Extension provided to importers of medical device to comply with affixing requirements till 31st December, 2017
The Central Drugs Standard Control Organization (“CDSCO”) has issued an Office Memorandum on 4th May, 2017 thereby extending the time period provided toimporters to comply with the provision for affixing sticker on the imported medical devices.
By virtue of the Office memorandum, importers are granted time till 31st December, 2017 to affix stickers on imported medical devices indicating the date of manufacture and date of expiry of such devices as per Drugs and Cosmetics Rules.
Prior to this, the importers were provided time till 25th May, 2017.
Earlier, it was observed by Government that while under International labelling norms, the expiry date is given in the same month as that of the manufacturing month, this is not in accordance with labeling requirements under Drugs and Cosmetic Rules, 1945 (“Rules”). Therefore, a relaxation was given to importers wherein, they were allowed to affix the sticker indicating the manufacturing date and expiry date as per the provisions laid down under the Rules till 25th May, 2017.
In this regard, representations were received from firms requesting for extension of time period as it was difficult to accommodate the change in labels in the given six months’ time frame (effective from 25th November, 2016).
Having considered the representation, and in view of the fact that the current regulatory rules (i.e. Medical Devices Rules, 2017) will come into effect from 1stJanuary, 2018, the CDSCO has decided to extend the above time period provided to importers to comply with the provision for affixing stickers, from 25th May, 2017 to 31st December, 2017.