India Launches Single-Window Portal Designed by TCS to Streamline Imports of Medical Devices

India has launched a ‘one-stop-shop’ portal designed by IT major Tata Consultancy Services (TCS) to streamline the import of medical devices in the country. India’s apex drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), launched the portal called ‘National Single Window System (NSWS)’.

The portal facilitates applications for the certificate of registration and licences to manufacture or import medical devices for various purposes such as clinical investigations, tests, evaluations, demonstrations, or training.

The letter written by the body on January 1, accessed by News18, said that NSWS has been established by the central government to build a “genuine single-window system which acts as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business.”

“The scope of NSWS includes all the approvals/licenses/registrations/clearances as applicable,” said the letter.

It said that ‘Invest India’, through software firm TCS, has developed NSWS for CDSCO, which will be independent of the existing portals – the SUGAM portal or cdscomdonline portal. The existing portals will be disabled by January 15, the letter said.

Invest India is the National Investment Promotion and Facilitation Agency that helps investors looking for investment opportunities and options in India.

The website has been launched with effect from January 1, but will initially be used for conducting three activities under the Medical Devices Rules, 2017.

Presently, it will be used for applying for the grant of a certificate of registration. It will also be used for applying for a licence to manufacture a medical device for clinical investigations, tests, evaluation, examination, demonstration or training.

The letter added that the portal will be used for applying for a licence to import medical devices for clinical investigations or tests or evaluations or demonstrations or training. In the coming months, the addition of more such activities is expected.

“In a couple of months, every activity related to medical devices will be moved to the new website. The idea is to streamline the import of medical devices in India and on the other, provide ease of doing business to med-tech companies selling devices on our land,” said a senior official from the Ministry of Health and Family Welfare, requesting anonymity.