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 — CDSCO

Schedule 1 of MDR 2017 lists notified medical devices—devices subject to mandatory regulatory approval by CDSCO before import or domestic manufacture in India. These devices typically include Class III and higher-risk Class II devices, as well as devices with specific safety, efficacy, or public health concerns identified by CDSCO. 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.

Schedule 1 of MDR 2017 lists notified medical devices—devices 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.