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Update Nov 03, 03
INTERNATIONAL NEWS UPDATE
RUSSIA: REGISTRATION AND CERTIFICATION OF MEDICAL EQUIPMENT
We recently came across an article on the requirements for the
exportation of medical equipment to Russia. It as quite interesting and we
thought that as the world gets smaller and we are looking for more places
to sell your devices, that maybe Russia maybe the next frontier.
We will try to provide the highlights of the article:
Russia still does not have a developed legislative basis for the
medical device and equipment market though there is governmental
discussion on adapting such regulations. This does not mean that you could
just sell your medical devices to Russia. 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
registration and certification processes. So as with any newly formed
bureaucracy, this process could be lengthy and expensive, not unlike what
the US has in place but the Russian process is not as transparent, making
it much harder to understand what is required.
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 Russian government will require similar testing that is now
required by the MDD as well as the FDA but what testing is necessary for
what devices and where it is to be conducted is left to a number of expert
commissions. These tests are performed 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 and there is no structured fee schedule leaving a lot
to your negotiation skills. As for the duration of tests, they often last
more than three months as specified in Instruction #237. Most of the
documents should be translated into Russian.
Following are the documents necessary for registration of medical
devices or equipment:
- 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.
- An application for registration (re-registration) of a medical
device/equipment on the Applicant’s 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.
- 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.
- 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.
- A picture of the medical device/equipment (not smaller than 13x18
cm). The picture should reflect the appearance of the device and its
components.
- 6. Advertising illustrative materials. Can be provided in a foreign
language.
- Documents on registration of the medical device/equipment in the
country of origin.
- Documents on the registration of the product in the country of
origin as a measurement device.
- National or international documents confirming the conformity of the
medical device/equipment to the requirements of national and
international normative documents and describing the manufacturing
process.
- Manufacturer’s operational manual in Russian.
Documents in items 7, 8 and 9 should be originals or notarized copies
with an Apostille.
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 declared value. 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 are
likely to 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, and medical furniture is 10
years, while for medical supplies, including reagents and disposable
items, the term is 5 years.
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 systems, 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 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 advised to conduct both procedures
either through an accredited representative office in Russia or through a
hired Russian or foreign agent or distributor.
As you see, it will not be an easy process of selling your medical
device into Russia and until the Russian Government makes this process a
lot more reasonable the Russian people will have to deal with the devices
that have been home grown for a long time to come.
Any comments and questions please email us at info@mdiconsultants.com
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