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CERTIFICATION OF MEDICAL DEVICES IN RUSSIA

CERTIFICATION OF MEDICAL DEVICES IN RUSSIA Medical devices and pharmaceutical exports to Russia are free from any trade sanctions and counter sanctions: “free for business”. The current export value of pharmaceuticals and medical devices from Western countries to Russia in 2018 is about US$ 18 Billion/year or over 15 milliard Euro/year, and growing fast. Its share 18% of all  is one of the biggest sectors of all product segments imported to Russia. Over 80% of all medical devices in Russia originate from the Western countries. This situation will last for a very long time also in the future. There is very little local manufacture of medical devices in Russia, and no strong development in this sector.

WHAT IS CONSIDERED A "MEDICAL DEVICE"

Practically all products used in the “medical theater” are categorized as a medical device and need to have a product registration in Russia. Certificate is issued by RZN  Roszdravnadzor.

In Russia there are four classification tiers for medical devices: (1) Class I  low/medium risk, (2) Class IIa  medium risk, (3) Class IIb medium/high risk and (4) Class III high risk. System is very similar to medical device classification in the USA and European Union. Registration requirements vary slightly depending on the classification, and especially for Class I devices. Time needed for certification is shortest for Class I devices and longer for devices in categories from Class IIa to Class III. Acquired certification is valid indefinitely. Typical examples of each Class are:

Class I: low risk                         Bandages, walking aids, oral spatulas

 

Class IIa: medium risk               Dental fillings, contact lenses, ultrasound, hearing aids

 

Class IIb: medium/high risk       X-ray devices, dental implants, monitoring screens, defibrillators

 

Class III: high risk                       Heart valves, hip implants, drug eluting products, etc

 

HOW THE CERTIFICATION COST IS DETERMINED

A typical and simplified illustration of a certification cost breakdown of a standard level Western medical device is as follows:

1.        Technical  tests                 120.000 roubles   10%                     (~1.700 euro)      

2.        Compatilibity tests             65.000 roubles     6%                      (~ 930 euro)

3.        Technical file preparation   105.000 roubles   10%                     (~1.400 euro)

4.        Medical tests                    390.000 roubles   34%                      (~5.570 euro)

5.        Licensed agencies             360.000 roubles   31%                     (~5.140 euro)

6.        State duties & taxes            85.000 roubles      7%                      (~1.210 euro)

7.        Registration certificate         30.000 roubles      3%                        (~430 euro)         

8.        TOTAL                               1.155.000 roubles100%                    (~16.500 euro)

Cost elements include many subcategories for various kinds of procedures by authorized organisations in Russia. Total costs  increase with the evaluated complexity of each specific medical device. In Class III device segment the total cost may by up to 35.000 euro (~US$ 42.000). A very large portion of medical devices belong to Class I and Class II.

There does not exist any kind of "exact price list" for certification costs of medical devices. Each device will be evaluated separately by state authorized agencies for certification requirements. There may be requirements of toxicological tests, electromagnetic compatibility EMC tests, hygienic tests, various types of medical tests, technical tests, etc. The number and type of tests required will finally form the total cost.

Testing process is transparent and the procedures and methods used are on a high professional level. These mandatory tests are the most time consuming element in the certification process. Russia relies on in-country testing and clinical data in Russia to approve medical devices, even if the device is already certified, sold  and used in other major markets. It means in-country testing in Russia is mandatory and remains mandatory even in the future. It is the very cornerstone of the Russian regulatory process.

Russia`s RZN has it´s own Expertise Center. It  recommends and decides the type of testing and clinical data necessary for each medical device.

Before starting the registration process, it is recommended to acquire an official evaluation and quote for the medical device in question.  This will provide information on the Russian classification of the device, registration process, tests required, expected duration,  and cost and total budget including translation and notary expenses. 

CERTIFICATION AND VALUE ADDED TAX TREATMENT OF THE DEVICE

Once the Registration Certificate is issued, the medical device in question can be imported to the Russian Federation.  Some medical devices are fully exempt from value added tax, some can be imported at a reduced VAT rate and some are subject to normal VAT. Lists of devices and their VAT treatment are updated from time to time.

Practically all and every product used in so called “medical theater” is categorized as a medical device and it needs to have a certificate and registration.

HOW FOXX CAN OPEN THE RUSSIAN MARKET FOR YOUR PRODUCTS

FOXX is a Finnish business consulting company. FOXX has it´s own subsidiaries in Russia and the other "former USSR countries" since 1992. In Moscow,  FOXX-Russia is located inside the building complexes of The Russian Academy of Medical Sciences since 1993. The Academy is responsible of medical and healthcare matters of the entire of Russia. It has its own hospitals, R&D institutes and centers, clinics, laboratories and units authorizing the certification organisations for medical devices and pharmaceutical products.

FOXX provides business services to Western companies for Russia. In medical business & industry typical services provided by FOXX are:

·   Certification of medical devices and equipment for importing and selling products in Russia

*  Providing official evaluations and quotations for price and procedure of certification

·   Sourcing and selecting distributors and importers for Western company in Russia

·  Market studies, including establishing contacts with important customers in Russia

·   Outsourced local sales personnel to enforce selling, marketing and customer contacts in Russia (without any need for establish own company in Russia)

Western medical device, equipment and pharmaceutical business and industry will increase successfully in Russia in many years to come. We would be delighted to offer and provide our business services to your company`s specific needs for business and exports in Russia. 

for more information FOXX COMPANY