GOST-R services presentation [ PDF 3947 kB ] - TÜV SÜD Russia

TÜV SÜD Russia 10/01/2013 Slide 1 

TÜV SÜD Russia 

Ensure your products comply with safety 

regulations of Russia and Customs Union

Russia – attractive market 

Over the past years Russian Federation (RF) has 

made significant progress in its market reforms. 

The country‘s economic growth for this period is a 

consistent and sound economic strategy focused on 

modernizing the country‘s financial system and 

developing market infrastructure. Russian GDP 

growth rates for 2011, 2012 and 2013 are 4.3%, 

4.0% and 3.9%, respectively. 

Russia is currently the fastest growing export 

market and the third largest after Europe and North 

America. Opportunities are increasing, in part due to 

the modernisation of the economy and the 

development of infrastructure. However there are 

requirements that must be met in order to supply 

goods and services to Russia. 

This presentation is intended to provide a practical 

approach to what you need to know about the 

certification system in Russia and the territory of the 

Customs Union (Russia, Belarus and Kazakhstan). 


10/01/2013 10/01/2013 Slide 2

Main Trade Partners of Russia 


Country 

China 

Germany 

Italy 

France 

Turkey 

Japan 

USA 

Korea 

UK 

* http://www.tpprf.ru 

10/01/2013 Slide 3 

Turnover in year 

2011, US dollars* 

83,5 billion 

71,8 billion 

46,0 billion 

28,1 billion 

31,8 billion 

29,7 billion 

31,2 billion 

25,0 billion 

10,2 billion

1.Technical Regulations replacing GOST-R 

Russia offers some unique advantages over many established and developing markets. Many foreign businesses 

wishing to work on Russian market must first tackle the problem of National certification. 

Russia has its own certification system for controlling the import and sale of goods and equipment – GOST-R. 

GOST means «national standard» and R stands for «Russia». Because there is no treaty between Russia and the 

European Union for the mutual recognition of certificates, experts must review the certificates to verify that they 

conform to Russian standards when machines, packaging and products for the cosmetics, food, chemicals and 

other industries enter the country. 

One precondition for Russia’s accession to the World Trade Organization was that Russia had to reform the 

Technical Regulations in order to harmonize the national standardization system with the European system and to 

raise it to a level that is consistent with the requirements of today’s business environment. 

In year 2011 more than 30 new technical regulations were approved GOST-TR replacing previous GOST-R. 


RST mark (old) STR mark (new) 

A GOST-TR Certificate is an official document issued by a Certification Body, confirming compliance with the relevant Technical Regulation. 

10/01/2013 Slide 4

2.Welcome to NEW economic space – Customs Union 

On 1 st of July 2010 the Customs Union (CU) between 

the Russian Federation, Belarus and Kazakhstan 

came into force. 

The more clear borders are set to expand markets for 

businesses within the zone and make trading more 

competitive. Foreign companies already operating in 

one of the three markets could also benefit from easier 

access to other states within the union. 

Uniform standards were developed – Technical 

Regulations of Customs Union, which are valid on the 

territories of 3 countries (Russia, Belarus and 

Kazakhstan). 

Other countries that have expressed an interest in 

joining the union include Kyrgyzstan, Tajikistan and 

Ukraine. 


10/01/2013 

Slide 5

3.Federal Agency – Rosaccreditation 

At this moment in Russia exist 1638 official Certification Bodies and more than 8000 laboratories and intermediary 

companies.* 

On 24 January of 2011, according to the law № 86 «About uniform national accreditation system» was established 

Federal Agency of Accreditation – Rosaccreditation. This is an authorized federal executive body, responsible 

for formation of unified national system of accreditation of Russian Federation.** 

In the field of accreditation Rosaccreditation acts like legal successor of Rosselkhoznadzor, Ministry of Regional 

Development, Ministry of Communications, Rostehregulirovanie, Rospotrebnadzor, and even Federal Agency 

of Railway Transport. 

* http://www.gost.ru/wps/portal/pages.en.SertificationOrgans 

** http://www.fsa.gov.ru 

TÜV SÜD Russia 10/01/2013 Slide 6

Some Russian Technical Regulations in force 

12/04/2006 Special technical regulation on requirements for emissions of harmful (polluting) 

substances by vehicles in circulation on the territory of RF 

05/09/2008 Technical regulation on requirements for automotive and aviation gasoline, 

diesel and marine fuel, jet fuel and heating oil 

17/12/2008 Technical regulation on milk and milk products 

28/12/2008 Technical regulation on oil and fat products 

28/04/2009 Technical regulation on juice products from fruits and vegetables 

01/05/2009 Technical regulation on fire safety requirements 

26/12/2009 Technical regulation on tobacco products 

01/07/2010 Technical regulation on the security of buildings and structures 

23/09/2010 Technical regulation on the safety of wheeled vehicles 

25/09/2010 Technical regulation on safety of machinery and equipment 

14/10/2010 Technical regulation on safety of lifts 

31/12/2010 Technical regulation on approval of technical rules on security requirements for blood, its products, 

substituting the solutions and technical means used in transfusion-infusion therapy, entered into force on 

01/01/2011 Technical regulation on the safety of gas appliances 


Reformation in progress… 

10/01/2013 Slide 7

Modernization of conformity assessment in Customs Union 

Law on certification of products and services 

from 10 th of June 1993, № 5151-1 

(rules of certification) is not valid any more 

Law onTechnical Regulations from 27 th December 2002 №184-ФЗ 

(Technical regulations) 


GOST-R 

RST marking 

TR 

CTR marking 

Customs Union (CU) resolution № 319 

from 18 th of June 2010, 

(list of products under mandatory 

assessment of conformity of Customs Union ) 

CU 

Marking according to national law 

Agreement on united principles and rules of Technical regulation in Belarus, 

Kazakhstan and Russia 

TR CU 

EAC marking (Eurasian conformity) 

10/01/2013 Slide 8

Development of Customs Union Technical Regulations 

15/02/2012 On safety of fireworks 

01/06/2012 On safety of personal protective equipment 

01/07/2012 

31/12/2012 


Come into force: 

On safety of toys 

On safety of products intended for children and adolescents 

On safety of perfumes and cosmetics 

On safety of packages 

On safety of production of consumer goods ( light industry products) 

On requirements for automobile and aviation gasoline, diesel and marine fuels, jet fuels 

and heating oils 

10/01/2013 Slide 9

Development of Customs Union Technical Regulations 


Coming into force: 

15/02/2013 On safety of machinery and equipment 

On safety of equipment for operation in explosive atmospheres 

On electro magnetic compatibility 

On safety of lifts 

On safety of low voltage equipment 

On safety of devices, operating on gas fuels 

02/08/2014 On safety of railway rolling stock 

On safety of high-speed railway transport 

On safety of railway infrastructure 

15/02/2015 On safety of motor roads 

Development schedule: 

47 Technical Regulations of Customs Union 

in 2011 were included in development schedule of the first priority: 

- Russian Federation - 26 - Belarus – 8 - Kazakhstan – 13 

10/01/2013 Slide 10

Product geography 

Fire safety Ex-proof Metrology 

Project 

GOST-R à GOST- TR à Customs Union-TR 

Hygiene 

Technical documentation 

Telecom 

approval 

National Industry Safety Expertise – RosTekhNadzor (RTN) 

Equipment 

TÜV SÜD Russia 10/01/2013 Slide 11 

Facility 

Medical 

Registration

Our services 


Service portfolio of TÜV SÜD 

GOST-R/TR certificate of conformity 

(for products produced or imported to Russia) 

CU-TR certificate of conformity 

(Customs Union Technical Regulations) 

Certificate of State Registration for Customs Union 

(conformity to Hygienic norms) 

Registration of Medical Devices 

(for Medical Equipment) 

Fire Safety Certificate 

(for Fire safety) 

GOST-R Ex-Proof Certificate 

(for Explosion proof) 

Pattern Approval Certificate of measuring instruments 

(Metrology) 

Industrial safety expertise 

(experts appraisal for Industrial Safety) 

Permit for use of ROSTEKHNADZOR 

(confirms correspondence to Industrial Safety) 

Certificate of communication devices 

(Telecom) 

Technical documentation 

(according to national standards) 

10/01/2013 Slide 12

GOST-R / TR / CU-TR Certificate | State Registration for CU-TR 


GOST-R / TR / CU-TR Certificate 

Certificate for products manufactured in Russia or 

imported from overseas to confirm compliance with 

National standards. This certificate can be issued either 

for a batch of goods or on a series-production. GOST-R 

Certificates may be 

mandatory or voluntary. 

The list of products, 

which are subject to 

mandatory certification 

is given in decrees of 

the Federal Agency on 

Technical Regulating 

and Metrology. 

10/01/2013 Slide 13 

Certificate of State Registration 

for Customs Union 

Since the Customs Union came into force on 1 July 

2010, there is one common Certificate for all three 

countries of Russia, Kazakhstan and Belarus to confirm 

compliance with the sanitary-epidemiological rules and 

specifications of products, 

substances, dietary 

supplements 

(except medicines).

Registration of medical devices | Telecom approval 


Registration of medical devices 

This certificate confirms the fact of registration of 

medical equipment. Medical devices cannot be used for 

healthcare purposes without the registration in the 

Ministry of Healthcare and Social Development of 

Russian Federation. 

10/01/2013 Slide 14 

Certificate for communication devices 

The certificate shows the fact of assessment of 

conformity of equipment used in communication field: 

mobile phones, transmitters, devices with Wi-fi, 

Bluetooth, GPS etc.

Fire Safety Certificate | Explosion Proof Certificate 


Fire Safety Certificate 

Document, conforming the compliance of products or 

services with «Technical Regulations on Fire Safety 

Requirements» 

Fire Safety Certificate can be mandatory or voluntary. 

The list of 

products, which are 

obligatory for fire 

certification can be 

found in RF Decree 

(dated 01.05.2009). 

10/01/2013 Slide 15 

Explosion Proof Certificate 

The certificate applied to devices or equipment, which is 

used in hazardous production facilities. 

The list of these products- subject for certification is 

elaborated and 

approved according to 

the procedure, 

established 

by the Government 

of Russian Federation 

(Decree “On 

authorization of 

Certification Rules for 

explosion-proof 

equipment intended for 

highly explosive 

medium” dated from 

19.03.2003, № 28/10).

Permit for Use of ROSTEKHNADZOR | Industrial Safety Expertise 

Permit for Use of ROSTEKHNADZOR 

(RTN – Industrial Safety) 

Document that confirms compliance of technical 

devices with the requirements of industrial safety and 

allows the appliance of such equipment in hazardous 

production facilities supervised by 

ROSTEKHNADZOR – Russian Federal 

Service for Ecological, 

Technical and Atomic 

Supervision. 


10/01/2013 Slide 16 

Industrial Safety Expertise 

Compliance evaluation of the Object of Expertise with 

the requirements of industrial safety. 

Object of Expertise – can be project documentation, 

technical equipment, 

buildings, constructions 

or other documentation 

regarded to exploitation 

of hazardous production 

facility.

Technical Documentation | Metrology Certificate 


Technical Documentation 

Elaboration of documents, necessary for certification in 

Russia in accordance to national regulations and rules. 

Our specialists in Technical Documentation are ready 

to support you 

by developing of 

all necessary technical 

documentation: 

Passport of technical 

equipment, Operating 

manual in Russian, 

Acceptance test 

protocols and more. 

10/01/2013 Slide 17 

Pattern Approval Certificate of 

measuring instruments 

Document issued by the Federal Agency on Technical 

Regulating and Metrology confirming that the present 

type of measuring tools correspond to special norms 

and regulations, established by Russian Federation. 

This certificate also 

confirms that the present 

measuring instrument 

has successfully 

passed technical and 

metrological tests and is 

permitted for appliance 

in Russia.

Customs Union Light industry safety Technical Regulation 

Customs Union adopted the Technical Regulation on1st July 2012. There are 2 forms of conformity assessment -Declaration 

and Certificate. 

Textile materials 


Products – subjects to TR 

Clothes, garments and knitted goods 

Coatings and carpet products 

Leather goods, textiles and haberdashery 

Felt and non-woven materials 

Footwear 

Furs and fur products 

Leather and leather products 

Artificial leather 

10/01/2013 Slide 18

Light industry products 

Group of products for TR Declaration: Group of products for TR Certificate: 

-clothes and products of the 2nd and 3rd layers; 

-stocking of the 2nd layer; 

-knitted clothes; 

- fabrics and linen materials, huckaback; 

- leather and fur clothes and products; 

- head wears; 

- footwear, except felt; 

- carpets and products of a machine production. 

TÜV SÜD Russia 10 January 2013 

-underwear, foundation garments, swim wear and its 

analogues ; 

- stocking of the 1st layer; 

- bed linen. 

Products which are not under TR: 

- souvenir samples; 

- textile wrapping materials; 

- tubular woven; 

- art products, wigs; 

- textile products for medical use; 

- materials being in use; 

- sport equipment.

Classification of layers 

1 st layer (the products having direct contact with human skin): 

1 st layer (the products having direct contact with human skin): 

- underwear and bedding; 

- foundation garments and swimwear; 

- light (summer) head wear; 

- stockings; 

- handkerchiefs; 

- scarf –neckcloth. 

2 nd layer (the products having indirect contact with human skin): 

2 nd layer (the products having indirect contact with human skin): 

- 

- dresses, blouses, shirts; 

- trousers, skirts, unlined suits; 

- sweaters, pullovers, woolies; 

- head wear; 

- gloves, mittens; 

- warm stockings ( winter assortment). 

3d layer (the products for cover up the 2 nd layer): 

3d layer (the products for cover up the 2 nd layer) 

coats, duffle coats, jackets, raincoats, lining suits etc. 


10/01/2013 Slide 20

Basic principles of clothes classification 

- cover up (upper wear) clothing: jackets, woolies, 

knitted vests, suits, blouses, skirts, 

dresses, pinafores, shorts, dressing-gowns, trousers, 

jumpsuits, leggings, sport wear; 

- stockings: spats, socks, footlets; 

- gloves: mittens and analogues; 

- scarf –neckcloth: head scarf, kerchiefs; 

- outerwear: coats, duffle coats, jackets, raincoats, 

sport suits, jumpsuits; 

- body shirts; 

- suits: jackets, skirts, vests, shorts, trousers; 

- dresses: dress, skirts, blouses, dickeys. 


- home clothing: dressing-gowns, suits; 

- underwear: body linen, bed linen, kitchen linen, 

swimming, handkerchiefs; 

- garments: bra, basques; 

- bed linen: blankets, pillows; 

10/01/2013 Slide 21 

- head wear: caps, hats, panamas, berets, skull-caps; 

- leather goods: bags, suitcases, cases, knapsacks, 

folders, gloves, belts; 

- leather clothes.

Labelling 

Marking has to be put: 

Marking has to be put: 

- on the product, 

- on a product label or commodity label, 

- on a package or package inserts. 

Label must contain the following information: 

- Product name 

- Original country 

- Manufacture name or representative 

- Legal address 

- Product dimension 

- Raw materials 

- Trade mark 

- EAC mark 

- Manufacture warranties (possible) 

- Production date 


10/01/2013 Slide 22

Labelling 

For soft clothes and goods: 

- kind and percentage of chemical in upper wear and 

underlay. Declination of fact ratio mustn’t exceed 5%. 

- model 

- care symbols on a label 

- maintenance instruction (possible) 


For footwear: 

- model or article 

- kind of material for the top and bottom 


For leather goods : 

- kind of top material 

- model 


do: 

- label must be in Russian 

- original country and legal address of the manufacturer may be written with Latin letters 

don’t: 

- label «eco-friendly», «orthopedic» without a related confirmation 

10/01/2013 Slide 23

Testing 

Physical, Mechanical and flammability properties 

of Textiles/Garment and Footwear 

Color fastness testing 

Dimensional stability & appearance 

Fibre analysis 

Tensile, tear & seam strength 

Special property testing like smoothness appearance 

Pilling, abrasion resistance 

Wash care label verification 


10/01/2013 Slide 24

Toy Product Market in Russia 

Some facts⃰ 

Russian market of toys is one of the most 

perspective in Europe and rapidly developing in 

the world - about 25-30% a year. 

The fastest growing segment - products for babies 

caused by new governmental social program in 

demographic sector. 

Toy market in Russia is ~ $ 2.4 billion, while the 

whole world market is estimated $ 80 billion. 

Currently 60% of the toys in the world is produced 

in Asian countries, especially in China. 

In Russia 88-90% of toys are imported. 

⃰ Industry Association of children goods 


10/01/2013 Slide 25

Regulations for Toy Market in Russia 

1992/01/01 

2005/12/19 

2010/01/01 

2010/05/28 

2010/06/28 

2012/07/01 - NEW 

2012/07/01 - NEW 


GOST 25779-90 Toys. General safety requirements and methods of control 

MUK 4.1/4.3.2038-05 - 4.1/4.3 Methods of control. Chemical and physical factors. Sanitaryepidemiologic 

assessment of toys 

GOST-R ISO 8124-2-2008 Toys. General safety requirements. Part 2. Flammability 

Sanitary-epidemiological and hygienic requirements to the goods (approved by CU №299 

Chapter II, Section 2. Requirement security to the goods of children assortment) 

SanPiN 2.4.7/1.1.2651-10 «Hygienic requirements to clothes for children, teenagers and 

adults, goods of children assortment and materials coming in contact with skin» 

Technical Regulation «On safety of products intended for children and teenagers» 

(TR CU 007/2011) 

Technical Regulation «On toy safety» (TR CU 008/2011) 

10/01/2013 Slide 26

Russian Rules for Toy Import 

All toys in Russian Federation : 

ü Should correspond to safety requirements of mandatory Technical Regulations 

ü Are divided into types (dolls, puzzles, for designing, soft toys, educational toys, mechanical toys, sensor toys etc.) 

ü Certification of toys in Russia requires laboratory tests on: 

- material of the toy 

- functionality and safety 

- belonging to a certain age group 

ü Are subject of mandatory assessment of compliance: 

norms* 

hygienic 

microbiologic 

toxicological 

organoleptic 

properties** 

physic 

mechanic 

flammable 

electrical ( < 24W) 

*GOSТ 25779-90 MUK 4.1/4.3.2038-05 - 4.1/4.3 (from 19 December 2005) 

**GOST-R 53906-2010 GOST–R ISO 8124-2-2008 for electrical toys GOST –R 51317.3.2 -2006, GOST –R 51317.3.3 -2006 

TÜV SÜD Russia Slide 27 

10/01/2013

NOT TOYS according to new CU-TR* 

Folklore and decorative dolls 

Puzzles containing more than 500 details 

Products with heating elements 

Vehicles / toy cars with steam engines / bicycles 

Games and toys working at rated voltage > 24 W 

Exact copies of firearms / pneumatic weapon / 

catapults and devices for throwing 

Means of protection (for swimming, sunglasses, 

bicycle helmets, helmets for skateboard) 

Flying toys which are started by the child by 

means of a rubber cord 

Sanitary & hygienic products from latex, rubber 

and silicone 

⃰http://www.tsouz.ru/KTS/KTS31/Documents/P_798_3.pdf 


10/01/2013 Slide 28

Testing for Toys 

Requirements for chemical substances in toys 

Smell and water extract 3-5 score 

Migration of chemical substances 

into the water: benzene < 0, 01 mg/dm 3 

Formaldehyde < 0, 1 mg/dm3 

Migration of chemical substances 

in the air: Phenol < 0, 05 mg/dm3 

Styrene < 0, 002 mg/dm3 

Toluene < 0, 6 mg/m3 

Ethyl benzene < 0, 02 mg/m3 

Index of overall toxicity < 20% 


Organoleptic characteristics: 

Smell intensiveness of toys (score) * 

0 - without any smell 

1 - very slight (only experienced tasters can reveal it) 

2 - slight smell 

3 - remarkable smell which can provoke negative reaction 

4 - distinct strong smell 

5 - very strong smell 

*MUK 4.1/4.3.2038-05. 

10/01/2013 

Slide 29

On safety of perfume and cosmetic products 

According to the Technical Regulation of the Customs Union "On safety of perfumes and cosmetic products" which 

came into force on July 1, 2012. (TP TC 009/2011,ratified by the Decision of CU dated 23 September 2011 N 799) 

Goods refer to perfume or cosmetic products if they are intended for: 

external use; not for swallowing, inhaling or implanting in the human body; 

skin, hair, teeth, nails, oral cavity care (soap, deodorants etc.); 

cleaning or changes in appearance of skin, hair, teeth, nails, oral cavity without violation 

of integrity, for pleasant flavor or right shape (for shaving, for color dye etc.) 

cosmetic oil; 

perfumes; 

lip, eyes, nails make-up products; 

powder; 

products for body care; 

shampoo; 


Declaration of Conformity is required for: 

10/01/2013 

hair spray, lotions; 

dentifrice; 

deodorants; 

aromatic bath salt; 

soap and detergents 

Slide 30


According to the Technical Regulation of the Customs Union "On safety of perfumes and cosmetic products" which 

came into force on July 1, 2012. (TP TC 009/2011,ratified by the Decision of CU dated 23 September 2011 N 799) 


Cosmetic products, means and products of oral hygiene – subjects to TR, requiring 

State Registration Certificate 

- Cosmetics for whitening (bleaching) of the skin; 

- Cosmetics for personal skin protection from harmful factors; 

- Cosmetics for artificial tanning; 

- Make-up for a tattoo 

- Intimate cosmetics; 

- Baby care cosmetics; 

- Perfumes and cosmetics for chemical coloring, bleaching and hair 

highlighting; 

- Perfumes and cosmetics for perming and hair straightening; 

- Perfumes and cosmetics made with use of nanomaterials; 

- Perfumes and cosmetics for hair removal; 

- Peeling; 

- Fluorine-containing oral hygiene products with fluoride- 0.15% (for liquid 

oral hygiene - 0.05%); 

- Products for teeth whitening containing hydrogen peroxide or other 

components that produce hydrogen peroxide, including carbamide peroxide 

and zinc peroxide with concentration of hydrogen peroxide 0.1% - 6.0% 

10/01/2013 Slide 31


1. Product line, ICN 

Documentation for State Registration and 

for Declaration of Confirmation: 

2. Previous certificates and test report (advisable) 

3. Samples of the product 

4. List of containing ingredients, organoleptic and physic-chemical indexes 

5. Package and label marking 

6. ISO or GMP certificate 

7. Document which confirms product properties declared in marking 


10/01/2013


Russian Rules for Import 

Perfumery and cosmetics are to be labeled with a unified mark of product 

circulation. The mark of conformity must be affixed to the packaging of the 

product. 

The substances prohibited and permitted for use in perfumery and 

cosmetics are listed in TR CU 009/2011. 

Compliance by perfumery and cosmetics is assessed in the format of a 

declaration with the participation of a testing laboratory centre. Goods 

should perform of physico - chemical, microbiological, toxicological and 

clinical tests. 

All information on the product, its packaging or attached leaflets must be 

fully translated into the Russian language. 

GOST R Declarations of conformity issued before this date can be used 

until their expiry date, but not later than the 1st July 2014. 


10/01/2013

The State Registration replaced Hygienic Certificates 


The State Registration Certificate 

ü The Certificate of state registration has replaced the Certificate 

of the state hygienic registration (Hygienic Certificates are not 

longer available since the 2010). 

ü Before it was necessary to get SEZ - sanitary-epidemiological 

conclusion. 

ü The Certificate of state registration does not have the expire 

date. 

ü Period for preparation of certificate – 2 months. 

10/01/2013 Slide 34

The State Registration Certificate 

Bottled drinking water, alcoholic production, 

soft drinks; 

Baby food, products for pregnant women, 

healthy food, special food for sportsmen, 

BAA; 

Products with GMO; 


List of goods - subjects to the State Registration⃰: 

Food with vegetative extracts, 

microorganisms and bacterial ferments; 

Cosmetics, personal hygiene products; 

Disinfection products and 

cleaning household goods; 

Chemical and petrochemical products for 

industrial use, domestic chemicals; 

Materials and devices intended for use in 

systems of drinking water supply; 

Products intended for contact with food, 

except tableware, food processing 

equipment. 

⃰ The list of goods subject to sanitary - epidemiological surveillance. Resolution №299 from 2010/05/28 

10/01/2013 Slide 35

The State Registration replaced Hygienic Certificates 

Application; 

Information on the product; 

Safety data sheet; 


List of documents needed for 

the State Registration: 

Information on the components (formulation); 

Scanned copy of the label; 

Existing certificates for the product and manufacturer’s 

ISO certificates; 

For specialized categories like GMO, BAA additional 

declarations will be needed. 

10/01/2013 Slide 36


Specifics of conformity assessment 

Step 1. Registration Certificate 

On Resolution №7-N, from 2012/06/15 issued by the 

Russian Ministry of Health, it is prohibited to purchase 

and use foreign-made medical equipment in Russia 

without it being registered with the Ministry of Health & 

Social Development. 

Medical equipment for prophylaxis, rehabilitation, 

diagnostics, medical research, treatment, etc. must 

run technical, safety, toxicology and clinical tests in 

Russia. They often last more than three months. 

Test results may suspend a decision on registration of 

a medical product; consider modification of 

registration documentation. 

Re-registration is needed if manufacturer’s or 

product’s name, application area or specifications 

have changed. 

Step 2. GOST-R 

Declaration of Conformity (if Registration Certificate 

has been obtained) 


10/01/2013 Slide 37


The Russian legislation on medical devices 

2006/10/30 "On the approval of Administrative 

Regulations of the Federal Service for 

Supervision of Health and Social 

Development for the fulfillment of state 

functions for the registration of medical 

devices“, came into force 2006/12/29 

2008/12/16 “On the methodical recommendations for 

preparing documents for registration of 

medical products" N 01И-809/08 

(Roszdravnadzor) 

2009/12/01 Resolution “On replacement certification by 

declaration of conformity for majority of 

medical devices”№ 982, came into force 

2010/02/15 

2011/11/21 Federal Law №323-FL “On healthcare of 

citizens in the RF” 

2012/06/15 Resolution №7-N of the Russian Ministry of 

Health “On import of medical equipment on 

the territory of the RF for registration purpose” 


10/01/2013 Slide 38

Assessment of Medical devices 

Documents required for registration of 

medical equipment 

Specifications for goods with technical parameters 

Protocols of works’ test reports (if available) 

Application instruction 

Sample 

A picture of the medical device / equipment. 

Classification according to the degree of 

potential risk of application 

Class 1 - Medical products with a low degree of risk 

(microscopes, medical scales, audio reaction testers etc.); 

Class 2a - Medical products with a medium degree of risk 

(audiometers, laboratory equipment, spirometers etc.); 

Class 2b - Medical products with a higher degree of risk 

(cardio-check analyzers, plethysmographs, defibrillators etc.); 

Class 3 - Medical products with a high degree of risk 

(implants, prostheses, lithotripters etc.) 


10/01/2013 Slide 39

Radiocom / Telecom CoC and DoC 

Certificate of Conformity (CoC) 


Since 2004 when a new Federal Law of Communications №126-FL came into force, 

there have been two main procedures for conformity assessment: 

10/01/2013 

Declaration of Conformity (DoC) 

Slide 40

Conformity assessment of Telecom devices 

List of equipment for mandatory 

certification 

Certification of Conformity is required* for : 

- communication devices performing functions of 

communication switching system, SDH system, 

control & monitoring system, devices with 

measuring functions; 

- line terminating equipment; 

- means of engineering or special network; 

- software used for operational – investigative 

service. 

⃰Government Regulation Act from 2009-06-25 , #532 


10/01/2013 

List of equipment for mandatory 

declaration 

Subjects for obligatory Telecom Declaration: 

- mobile phones with GSM, WCDMA, HSDPA, 

CDMA; 

- electronic devices with wireless technologies 

Bluetooth, Wi-Fi, WiMAX, LTE; 

- devices with GPS /GLONASS; 

- …and more 

Slide 41

For Russian Telecom Market 

Pre-requirement for 

Conformity Assessment 

It is necessary to provide the following 

information: 

- product name 

- HS code 

- technical specification (with indication 

of power voltage, transmit-receive 

frequencies, transmitted power ) 

- existence / absence of enciphering 

algorithm (including Bluetooth, Wi-Fi, 

WiMAX) 


10/01/2013 

Documentation for 

Telecom equipment 

- FSS Manufacturer’s Notification on 

technical characteristics of the 

product, esp. cryptographic security 

- SCRF Import permission. Adding to 

the SCRF List of Radio-Electronic 

Devices 

- RFC import permission 

Can be imported 

Without certificates 

The following production can be 

imported without certificates of 

conformity: 

- goods, which have been already 

used; 

- production imported as spare parts 

for earlier imported 

certificated goods; 

- goods, imported in Russia as 

samples for testing; 

- production which has no commercial 

use. 

Slide 42

Example 

Certificate 


Declaration 



Hygienic 

approval 

10/01/2013 Slide 43 

Declaration 

Telecom 

GSM/GPRS 

Bluetooth 

Wi-Fi 

GPS 

Notification FSS

Information on the World Wide Web 


www.gost.ru 

www.tsouz.ru 

fsa.gov.ru 

10/01/2013 Slide 44

TÜV SÜD 

SÜD Russia 10/01/2013 

Contact us today for 

one-stop quality, safety and 

sustainability solutions. 

Krasnoarmeyskaya str. 10/2 

Moscow, 125167, Russian Federation 

Phone: +7 495 229 18 04 

Fax: +7 495 613 49 79 

E-mail: IS@tuev-sued.ru 

Slide 45

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