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The Drug Controller General of India (DCGI) has directed the laboratories which have capacity for testing medical devices, with adequate quality accreditation, to submit applications to strengthen the medical devices testing laboratories (MDTLs) network in the country, even as the medical devices are in the phase of entering the licensing regime.
So far it has more than 28 laboratories registered with the office for testing purposes. The DCGI's office is receiving the applications for registration under Medical Devices Rules (MDR), 2017 from various laboratories for testing of different medical devices, said the regulator.
"In order to enhance the testing capacity of medical devices in the country, identification, registration and empanelment of government, private testing laboratory for medical devices testing is under consideration as per the MRD 2017," said a notice issued by V G Somani, DCGI.
In this regard, the DCGI requested the laboratories which have capacity for testing medical device and are accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), a constituent Board of Quality Council of India, to submit the application in Form MD-39 along with requisite fees and documents through online portal for further necessary action.
The request comes in continuation with the Central Drugs Standard Control Organisation's previous notice a year back seeking the laboratories to intimate the regulator regarding their capacity for testing of medical devices.
In a notice issued on October 14, 2021, it asked that the eligible laboratories which are interested in the process of testing medical devices, to submit the information along with details of categories of such medical devices and capacities and capabilities of testing to CDSCO for initiating further examination and communication in this regard.
The industry has been demanding 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 CDSCO, in November, this year, approved four medical devices testing laboratories (MDTLs) to carry out tests or evaluation of medical devices on behalf of the manufacturers under the provisions of MDR, 2017.
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.
The current market size of the medical devices sector in India is estimated to be around $11 billion and the sector in India is at a growth stage with a CAGR of 10-12 per cent 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.
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