The Central Drugs Standard Control Organisation (CDSCO) has announced a new measure to streamline the regulatory approval process for importing medical devices and In-vitro diagnostics (IVDs). Effective September 11, 2025, a separate provision for “Subsequent Importer” has been made functional within the CDSCO online portal.
This initiative is part of the CDSCO’s ongoing efforts to simplify procedures, enhance transparency, and increase accountability within the regulatory system. The new provision is specifically designed for applicants who wish to import medical devices and IVDs that have already received marketing approval from the Central Licensing Authority under the Medical Devices Rules, 2017.
Context of Regulatory Simplification
The CDSCO has been actively working on various steps to facilitate expedited approvals and reduce processing timelines. These include publishing “Tool Tips” on the CDSCO website to provide clarity on technical requirements for applicants and simplifying the procedure for “Brand Approval,” which has been separated from routine endorsement applications.
With the introduction of the Subsequent Importer provision, applicants intending to import already-approved devices are advised to submit their applications through this new pathway, following the specific checklist provided for this purpose. This is expected to further simplify the process for importing devices that are already established in the Indian market.