- The shelf life of the medical devices, shall be determined keeping in view the technical parameters and shall ordinarily not exceed sixty months from the date of manufacture to be reckoned from month to month (i.e. January to January), except in cases where satisfactory evidence is produced by the manufacturer to justify a shelf life of more than sixty months of a device to the satisfaction of the Central Licensing Authority:Provided that any medical device, whose total shelf life claim is less than ninety days, shall not be allowed to be imported by the licensing authority if it has less than forty per cent. residual shelf-life on the date of import:Provided further that any medical device, whose total shelf life claim is between ninety days and one year, shall not be allowed to be imported by the licensing authority if it has less than fifty per cent. residual shelf-life on the date of import:Provided also that any medical device, whose total shelf life claim is more than one year, shall not be allowed to be imported by the licensing authority if it has less than sixty per cent. residual shelf-life on the date of import.
