Labeling regulations promulgated for the medical devices under Medical Devices Rules 2017, are found in Chapter VI from Rules 44 to Rules 48. Label is defined as the display of written, printed or graphic matter upon the immediate container of any article. Labeling is the broader term that includes the label and the descriptive and informational literature that accompanies the device. It includes equipment labels, control labels, package labels, instruction for use, maintenance manuals, technical description, intended purpose and proper use of the medical device. Labeling helps to identify a device and its manufacturer and it acts as a way to communicate the information related to its safety, efficacy and use. The intended user may be professional or lay persons and relevant third parties.
The following particulars must appear on label, on the shelf pack or on the outer covering and on every outer covering in which the device is packed, namely: (1) name of the device, (2) name and address of the manufacturer (and importer, if applicable), (3) month and year of manufacture, (4) expiry or shelf life, (5) batch or lot number, (6)manufacturing or import licence number, (7) quantity of the device in the package, (8) net quantity in terms of weight, measure, volume, number of units, (9) number of the devices contained in the package in metric system, and (10) an indication whether the device is intended for single use. These details should be included mandatorily even in small medical devices, where the rest of the information mentioned below can’t be printed legibly. The net quantity of contents also enables the consumer to compare the contents in terms of value.
For sterile devices, the sterile state and sterilization method should be indicated and for devices with medicinal and biological substances, such substances should be mentioned in the label. If the device is meant for single use, or given as a free sample to medical professional, the same should be indicated on the label. Warnings, precautions, special storage condition and the details necessary for the user to identify the device and its use should be included in the label.
The symbols recognized by the BIS or ISO may be used in place of text provided its meaning is obvious to the device user.
Expiry date
The date of expiry should be preceded by the words “Expiry date” or “Shelf Life” following which the month and year of expiry should be mentioned. In case of sterile devices, the date of sterilization may be given as date of manufacture of the device. For devices with stable materials like stainless steel or titanium, which are supplied as non-sterile or in case of medical equipment or instruments or apparatus, the date of expiry may not be necessary.
The shelf life of the medical device is based on its technical parameters and should not exceed sixty months from the date of manufacture (reckoned from month to month, i.e. January to January), except in cases where evidence to justify a shelf life of more than sixty months is available to the satisfaction of the Central Licensing Authority.
If the medical device has a shelf life of less than ninety days, then at least 40% residual shelf-life should be available on the date of import. If the medical device has a shelf life between 90 days to 1 year, then at least 50% residual shelf-life should be available on the date of import. If the medical device has a shelf life of more than 1 year, then at least 60% residual shelf-life should be available on the date of import.
Exemption of labeling requirements for export
The labels on devices for export may be adopted to meet the laws of the land of the importing country, but following particulars must be provided 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: name of the device, name and address of the manufacturer, licence number, batch number, date of expiry, if any, and internationally recognized symbols in place of text, wherever required.
If the consignee requires the device without the name and address of manufacturer, the label on the package must bear a code number 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”. If the consignee requires the device without the code number, the label can bear a special code number, as requested by the consignee, and approved by the Central Licensing Authority.
Unique device identification of the medical device
From 1st January 2022, all the medical devices which are manufactured or imported must bear unique device identification which contains device identifier and production identifier. Device identifier means a global trade item number, which usually contains 14 digits, used by companies to uniquely identify its trade items. Production identifier means a batch number, software version, manufacturing, and or expiration date.
Labeling medical device or a new IVD for Test or Analysis
Such devices shall be kept in containers bearing labels, indicating the name of the product or code number, batch or lot number, serial number wherever applicable, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.
Custom Made Device
For devices which are specifically made in accordance with the prescription of qualified medical practitioner which is intended for the sole use of a particular patient and the label should contains the words ‘custom made device’