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.

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Dr. VG Somani, DCGI CDSCO

"In order to enhance the testing capacity of medical devices in the country, identification, registration, and empanelment of government, private testing laboratories for medical device testing are under consideration as per the MDR 2017," said a notice issued by Dr. V G Somani, DCGI.

In this regard, the DCGI requested the laboratories that have the capacity to test medical devices and are accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), a constituent board of the Quality Council of India, submit the application in Form MD-39 along with the requisite fees and documents through the online portal for further necessary action.

The request comes in continuation with the Central Drugs Standard Control Organisation's (CDSCO) previous notice a year ago seeking the laboratories to inform the regulator regarding their capacity for testing medical devices.

In a notice issued on October 14, 2021, it asked that the eligible laboratories that are interested in the process of testing medical devices submit the information, along with details of the categories of such medical devices and capacities and capabilities of testing, to CDSCO for initiating further examination and communication in this regard.

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The industry has been calling for a faster expansion of approved testing laboratories, given that the licensing regime for the majority of medical devices is expected to be in place soon, and faster processing of tests in laboratories would play a significant role in getting products to market as soon as possible.

The CDSCO, in November, this year, the CDSCO approved four medical devices testing laboratories (MDTLs) to carry out tests or evaluations of medical devices on behalf of the manufacturers under the provisions of MDR, 2017.

The number of MDTLs has increased from 18 registered until 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.

Medical Device Testing Laboratories (MDTLs)

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 percent 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.

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