the Government and by
other entities, for testing medical devices.
Experts opine that there should be a faster expansion of
the approved laboratories for testing, considering that
the licensing regime for a majority of the medical devices
are expected to be in place in the near future and faster
processing of tests in laboratories would play a major
role in taking the products to the market without delay.
The current market size of the medical devices sector in
India is estimated to be $11 billion and the sector in
India is at a growth stage with a CAGR of 10-12% over the
last decade and has the potential to reach $50 billion by
2030.
India is among the top five countries in the world
manufacturing life-saving high risk medical devices and
the cost of the Indian devices is about one-third of those
manufactured by some of the other countries, said Union
minister for science and technology Dr Jitendra Singh
recently.
The world class medical devices made indigenously are
available to Indian patients at approximately one fourth
to onethird price of their imported counterparts. The Atma
Nirbhar vision of Prime Minister Narendra Modi is to
become self-reliant in medical devices as well as medical
management.
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