Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I'm looking for specific input on Russian labeling.. I'm aware of the requirement to provide labels in Russian language which is common in other countries as well and not a general issue - however I'm wondering if there are any official recommendations or requirements whether the manufacturer or the authorized representative/distributor must provide these labels.

More precisely, can the AR request the (foreign/non-Russian) manufacturer to produce the Russian language labels or is that up to individual agreements between the two?

I found so labels have to be placed before importation/customs, will it be the manufacturer's duty to provide the AR in advance of the shipment with the labels? 

Possibly, someone has experienced such or similar scenario, or knows the requirements,

Thanks!

This message was posted by a user wishing to remain anonymous

... according to our contracts with the distributor, they are to take over all the costs relating to labels that state their address and name (if such labels are required or wanted).

If IFU and product description are available in Russian language and the label uses ISO 15223 compliant symbols, there should not be additional requirements for Russian language labels, or should there?

We have been exporting medical devices to Russia for several years and did not have to provide Russian language labels (apart from Russian IFU and product description which are available with the packaging).

Original Message:
Sent: 31-Jan-2019 08:47
From: Anonymous Member
Subject: Russian labels (medical devices)

This message was posted by a user wishing to remain anonymous

I'm looking for specific input on Russian labeling.. I'm aware of the requirement to provide labels in Russian language which is common in other countries as well and not a general issue - however I'm wondering if there are any official recommendations or requirements whether the manufacturer or the authorized representative/distributor must provide these labels.

More precisely, can the AR request the (foreign/non-Russian) manufacturer to produce the Russian language labels or is that up to individual agreements between the two?

I found so labels have to be placed before importation/customs, will it be the manufacturer's duty to provide the AR in advance of the shipment with the labels?

Possibly, someone has experienced such or similar scenario, or knows the requirements,

Thanks!

Hi,



------------------------------
Julia Ershova
Moscow
------------------------------

Original Message:
Sent: 12-Feb-2019 06:06
From: Anonymous Member
Subject: Russian labels (medical devices)

This message was posted by a user wishing to remain anonymous

... according to our contracts with the distributor, they are to take over all the costs relating to labels that state their address and name (if such labels are required or wanted).

If IFU and product description are available in Russian language and the label uses ISO 15223 compliant symbols, there should not be additional requirements for Russian language labels, or should there?

We have been exporting medical devices to Russia for several years and did not have to provide Russian language labels (apart from Russian IFU and product description which are available with the packaging).

Original Message:
Sent: 31-Jan-2019 08:47
From: Anonymous Member
Subject: Russian labels (medical devices)

This message was posted by a user wishing to remain anonymous

I'm looking for specific input on Russian labeling.. I'm aware of the requirement to provide labels in Russian language which is common in other countries as well and not a general issue - however I'm wondering if there are any official recommendations or requirements whether the manufacturer or the authorized representative/distributor must provide these labels.

More precisely, can the AR request the (foreign/non-Russian) manufacturer to produce the Russian language labels or is that up to individual agreements between the two?

I found so labels have to be placed before importation/customs, will it be the manufacturer's duty to provide the AR in advance of the shipment with the labels?

Possibly, someone has experienced such or similar scenario, or knows the requirements,

Thanks!

This message was posted by a user wishing to remain anonymous

Thank you, Julia,
especially for the specific reference!
In our case, Russian language labels (incl. name and number according to registration dossier, description and address of manufacturer and authorized representative in Russian) will now be applied to the products (with ISO 15223 compliant symblos and Russian description as well as Russian IFU in/on the box) by the authorized representative and distributor (in our case a different legal entity from the manufacturer) after import into the Russian Federation, but before sale and it has been confirmed to us that this fulfills the requirements.

btw, does it mean that the EEU documents have fully superseeded the Russian regulations, including customs regulations? I.e for customs, the respective regulation would be the Decision of the Commission of Customs Union #299 dated 28.05.2010.



Original Message:
Sent: 08-Mar-2019 01:18
From: Julia Ershova
Subject: Russian labels (medical devices)

Hi,

According to the requirements to MDs labeling established for Russian market (see Decision of Eurasian Economic Union #27 "On approval of general requirements to safety and efficacy of medical devices, requirements to their labeling and maintenance documentation" dd. Feb 12th 2016), each medical device should be accompanied by the mandatory information​ (regarding its manufacturer, country of origin, technical features, etc.) in Russian language. Such information should appear on the device label and its leaflet.

Considering the above it is up to device distributor and/or manufacturer (if these are two different legal entities) to decide at which stage of production or supply chain the product will be equipped with Russian label. 

------------------------------
Julia Ershova
Moscow

Original Message:
Sent: 12-Feb-2019 06:06
From: Anonymous Member
Subject: Russian labels (medical devices)

This message was posted by a user wishing to remain anonymous

... according to our contracts with the distributor, they are to take over all the costs relating to labels that state their address and name (if such labels are required or wanted).

If IFU and product description are available in Russian language and the label uses ISO 15223 compliant symbols, there should not be additional requirements for Russian language labels, or should there?

We have been exporting medical devices to Russia for several years and did not have to provide Russian language labels (apart from Russian IFU and product description which are available with the packaging).

Original Message:
Sent: 31-Jan-2019 08:47
From: Anonymous Member
Subject: Russian labels (medical devices)

This message was posted by a user wishing to remain anonymous

I'm looking for specific input on Russian labeling.. I'm aware of the requirement to provide labels in Russian language which is common in other countries as well and not a general issue - however I'm wondering if there are any official recommendations or requirements whether the manufacturer or the authorized representative/distributor must provide these labels.

More precisely, can the AR request the (foreign/non-Russian) manufacturer to produce the Russian language labels or is that up to individual agreements between the two?

I found so labels have to be placed before importation/customs, will it be the manufacturer's duty to provide the AR in advance of the shipment with the labels?

Possibly, someone has experienced such or similar scenario, or knows the requirements,

Thanks!