46. Unique device identification of the medical device.
- With effect from 1st day of January, 2022, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification which shall contain device identifier and production identifier.Explanation. - For the purposes of this rule,-(i)"device identifier" means a global trade item number;.(ii)"production identifier" means a serial number, lot or batch number, software as a medical device version, manufacturing and or expiration date.
