Launch of NSW Portal for Medical Devices
Central Government has launched a ‘one-stop-shop’ portal NSWS, designed by Invest India through Tata Consultancy Services (TCS) to streamline the import of medical devices in the country. This will be independent of the existing portals – the SUGAM portal or cdscomdonline portal. The existing portals will be disabled by January 15, 2024
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.
From January 1, 2024, the following three activities under the Medical Devices Rules, 2017 will be made live on the NSWS Portal:
i. application for grant of certificate of registration of a notified body- Form MD -01
ii.application for licence to manufacture medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -12
iii.application for licence to import medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -16
All the stakeholders should submit the application for the above 3 activities, through NSWS portal only
Click the link below to read the detailed guide book on How to apply for CDSCO approval