Last Updated on October 9, 2024 by The Health Master
Download the updated list of medical device testing laboratories (MDTLs) as on 21, 2022. The link is given below: The Central Drugs Standard Control Organization (CDSCO) has approved four more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluations 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, 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 the approval to conduct tests on 15 devices, Shree Balaji Test Lab has approval for 14 devices, Interstellar Testing Centre has approval for testing 24 devices, and Yadav Measurements has approval for nine devices.
The number of MDTLs has increased from 18 on December 7, 2021, to 24 on August 17, 2022, and to 28 now.
The expansion of medical device testing laboratories is critical given the country’s growing medical device industry and increased regulatory control over the industry for the growth of the devices market, with an emphasis on the 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 medical devices is expected to be in place in the near future and that faster processing of tests in laboratories would play a major role in taking the products to 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.
According to Union Minister for Science and Technology Dr. Jitendra Singh, India is among the top five countries in the world for manufacturing life-saving high-risk medical devices, and the cost of Indian devices is about one-third of those manufactured by other countries.
World-class medical devices made indigenously are available to Indian patients at approximately one-fourth to one-third the price of their imported counterparts.
The Atma Nirbhar vision of Prime Minister Narendra Modi is to make India self-reliant in medical devices as well as medical management.
He said that it was Prime Minister Modi, who notified the Medical Devices Rules in 2017 in conformity with the Global Harmonization Task Force (GHTF) framework and best international practices.
The new rules aim to remove regulatory barriers to manufacturing in India, make doing business easier and ensure the availability of better medical devices for patient care and safety.
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