CDSCO Launches Separate Online Provision for Subsequent Importers of Medical Devices, IVDs
New Delhi: With an aim to streamline the regulatory process for the import of medical devices and in vitro diagnostics (IVDs), the Central Drugs Standard Control Organization (CDSCO) has announced the launch of a new provision in its online portal.
The feature, effective from September 11, 2025, allows subsequent importers to apply separately for devices already approved by the Central Licensing Authority under the Medical Devices Rules, 2017.
In order to simplify the regulatory approval procedure, the CDSCO has initiated various steps to bring more transparency and accountability to the regulatory system. Several 'Tool Tips' have been published on the CDSCO website to give more clarity on the technical requirements, etc., while making applications in the portal for regulatory approval.
The procedure for 'Brand Approval' has been simplified with minimum requirements and separated from the routine endorsement applications with the objective to reduce processing timelines and facilitate expedited approval.
Now, a separate provision for 'Subsequent Importer' has been made functional w.e.f. 11.09.2025 in the CDSCO online portal (https://cdscomdonline.gov.in) for the import of already approved Medical Devices and In-vitro diagnostics (IVD) by the Central Licensing Authority under the Medical Devices Rules, 2017.
"In view of the above, the applicant who intends to import Medical Devices and IVDs which are already approved by the Central Licensing Authority for marketing in the country may submit their application for import of such devices as a subsequent importer as per the checklist provided for the said purpose," the circular stated.
The circular has been circulated to all stakeholders through the CDSCO website, with copies also shared with State and UT Licensing Authorities, CDSCO zonal and port offices, and the IT/ CDAC team for implementation.
To view the official notice, click the link below
https://medicaldialogues.in/pdf_upload/subsequent-importer-applications-301140.pdf
