Medical device manufacturers must follow labelling requirements and appropriate labelling must be done on all Medical Devices before placing them in Indian Market. Rule 109A of Medical Device Rules, 2017 gives instructions for labelling of Medical Devices in India.
The following details must be printed in indelible ink on the label, on the shelf pack of the medical device or on the outer cover of the medical device and on every outer covering in which the medical device is packed:
1. name of the medical device;
2. the details of the device and its use;
3. the name and address of manufacturer
4. net quantity in terms of weight, measure, volume, number of units, and the number of the devices contained in the package expressed in metric system;
5. the month and year of manufacture and expiry (alternately the label shall bear the shelf life of the product):
- In case of sterile devices, the date of sterilization can be given as date of manufacture of the device.
- If the device is made up of stable materials such as stainless steel or titanium, and supplied non-sterile or in case of medical equipment or instruments or apparatus, the date of expiry may not be necessary.
- The date of expiry shall be in terms of the month and the year and it shall mean that the medical device is recommended till the last day of the month and the date of expiry shall be preceded by the words “Expiry date” or “Shelf Life”;
6. an indication that the device contains medicinal or biological substance, if applicable;
7. a distinctive batch number or lot number preceded by the word “Lot No.” or “Lot” or “Batch No.” or “B. No.”;
8. any special storage or handling conditions applicable to the device;
9. if the device is supplied as a sterile product, its sterile state and the sterilisation method;
10. warnings or precautions to draw the attention of the user of medical device;
11. if the device is intended for single use;
12. to overprint on the label of the device, the words “Physician’s Sample—Not to be sold”, if a medical device is intended for distribution to the medical professional as a free sample;
13. the manufacturing licence number by preceding the words “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M. L” for devices Manufactured in India and “Import License number” or “Imp. Lic. No.” or “I. L” for devices Imported into India.
14. the import licence number, name and address of the importer, address of the actual manufacturing premises and the date of manufacture, in case of imported devices, by way of stickering, where such details are not already printed.
The label may bear symbols recognised by the Bureau of Indian Standards (BIS) or International Organisation for Standardisation (ISO) in lieu of the text and the device safety is not compromised by a lack of understanding on the part of the user, in case the meaning of the symbol is not obvious to the device user;
The Instructions for Use (either paper or electronic) need to be accompanied along with the label of the Medical Device, as applicable.
