CDSCO has been simplifying regulatory procedures through portal-based approvals, tooltips, and faster brand approvals. To further improve efficiency and transparency, a separate online system has now been introduced for subsequent importers of already approved medical devices and IVDs.

1. A separate provision for “Subsequent Importer” has been made functional in the CDSCO online portal (https://cdscomdonline.gov.in) with effect from September 11, 2025.
2. This provision applies to import of medical devices and in-vitro diagnostics (IVDs) which are already approved by the Central Licensing Authority under the Medical Devices Rules, 2017.
3. Applicants intending to import such devices must submit their applications under the new “Subsequent Importer” category available in the portal.
4. A specific checklist for “Subsequent Importer” applications has been provided by CDSCO for this purpose, which must be followed while filing applications.
5. This provision is distinct from routine endorsement applications and the earlier brand approval process.