Separate provision for subsequent Importer in Online system for Medical Devices

On 15 September 2025, CDSCO announced a new provision in its online portal for subsequent importers of medical devices and in-vitro diagnostics (IVDs) already approved by the Central Licensing Authority under the Medical Devices Rules, 2017. This functionality, effective from 11 September 2025, is designed to streamline the regulatory process, improve transparency, and reduce approval timelines. The circular also highlights other recent initiatives, such as simplified brand approval procedures and the publication of tooltips for better clarity on technical requirements. Applicants intending to import approved devices can now submit their applications as subsequent importers using the dedicated checklist available on the CDSCO portal (https://cdscomdonline.gov.in).