Schedule 1 Notified Devices
This page provides an overview of this Schedule of the Medical Devices Rules 2017 and links to the official text.
Official source: MDR 2017 β CDSCO
Schedule 1 of MDR 2017 lists notified medical devicesβdevices that require specific regulatory approvals, licenses, or registrations before import or manufacture in India. These devices typically include Class III and certain Class II devices, as well as devices with specific safety or efficacy concerns. Manufacturers and importers must check this schedule to determine which of their products require CDSCO approval. The list is updated periodically through amendments to MDR 2017.