Section 109B in The Drugs and Cosmetics Rules, 1945
109B. [ Exemption of certain labelling requirements for medical devices for export from India. [Inserted by Notification No. G.S.R. 690 (E) dated 25.9.2014 (w.e.f. 21.12.1945)]
- The labels on packages or container of devices for export shall be adopted to meet specific requirements of the law of the country to which the device is to be exported, but the following particulars shall appear in conspicuous manner on the label of the 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 preceded by the word "Lot No." or "Lot" or "Batch No." or "B.No.";(c)the date of expiry, if any;(d)the name and address of the manufacturer and address of actual premises where the device has been manufactured;(e)the manufacturing License No. preceded by the letters "M.L. No" or "Manufacturing License No.";(f)the internationally recognized symbols in lieu of text, wherever required:Provided that where a device is required by the consignee not to be labelled with the name and address of the manufacturer, the label on the packages or container shall bear a code number as approved by the 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 license number:Provided further that where a device is required by the consignee not to be labelled 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 licensing authority under rule 21.
