New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has released a detailed Risk Classification List of Class A (non-sterile and non-measuring) medical devices, providing regulatory clarity for manufacturers and importers.

The notification, issued under file number F. No. MED-16014(12)/1/2024-eoffice-Part(2), outlines the categorization of hundreds of low-risk medical devices such as surgical instruments, dental tools, orthopaedic aids, and diagnostic accessories.

As per the note to stakeholders, all Class A (non-sterile and non-measuring) devices are exempt from several provisions of the Medical Devices Rules, 2017—including Chapters IV, V, VII, VIII, and XI—provided that manufacturers and importers register these devices under Chapter IIIB.

S. No.

Device Name

Intende

See Full Page