SUMMARY
This report briefly reviews
the Russian medical equipment, devices and supplies market and analyzes the
opportunities for U.S. manufacturers and
suppliers in that market. In the last
three years the Russian medical equipment and devices market has shown
substantial and steady growth with annual rates exceeding 10 percent. The total
volume of the market is estimated at approximately 1 billion dollars. For comparison the U.S. medical equipment
and supplies market in 2000 was 75 times larger and amounted to 75 billion
dollars, of which 10 billion dollars was reinvested in R&D.
The 1998 economic crisis
served as a spur for a number of Russian medical equipment and device
manufacturers which, having taken advantage of the sharp rise in price of
imported medical equipment, managed to increase their share of the total
market. However, in general, imported
medical equipment and supplies still play a predominant role and currently
supply 71 percent of the total market. Despite the fact that the quality of some
of the medical devices and supplies produced in Russia is highly
improved, it is in many cases not up to comparable foreign products. Foreign-made high-end medical equipment,
sophisticated medical devices and many medical products and supplies in the majority
of cases do not have Russian analogs.
The United States is the second
leading supplier of medical equipment to the Russian market after Germany. Other important suppliers include Japan, Italy and France.
Russia still does not
have a developed legislative basis for the medical device and equipment market.
The Law on Medical Equipment and Devices has over several years been discussed
in the Duma, the lower chamber of the Russian
Parliament, but has not yet been adopted.
There are a number of regulatory documents, including orders and
instructions issued by the Ministry of Health of the Russian
Federation, regulating different aspects
of the licensing, registration and certification processes. However, the state registration, licensing
and certification processes need to be reformed to become less lengthy and
expensive and more transparent. This
report focuses on the following major product lines: electro-medical equipment;
surgical and diagnostic instruments and apparatus; infusion and transfusion
equipment; clinical laboratory equipment and supplies; ophthalmology equipment
and instruments; endoscopes and laser instruments; orthopedic equipment;
wheelchairs and rehabilitation equipment.
End summary.
A. MARKET HIGHLIGHTS & BEST PROSPECTS
Market Profile
According to the medical
industry analysts’ estimate, the total volume of the Russian medical equipment
market in 2001 was about 1 billion dollars. The total market growth rates for
the last three years have exceeded 10 percent annual growth. Medical industry analysts predict steady
growth of the market for the next five years.
In the last three years due to
a sharp increase in price for imported goods as a result of the 1998 economic
crisis local manufacturers were able to increase their share in a number of
market segments, including electrocardiographs, patient monitors, X-ray
devices, anesthesia and pulmonary equipment, ultrasound scanners, devices and
instruments for endoscopy and laparoscopy as well as
electrosurgical instruments. Stronger
positions were also achieved in home healthcare products, orthopedic devices,
ophthalmic products, test kits, polymeric and glass medical products,
disposable syringes and other disposables.
Generally, Russia has a strong
manufacturing basis in the areas of traditional and mass medical equipment and
devices, including such groups as traditional diagnostic X-Ray equipment, MRI tomographs, anesthesia and pulmonary equipment,
electrocardiographs, blood pressure meters, eye pressure meters, endoscopes,
electrosurgical and surgical instruments, artificial blood circulation devices,
physiotherapy devices, altitude chambers, clinical laboratory instruments, and
sterilizers. However in medical equipment
industry subsectors which have a large R & D
component, and which use innovative, sophisticated technologies and automation,
Russia is behind the
majority of developed countries. Such
industry subsectors include high-end ultrasound
equipment, computer and X-Ray tomographs, angiography
systems, devices for array therapy, resuscitation equipment, fuctional diagnostic equipment, implants and prostheses,
robotics clinical laboratory systems for express microanalysis, telemedicine
complexes, hospital equipment and supplies, operation room equipment, many
types of home healthcare equipment and supplies, infusion and transfusion sets,
and IV solutions.
Domestic production supplies
only 29 percent of the market. Imports
account for about 71 percent. In 2001
domestic production was growing slower (at 6.4 percent) than imports (15
percent).
The medical equipment used in
Russian hospitals and clinics is very old.
Eighty percent of the medical equipment is worn-out and has surpassed
the established term of safe and efficient functioning and needs replacement. The major obstacle towards renovation of the
existing medical equipment resource is lack of financing on federal and
regional levels. Servicing of medical
equipment forms a significant market, the demand for quality maintenance and
repair services is high. The main
organization in the area of servicing medical equipment is the Russian
Association of Enterprises Specializing in Sales and Repair of Medical
Equipment (RAPMED).
Russian statistical and
regulatory bodies use specific classifications of medical goods which are
different from classifications adopted by the Western countries. According to the Ministry of Industry,
Science and Technology, from the point of view of production, all medical goods
are divided into five major categories:
- Medical Apparatus (41 percent of the total market);
- Medical Equipment (12 percent);
- Medical Instruments (24 percent);
- Medical Goods made of Polymeric and Glass Materials (6
percent);
- Medical Purpose Supplies (19 percent).
In fact the first three
categories basically include different medical equipment and devices while the
last two cover medical supplies.
For registration purposes the
Ministry of Health divides all medical goods into two major categories: medical
equipment and medical items depending on the materials which make up the
product. In fact, the medical equipment
group unites all types of equipment, apparatus, instruments and devices while
the medical item category includes basic supplies. In practice, there is no clear criterion to
determine whether the item belongs to the medical equipment or the medical item
category. However, the assigned category
is very important for suppliers and distributors of medical products as it
affects the validity of the registration certificate. For the medical equipment category the
validity is 10 years while for supplies the registration certificate is only
valid for 5 years. In addition,
depending on the category, different VAT tax rates are applicable: for the
majority of equipment there is no VAT tax at all while for medical supplies it
is 10 percent.
The existing division of
medical equipment into two groups (medical equipment itself and medical items,
or supplies) causes confusion at customs points. The customs authorities refer to the
duration of the registration certificate issued by the Ministry of Health as a
basis for determining the VAT rate. If
the duration of the certificate is 10 years, the product is VAT-exempt, but if
it is 5 years, then they impose a 10 percent VAT. Because the distinction between medical
equipment and supplies which the Ministry of Health uses when it registers the product, is not clear-cut, some medical equipment items may
be registered as supplies. However, the
same products are considered medical equipment according to the General Classification Codes
(OKP system), a classification system used by the Russian Government. They are also included in the list of vitally
important medical equipment issued by the Russian Government and exempt from
VAT. Despite the above mentioned facts
the customs authorities often question whether the medical product is subject
to the VAT exemption or not. The
division of medical equipment into two categories used by the Ministry of
Health results in misunderstanding, arbitrary decisions and delays at customs
points. The State Customs Committee, instead of enforcing the Ministry of
Health regulations, interprets the classification of devices in its own fashion
without consultations with the Ministry and in many cases to the detriment of
the importer.
Classification systems used in
Russia contribute to the
fact that the whole regulatory system is less adapted to the general trend
towards harmonization of global approaches to regulating the medical device
industry and make it more difficult for the Russian medical equipment industry
to be more involved in international trade.
Statistical Data
Medical
Equipment, Devices And Supplies
Market Size Table Format
(Us Dollars Millions)
|
|
Last Year
2001
|
Current Year 2002
|
Next Year
2003
|
Projected avg. annual
growth rate for following 2 years
(2003-04) %
|
|
Import Market
|
750
|
830*
|
910*
|
15
|
|
Local Production
|
309
|
350*
|
380*
|
15
|
|
Exports
|
50
|
60*
|
90*
|
15
|
|
Total Market
|
1,009
|
1,120*
|
1,200*
|
10
|
|
Imports from
U.S.
|
160
|
180*
|
190*
|
10
|
|
Exchange rate
|
30.7
|
31.5*
|
NA
|
|
* Unofficial estimates
2001 Import Market
Share (Percent for U.S. and Major Competitors)
|
Germany 46%
USA 22%
Japan 9%
Italy 5%
France 5%
Other 13%
|
Estimated Future Inflation
Rate: 14%
SOURCES: Customs Committee
Foreign Trade Statistics, Moscow, State Customs
Committee of the Russian Federation, 2001; FGYP NIIEMP
(Institute of Economic Problems of Medical Industry}
Best Sales Prospects
Many types of medical
equipment and devices are either not produced locally or are inferior to
Western analogs. The best sales prospects in the Russian medical equipment,
devices and supplies market include:
- high-end ultrasound equipment;
- computer and X-Ray homographs;
- angiography systems;
- devices for array therapy;
- resuscitation equipment;
- fuctional
diagnostic equipment;
- implants and protheses;
- robotics clinical laboratory systems
for express microanalysis;
- telemedicine complexes;
- hospital equipment and supplies;
- operational room equipment;
- many types of home healthcare
equipment and supplies;
- infusion and transfusion sets;
- IV solutions.
B. COMPETITIVE ANALYSIS
Domestic Production
In Russia medical equipment
and devices are manufactured at 1,275 enterprises, including 32 specialized
medical device enterprises controlling 60 percent of the total output, 300
defense plants and 900 small and medium enterprises having federal licenses for
production of medical equipment and devices.
A significant portion of high-tech medical equipment is still developed
and produced at defense enterprises, which have traditionally had access to
advanced technologies. According to medical industry expert estimates, local
production supplies only 29 of the total medical equipment market.
Domestic production of medical
equipment and supplies has been growing steadily over the last several
years. In 2001, for example, it grew by
14 percent. The most dynamic subsectors included
devices for endoscopy, laparoscopy, electrosurgical
instruments, polymeric and glass medical products, disposable syringes and
other disposable products.
In the last two to three
years, because of the change in demand from imported to locally produced medical devices and supplies as well as some types
of equipment, a significant number of Russian enterprises managed to strengthen
their positions and increase their share in the market. Russia started to develop
and launch into production new types of advanced medical equipment and
instruments used in diagnostics and treatment of serious diseases. Such
equipment and devices include:
- Artificial kidney devices with non-kidney blood clean-up (Avangard Electromedical Plant in Sarov);
- Medical monitors (Triton Elektronika
Ltd. In Yekaterinburg, NIOTK Scientific and Proudction
Fund in Izhevsk, VNIIMP-VITA Closed Joint Stock
Company in Moscow, Avangard Open Joint Stock Company
in Saratov, and Elips Open
Joint Stock Company in Istra, Moscow Region);
- Electrocardiographs (Gelpik Open
Joint Stock Company in Moscow);
- Endoscopic and Laparoscopic Equipment
(Efa Open Joint Stock Company, Optimed,
Aksioma Open Joint Stock Company, Azimut
Open Joint Stock Company, LOMO Open Joint Stock Company in St. Petersburg, Endomedium Scientific and Production Fund, PPP Ltd. In Kazan, Fotek Open Joint Stock
Company in Yekaterinburg);
- MRI Tomographs (AZ Scientific and
Production Fund in Moscow);
- Digital X-Ray Equipment for Fluorographical
Tests and TB Diagnostics (Spektr AP Ltd., Gelpik Ltd., Medical Radiology Scientific and Research
Center, Mosremtgen Open Joint Stock Company in
Moscow);
- Ultrasound Medical Scanner ( Izomed Ltd.);
- Microtron M-01 Automated Medical
Complex for Array Therapy (Scientific and Research Institute named after Gerzen);
- Cardiostimulators and Cardioelectrods (Elistim Cardio
and VNIIMP-VITA Closed Joint Stock Company in Moscow);
- Hearing Aids (Audit-RR in Fryazino,
Moscow Region, Rythm Ltd. In Moscow);
back
- Hemoglobin Meters for Diabetes (Technomedica,
Moscow);
- Sterilizers (TZMOI in Tyumen, Kasimovsky Priborny Zavod);
- Operation Room Lights (Uralsky OMZ
in Yekaterinburg and VNIIMP-VITA ZAO in Moscow);
- Instruments for Microsurgery and Ophthalmology (GUP VNIPIMI
and Kazansky MIZ in Kazan);
- Hip Implants (GUP VNIPIMI, Kazan) .
The above mentioned recently
developed medical equipment and devices are successfully competing with their
Western equivalents within the country due to high technical standards and
relatively low price. Generally only 25-30 percent of medical equipment
produced in Russia can compete
internationally. Locally made medical
equipment and devices are from three to five times less expensive than similar
Western equipment, although they are sometimes inferior to Western medical
equipment in terms of design, efficiency and after-sale services.
Russia has been recently
developing important technological equipment and lines used in production of
medical equipment. Such technological
lines include automatic equipment to produce needles for disposable syringes
(TZMOI, Tyumen), technology to
sharpen cutting instruments and forceps made of titanium, technology to put
biologically inertial coating on medical instruments, new technology in glass
lenses, including protective lenses for work with computers, glasses for
drivers who drive in conditions of limited vision and light, etc.
Russia still does not
produce many important technological lines which are in demand by local
manufacturers. This includes automatic
lines to produce disposable syringes, IV solutions, transfusion and infusion
sets, and test kits.
Russia has proclaimed a
gradual upgrade of the medical industry to Good Manufacturing Practice (GMP)
standards by 2005. However, lack of
financing as well as insufficient experience and education on GMP can delay the
transition of the industry to GMP standards beyond the proclaimed goals.
Third-Country Imports
Third country medical
equipment and devices imports mostly come from Germany (46 percent), Japan (9 percent), Italy (5 percent) and France (5 percent). In general imports dropped substantially
after the 1998 economic crisis. In 2000
imports were 470 million dollars while in 1998 they were 952 million
dollars. The 2001 figure of 750 million
dollars is still less then the level achieved before the crisis.
U.S. Market Position
The United States is the second
major supplier of medical equipment to the Russian market. Leading U.S. manufacturers of
medical equipment represented in Russia, including General
Electric Medical Systems, Agilent Technologies (now
Philips Medical Systems), Accuson,
Valtex, Varian, Picker, Striker, Becton Dickinson and
others.
Inadequate protection of
intellectual property rights (IPR) is a critical deterrent to foreign
investment in Russia and has been a
burning issue for foreign, including U.S., businesses
operating in Russia in the last few
years. On the highest level, Russia has signaled its
commitment to protecting IPR. Russia is a signatory to
several international agreements that require compliance to international
standards of IPR law and enforcement. Russia has also made
significant progress in introducing laws to ensure IPR compliance. However, IPR law enforcement is still rather
poor. Especially low is the ability of Rospatent, the Russian Patent Office, to annul illegal
registrations of trademarks and to implement court and Anti-Monopoly Ministry
decisions.
Foreign trademark recognition
and protection is an important issue.
Trademark infringement and counterfeiting are everyday facts, which
remain a challenge to brand holders and trademark owners in Russia. Foreign companies are recommended to
register their trademarks in Russia. Otherwise, in case of counterfeiting they are
most likely to lose court cases because the Russian courts would be very
protective of the trademarks registered in Russia, even though they
may belong to foreign manufacturers and be registered illegally in the name of
Russian agents or distributors.
C. END-USER
ANALYSIS
The main end-users of medical
equipment are clinics and hospitals. In
the majority of cases they can only afford to buy supplies and small medical
devises using their own finances.
Purchases of expensive medical equipment are usually financed by federal
and local health budgets. The role of the federal government in financing medical
equipment purchases has diminished significantly while the role of local
governments has increased. Local
governments are attempting to modernize hospitals and clinics, located in their
territories and subordinate to the local governments, by equipping those
hospitals with modern equipment. Local
health care authorities arrange a number of tenders to buy medical equipment
and supplies for their territorial hospitals and clinics. The list of tenders are
published on a regular basis in a special magazine called Competitive
Bids. Foreign companies are allowed to
take part only in some of the tenders either directly or through their local
distributors. Funding of equipment and
services of private clinics is self-financed.
Major hospital modernization
projects have been until recently financed by foreign credits and international
financial organizations such as the World Bank.
The World Bank is completing a number medical equipment projects,
including the Health Reform Pilot Project for Kaluga and Tver oblasts and the Community Social Infrastructure
Project for Novosibirsk and Rostov oblasts. These projects involve several stages,
including renovation of medical facilities, the purchase ofambulances,
and supplying medical equipment. Some of
the tenders are completed, some are on-going and some will be announced in the
future.
U.S. Eximbank
works on a number of hospital modernization projects in Russia. Overall since
1999, Ex-Im Bank has financed $341.9 million in U.S. medical equipment
exports. In fiscal year 2002, Ex-Im Bank authorized $156.7 million in financing to support a
wide range of U.S. exports to Russia, from sewing
equipment to engineering services and equipment for a refinery upgrade to
hospital and medical equipment.
D. MARKET ACCESS
Import Climate
Current Russian legislation is
not a significant barrier to importers of medical equipment. Customs duties for
the majority of these products are currently 5 percent. Exceptions concern IV sets, and disposable
syringes for which customs duties are 15 percent. Jacuzzi baths and medical thermometers are
subject to 10 percent customs duty.
The new Tax Code, which came
into force on January 1, 2002, discontinued the
VAT exemption for a large number of medical products, including
pharmaceuticals, substances, medical supplies and some types of medical
equipment. However, the new regulation
did not affect vitally essential medical equipment. On January
17, 2002 the Russian Government issued a Resolution on the List of Approved
Important and Vitally Essential Medical Equipment which is VAT exempt while
being sold in Russia. The list includes the following medical
equipment, instruments and devices:
- mechanical instruments;
- piercing instruments;
- cutting instruments and beating instruments with sharp
cutting edges;
- pressing back instruments;
- probing and bougieuraging
instruments;
- medical kits;
- trauma instruments;
- functional diagnostics and measuring
instruments;
- instruments and devices for
diagnostics except measuring ones. Glasses.
- biological microscopes;
- medical radiology devices;
- devices and instruments for clinical
laboratory research;
- devices and instruments for
anesthesia. Devices for organ functions
and systems replacement;
- platform medical scales;
- table medical scales
- sanitary and hygienic equipment,
patient lifting and moving equipment;
- equipment for doctor’s offices and
wards, clinical laboratories and pharmacies
The above list does not
include syringes, sunglasses, optical glass frames and lenses, protection masks
and glasses.
REGISTRATION OF MEDICAL EQUIPMENT AND DEVICES
According to Russian law, all
medical equipment and supplies should be registered with the Russian Ministry
of Health before being imported, sold and used in the territory of the Russian
Federation. In June 2000, the Ministry of Health issued a
new Instruction #237 on Registration Procedures for Foreign-Made Medical
Equipment and Devices, which introduced several changes into the registration
process. Under the new instruction, the
registration procedure is governed and controlled by the Department of State
Control over Quality, Efficiency, and Safety of Drugs and Medical Equipment of
the Ministry of Health. The Department
issues the registration certificate and enters the registered device or
equipment in the State Registrar.
The registration procedure
involves submission of the necessary documents and the carry out of tests on
the actual equipment or device, including technical, toxicology, hygienic,
clinical and other. The Department works
with a number of expert commissions, which assist in deciding which tests should be assigned and where they should be
conducted. These tests are conducted by
a number of expert institutes, laboratories and clinics. The above mentioned organizations do not have
clearly defined, standard operating procedures, which makes the process lengthy
and biased. The fees for the trials are
in most of the cases negotiated on a case by case basis. As for the duration of tests, they often last
more than three months set by the Instruction #237. By the new rules, the applicant must submit
more documents, and the product should undergo more tests than before. Most of the documents should be translated into
Russian. This leads to additional expenses for the manufacturer or its authorized
Russian representative and a longer registration procedure.
Following are the documents
necessary for registration of medical device or equipment:
1. A letter from the manufacturer proving his intent to register a product/products on a company letterhead. The letter should be in the manufacturer’s
native language with a Russian translation.
2. An application for registration
(re-registration) of a medical device/equipment on the Applicant’ letterhead. The application should contain, if necessary,
the exact and complete description of the product components. The application letter should either be in
Russian or followed by a Russian translation.
3. A Power of Attorney to an authorized representative to conduct
registration. It should be given to a
legal entity (addressed to the head of the company) and notarized in compliance
with the current legislation. The Power
of Attorney should be legalized in the country of the manufacturer’s origin. If the country is part of the Hague Convention
of 1961, the application should have a special stamp called Apostille. The Power of Attorney should state that the
manufacturer entrusts the Applicant to conduct the registration of a medical
device/equipment, sign a consultative and expert works contract and receive the
registration certificate.
4. The information on the medical device/equipment. It should contain a brief description of its
usage as well as information on when it was developed, launched into production
and which world markets it is supplied to.
The document should be prepared in Russian or have a Russian
translation.
5. A picture of the medical device/equipment (not smaller than
130x180 millimeters). The picture should
reflect the appearance of the device and its components.
6. Advertising illustrative materials. Can be provided in a
foreign language.
7. Documents on registration of a medical device/equipment in the
country of origin.
8. Documents on the registration of a product in the country of
origin as a measurement device.
9. National or international documents confirming the conformity
of medical devices/equipment to the requirements of national and international
normative documents and describing the manufacturing process.
10. Manufacturer’s operational manual in Russian
Documents in the items 7, 8
and 9 should be originals or notarized copies which have undergone legalization
and have an Apostille.
The Ministry of Health
identifies the testing centers that can perform technical and toxicology tests
for a specific product. It works with
approximately 30 such centers. The
leading testing institution approved by the Ministry of Health to conduct
technical tests is VNIIMP Scientific and Research Institute. Hygienic
assessment is implemented by the Department of State Sanitary and
Epidemiological Surveillance of the Ministry of Health which based on the
results of the tests issues hygienic conclusions. Measurement devices undergo special tests to
prove that they can be used as measurement means. Clinical tests are performed by about 130
clinics and medical institutes authorized by the Ministry of Health upon
completion with positive results of respective technical and toxicology tests
as well as hygienic assessment.
In order to undergo tests a
sample of the equipment or device must be imported into Russia. To be able to
bring a piece of equipment or device into the country the manufacturer or its
authorized representative should apply to the Ministry of Health and get the
appropriate permission to present at the customs point. The same rules apply when equipment is
brought into the country for showcasing at an industry exhibition. There are also special rules for temporary
import of equipment. In that case the
recipient should obtain a special cargo declaration for temporary import from a
customs broker. In the absence of the
above mentioned documents and negative resolution by the customs authorities,
the equipment has to be exported back to the country of origin.
According to Instruction #237
the registration process should take not more than a week after the receipt of
the results of all necessary tests.
Registration is conducted at costs ranging from two hundred to several
thousand dollars. For some types of
equipment, devices and supplies there is a fixed tariff while for others the
tariff is calculated at a rate of 5 percent of the cost. For expensive, complex equipment such as
anesthetic and respiratory devices, artificial blood circulation devices, accelerators,
computer tomographs, laser equipment, dental
complexes, laboratory analyzers, hospital equipment, etc., registration fees
might be considerable. For disposable
systems and smaller devices like test kits, sutures, or surgical gloves,
certification costs vary from two hundred to two thousand five hundred dollars.. Registration
certificates must be renewed every two years.
The term for registration certificates for medical equipment, devices,
instruments, plants, medical furniture is 10 years, while for medical supplies,
including reagents and disposable items is 5 years. Re-registration is necessary in the following
cases:
- Expiry of the registration certificate;
- Change of the manufacturer’s name
- Change of the product name;
- Change of the manufacturer of the registered product.
The Ministry of Health
generally does not have a tradition of posting new official regulatory
documents on its web site in a timely manner.
The newly created Department of State Control over Quality, Efficiency,
and Safety of Drugs and Medical Equipment web site has been developed to fill
in this gap. The web site is located at
the following address: www.regmed.ru
CERTIFICATION OF MEDICAL EQUIPMENT
Imported medical equipment and
devices should conform to Russian quality and safety standards, which are set
by Gosstandart.
Gosstandart ensures product conformity through
a system of end product certifications. Gosstandart also maintains and updates annually lists of
goods and services which are subject to obligatory certification and
metrological control in Russia, and authorizes a
number of national and several international testing institutes to issue safety
and quality certificates, or GOST R certificates. Safety certificates requested by
manufacturers of medical devices usually are issued for longer terms - up to
three years. Certificates sought by
distributors or trading companies are usually issued for shorter terms - up to
one year. The testing company will
require that the distributor or trading firm submit their contract with the
manufacturer. Certificates of conformity
issued by Gosstandart can have a large coverage,
including not only groups and shipments of similar products produced by one
manufacturer in compliance with the same requirements, but also components and
spare parts used for maintenance and repair.
In such cases, one certificate is sufficient to have the right to sell
both products and spare parts in Russia.
Medical equipment and devices
are actually subject to mandatory double certification by the Ministry of
Health and Gosstandart. In order to get the above certificates the
company has to conduct product tests which are practically identical
twice. There is no agreement between the
Ministry and Health and Gosstandart on recognition by
the Standards Committee of technical tests conducted by the Ministry of
Health. The GOST R certification system
exits separately from the Ministry of Health registration procedure. The two systems duplicate each other creating
additional costs. In addition, serial
certification of medical equipment and devices involves the travel of Russian
standards experts to foreign production sites, the cost of which is born by the
manufacturer.
The GOST R certificate
along with the registration certificate are the two major documents
checked by the customs authorities when goods cross the country’s borders. The
customs points are still not equipped with the electronic version of the State
Registrar of Medicines which they can refer to in conflict situations. Sometimes, the customs authorities question
certificates issued by the Ministry of Health and Gosstandart
which cause unnecessary delays in customs clearance and costs.
Russia has started to
gradually introduce ISO (International Organization for Standardization) and
IEC (International Electro-technical Commission) standards into the production
of medical equipment. With full introduction of the new system Russia will have to
introduce new certification procedures.
So far adherence of a foreign product to ISO 9000 or ISO 14000
manufacturing standards is not accepted as confirmation of product conformity
with the Russian GOST R certification standards. Rather, manufacturers must submit finished
products for testing to an accredited third party certification
organization. Based on test protocols
and results, a certificate of conformity may be issued on a single item or on a
lot. Serial production certificates are
issued for a maximum of three years, and in the case of serial production,
follow-up testing is generally required.
As registration and
certification procedures involve direct personal contact with respective
Russian government entities as well as substantial time and paperwork, U.S. companies are
recommended to effectuate both procedures either through an accredited
representative office in Russia or through a hired
Russian or foreign agent or distributor.
U.S. companies are also
recommended to use services of consultants specializing in preparing
documentation for registration of pharmaceuticals and medical devices.
To the best of our knowledge,
the information contained in this report is accurate as of the date published.
However, the Department of Commerce does not take responsibility for actions
readers may take based on the information contained herein. Readers should always conduct their own due
diligence before entering into business ventures or other commercial
arrangements. The Department of Commerce
can assist companies in these endeavors.