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Indian Labeling Requirements for Imported Medical Devices

C

chloep17

#1
Can anyone advise whether it is necessary to include 'Manufactured on' dates on the labelling of medical devices being imported into India?

I have tried to find the labelling requirements for India but cannot find a specific document.

Any help would be greatly appreciated.

Many thanks.
 
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G

Gert Sorensen

#3
I tried to have a look at this, and it seems to me that you do not need to state manufactured on, but you need to state date of expiry or
use before date.
:bigwave:
 

Ajit Basrur

Staff member
Admin
#4
Can anyone advise whether it is necessary to include 'Manufactured on' dates on the labelling of medical devices being imported into India?

I have tried to find the labelling requirements for India but cannot find a specific document.

Any help would be greatly appreciated.

Many thanks.
The Labeling requirements are defined in Rule 96 of the Drugs & Cosmetics Act (D & C). Typically, the Rule 96 is applicable for Drugs and I am not sure of its scope to Medical Devices.

I am attaching a draft guidance document from CDSCO, the regulatory body in India, that has this mention of Rule 96 - http://cdsco.nic.in/Medical_div/RC final doc - colour.doc

.
 

Attachments

V

vitols

#6
The Medical device division of CDSCO declares the listed medical devices there as drugs and the Drugs and cosmetics rules shall be followed.
Is your medical device being imported covered under the medical device division as a medical device ?
If so, then the D & C act / rules applies.

... And if no? which requirement must I follow?

that is, in case my Medical Device (to be imported in India) isn't a notified Medical Device regulated by The Drug & Cosmetic Act & Rules?

:thanx:
 

bio_subbu

Super Moderator
#7
Can anyone advise whether it is necessary to include 'Manufactured on' dates on the labelling of medical devices being imported into India?

I have tried to find the labelling requirements for India but cannot find a specific document.

Any help would be greatly appreciated.

Many thanks.
The details on India medical devices labeling requirements are mentioned in CDSCO's Schedule M-III (?ANNEX XIII of Schedule M-III (Requirements For The Manufacture, Import And Sale Of Medical Devices)?). As regards to imported devices, information may be required to contain in addition, the name and address of either the importer established within the importing country/region or of an authorized representative of the manufacturer established within the importing country/region. (Refer page 77 of 83, Content of Labelling a))
 

Attachments

M

medgar

#8
Hi All

There is 'chatter' that Indian regulators will begin requiring importers to affix labelling information to their products before shipping to the country by 28-Sep-2014.

Currently, the system allow for ?India-specific? labelling to be attached to imported devices at their Indian ports of entry by distributors.

Can anyone verify this?

Does anyone know what legislation, circular has been published by CDSCO or the govt that introduces this change?

Cheers
 

bio_subbu

Super Moderator
#10
Hi All

There is 'chatter' that Indian regulators will begin requiring importers to affix labelling information to their products before shipping to the country by 28-Sep-2014.

Currently, the system allow for ?India-specific? labelling to be attached to imported devices at their Indian ports of entry by distributors.

Can anyone verify this?

Does anyone know what legislation, circular has been published by CDSCO or the govt that introduces this change?

Cheers
Hi

You are right, India's medical device regulator CDSCO (Central Drugs Standard Control Organization) will begin requiring importers to affix labeling information to their products before shipping to the country in September 2014. A copy of circular can be downloaded from below CDSCO link.

http://www.cdsco.nic.in/writereaddata/OM 28.3.2014.pdf
 

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