The Central Drugs Standard Control Organisation (CDSCO) on November 26, 2025, issued a notice classifying medical devices related to Radiotherapy under the Medical Devices Rules, 2017. Acting under Rule 4(3), the authority finalized the classification following the earlier publication of a draft list on January 6, 2025. The notice formally places the risk-based classification list in Appendix A, covering radiotherapy devices intended for manufacture or import.
CDSCO clarifies that the general intended use listed for each device is meant to guide applicants submitting applications under the Medical Devices Rules, 2017; however, manufacturers may specify different or more specific intended uses for their devices. The classification framework ensures clarity for regulatory submissions and compliance requirements.
The notice further emphasizes that the list is dynamic and may be revised periodically in accordance with the Medical Devices Rules, 2017, reflecting technological advancements or regulatory needs.
[File No. MED-16014(12)/1/2024-eoffice]
