CDSCO Launches National Single Window System Portal

LegalitySimplified

Central Drugs Standard Control Organization (CDSCO) has launched a National Single Window System (NSWS) Portal. This portal has been designed to build a system that functions as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business. A notice on this system was issued on January 1, 2024.

The NSWS Portal for CDSCO will be independent of the SUGAM Portal or the cdscomdonline portal. From January 1, 2024, the following three activities under the Medical Devices Rules, 2017 will be made live on the NSWS Portal:

  • application for grant of certificate of registration of a notified body- Form MD -01
  • application for licence to manufacture medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -12
  • application for licence to import medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -16

Hence, all concerned stakeholders shall submit the above applications only through the NSWS Portal. The existing cdscomdonline portal for these activities will be disabled from January 15, 2024.

The notice also include a user guide to help facilitate the transition to the NSWS Portal.

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