- The following particulars shall 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, namely,-(a)name of the medical device;(b)the details necessary for the user to identify the device and its use;(c)the name of manufacturer and address of manufacturing premises where the device has been manufactured;(d)the correct statement about the net quantity in terms of weight, measure, volume, number of units, as the case may be, and the number of the devices contained in the package expressed in metric system;(e)the month and year of manufacture and expiry (alternately the label shall bear the shelf life of the product):Provided that in case of sterile devices, the date of sterilization may be given as date of manufacture of the device:Provided further that where 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.Explanation. - For the purposes of this clause, 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";(f)to provide, wherever required, an indication that the device contains medicinal or biological substance;(g)to provide, a distinctive batch number or lot number preceded by the word "Lot No." or "Lot" or "Batch No." or "B. No.";(h)to indicate, wherever required, any special storage or handling conditions applicable to the device;(i)to indicate, if the device is supplied as a sterile product, its sterile state and the sterilization method;(j)to give, if considered relevant, warnings or precautions to draw the attention of the user of medical device;(k)to label the device appropriately, if the device is intended for single use;(l)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;(m)to provide, except for imported devices, the manufacturing licence number by preceding the words "Manufacturing Licence Number" or "Mfg. Lic. No." or "M. L";(n)to provide on the label, in case of imported devices, by way of stickering, where such details are not already printed, the import licence number, name and address of the importer, address of the actual manufacturing premises and the date of manufacture:Provided that the label may bear symbols recognized by the Bureau of Indian Standards or International Organization for Standardization (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;(o)in case of small sized medical devices on which information cannot be printed legibly, shall include the information necessary for product identification and safety such as information covered by clauses (a), (b), (c), (d), (e), (g), (k), and (m) shall be included.
