Medical device labeling requirements in Russia

1. Medical Device
Labeling in
Russia
Alexey Stepanov
The Pharmaceutical and Medical Device Labeling
Summit 2015
Berlin
27 October 2015

2. •Federal Law #412FZ “On
Consumer Rights Protection
•”Rules on approval
of sales of certain goods #55
dated 1998
Medical Device Labeling in Russia
main laws and regulations
Registration Customs
clearance
Advertizing,
sales and
distribution
Control in
clinics
•MD registration rules,
Resolution # 1416.
Common Sanitary, Epidemiological, and Hygienic Requirements to Goods subject to
Sanitary and Epidemiological Supervision (Monitoring) as approved by the Commission
of the Customs Union in its Decision No.299 dated May 28, 2010.
Official Clarification Letters from Roszdravnadzor, including
the letter # 293-22/34 “On marking of medical devices” dated
24.02.2004
Federal law “on advertizing”
#38FZ, article 7
Government Resolution No. 1037 of Aug. 15, 1997, "On Measures to Ensure the
Presence of Information in Russian on Nonfood Products to be Imported in the Russian
Federation”
Product –specific national (GOST) standards

3. Risks overview
of not translating labeling and IFU into Russian
Registration Customs
clearance
Advertizing,
sales and
distribution
Control in
clinics
•Original (non translated) labeling is allowed
for testing and registration.
•Original labeling should be submitted in the
registration file.
•Original IFU is a part of registration file (can
be translated locally).
•Once MD is approved, Roszdravnadzor
recommends submitting immediately Russian
labeling as notification procedure (see clause
55 of registration rules 1416).
•Labeling can be controlled by customs
officials in limited cases (damage of transport
container, sanitary reasons, suspect of non-
complience with transport documents etc…)
•Lack of translation or discrepancies with
registration can lead to seize of products or to
additional VAT load (18% instead of 0%)
•Russian language labeling is mandatory for tenders.
•For OTC products lack of Russian labeling can be considered
as consumer rights violations.
•Lack of information on number and date of registration could
be a reason to consider a medical device as non-registered.
•Lack of appropriately translated labeling increase the risk of
misuse of the device and lead to potential injury or even death.
Fig: Statistics on non-registered MD revealed by
Roszdravnadzor in Russia (source :Vestnik Roszdravnadzora #5 2014)

4. Risks overview
of not translating labeling and IFU into Russian
“Federal service on surveillance in healthcare informs […] about
reveal non-registered medical devices…”
“Medical device […] manufactured by […], reason – lack of
information on Russian language”.
“Federal service on surveillance in healthcare suggests […] to take
measures to prevent circulation of these non-registered
medical devices in Russian Federation…”
Example: Roszdravnadzor`s warning letter,
March 2014:
Roszdravnadzor: “Discrepancy in
marking of MD… including lack of data
about registration on the package is one
of the most common revealed violations”
http://www.roszdravnadzor.ru/medproducts/control/documents/b1260
“

5. • Placement of over-label, containing essentially
required data is the most common and wide-spread
method of marking of medical devices and comply
with labeling language requirements for foreign
manufacturers.
• A medical device can be marked either by placing all
the respective information over device itself or by
marking (placing the data) over the individual
package. Every “sales unit” should be labelled.
• There is no requirements on place, size, fonts etc for
label. Information shall be easy-read by the end-user,
made in water-proof ink, etc.
• To comply with all requirements over-label should be
placed before importation/customs clearance.
Over-labelling

6. General “minimal” requirements
Exact name of a medical device as approved in
the Russian registration certificate. No need to
transcribe the brand name.
Number and date of Russian registration certificate,
RST symbol
Name and address of the manufacturer
(in original language) the country of origin (in
Russian)
Main product properties*
Provided names of MD and a manufacturer are fictional
*see
specific
national
standards
Precautions and any special
storage conditions : “Information
should be provided to ensure
proper precautions of all hazards
using the whole complex of
protective measures”*

7. ….
….
Some specific National Standards
www.standards.ru
Recommended by Russian expert
centers to check compliance with
national standards.
GOST R ISO
14708-1-2012 –
active
implantable
medical devices
GOST R 51088-
2013
IVD
GOST ISO
26997-2003–
Heart valves
GOST R MEK
60601-1-2-
2014 Electrical
medical
devices
Specific labeling requirements
GOST R ISO 15223-1-2010 -
Medical devices - Symbols to be
used with medical device labels,
labeling and information to be
supplied.
GOST R 50444 -92 Medical
instruments, apparatus and
equipment. General specifications.
GOST 19126-
2007 –
Medical
instruments
GOST R
ISO 7886-1-
2009
Syringes
GOST ISO 4630
Non-active
surgical
implants

8. How to deal with changes?
• Require to renew the
registration certificate
within 30 days.
( see clause 37 of Registrations Rules #1416)
-Change of the manufacturer's name.
-Change of the manufacturer's address.
-Change of the country of origin.
-Change of the designation of a medical
device/model/accessory.
• Require to notify
Roszdravnadzor before
implementation.
(see clause 55 of Registrations Rules #1416)
-Any other changes in the labeling design.
-Any changes in the IFU.

9. • Common regulations for medical device circulation in
Russia, Belarus, Kazakhstan, Armenia and
Kyrgyzstan.
• For October 2015: Agreement between member-
states signed, second-level regulations are available
only as drafts.
• New regulations introduce EAC mark requirement for
medical devices approved by new harmonized
process.
Harmonized Eurasian Medical Device regulations

10. •Russian requirements for labeling of medical devices are based on
multiple regulations, laws and standards.
•Over the last few years medical device labeling is the subject of
increasing control from Russian healthcare regulator.
•Two main specific requirements presenting regulatory risks are:
mandatory Russian language and compliance with data in the
registration certificate.
•Placement of over-label containing essentially required data in
Russian is the most common and wide-spread approach to comply
with regulatory requirements for foreign manufacturers.
Russian Medical Device Labeling in 30 seconds…

11. Thank you!
Please check my blog about medical device
regulations in Russia and CIS
www.MedicalDevicesInRussia.com
@MedDevRus
Alexey@MedicalDevicesInRussia.com