45. Exemption of labeling requirements for export of medical devices.
- The labels on packages or container of devices for export shall be adopted to meet the specific requirements of law of the country to which the device is to be exported, but the following particulars shall appear in a conspicuous manner on the label of the inner most pack or shelf pack of the medical device in which the device is packed and every other outer covering in which the container is packed:-(a)name of the device;(b)the distinctive batch number or lot number or serial number preceded by the word "Lot No." or "Lot" or "Batch No." or "B. No." or "Serial No.";(c)date of expiry, if any;(d)the name and address of manufacturer and address of actual premises where the device has been manufactured;(e)licence number preceded by letters "Licence No. or Lic. No.";(f)internationally recognized symbols in lieu of text, wherever required:Provided that where a device is required by the consignee not to be labeled with the name and address of manufacturer, the label on the package or container shall bear a code number as approved by the Central Licensing Authority and the code number shall bear the name of the State or Union territory, in abbreviation, followed by the word "Device" and "manufacturing licence number":Provided further that where a device is required by the consignee not to be labeled with the code number also, the label on the packages or container shall bear a special code number, as requested by the consignee, and approved by the Central Licensing Authority.
