Clinical trials are required in Russia to legally sell a medical device. The document outlines the regulatory basis and process for conducting clinical trials in Russia. There are two types of clinical trials - ones conducted on patients and ones involving analysis of literature sources. Clinical trials involve developing a plan, getting ethics committee approval, and permission from regulatory authorities. The applicant must provide documentation on the device and its testing to the medical institution conducting the clinical trials. A program and duration of clinical trials is then coordinated based on the device's purpose and complexity.

1. Conducting Trials at Russian
Government Authorized Testing
and Medical Centers
and Dealing with Roszdravnadzor
and Rosaccreditation Authorities

2. Registration of MDs in Russia
Since Article 38 of the Federal Law №323-FZ came in force on 1st of January, 2013
there are 2 parts of the procedure of Medical Device Registration in Russia
1ST Part:
• Technical Trials and EMS
• Toxicology (Biocompatibility)
• Expertise
2nd Part:
•Assignment of clinical trials
•Clinical Trials
•Expertise

3. Clinical Trials in Russia
• In order to legally sell a Medical Device in Russia, the device must pass a
state procedure called Registration, which is performed to release safe and
high-quality medical devices on Russian Market, and receive a Registration
Certificate of Roszrdavnadzor (Federal Service for Supervision of Health)
• Clinical Trials are vital part of Registration, and it is impossible to receive a
Registration Certificate without conducting them.

4. Clinical Trials in Russia: Regulatory
Basis
 The decree of the Government of the Russian Federation of 27th December
2012 №1416 "On approval of rules of state registration of medical devices“
 The order of the Russian Ministry of Health from 9 January 2014, №2n "On
approval of the Procedure of conformity assessment of medical devices in
the form of technical tests, Toxicological research, clinical trials for the
purpose of state registration of medical devices“
 The order of the Russian Ministry of Health from 8th February 2013 №58n
"On approval of the Regulations on the Board of ethics in the sphere of
medical products circulation"

5. Clinical Trials in Russia: Regulatory
Basis (cont.)
 The order of the Russian Ministry of Health from 1st March 2013 №108 "On
approval of composition of the Board of ethics in the sphere of medical
products circulation“
 National standard “Guidelines for conducting clinical trials of medical
products" GOST R ISO 14155-1-2008 and GOST R ISO 14155-2-2008
 National standard "Assessment of functional characteristics of medical
devices for in vitro diagnostics" GOST R EN 13612-2010

6. Types of Clinical Trials
2 possible forms, just like in EU:
On Patients Analysis of literature sources
•Brand new type of MD
•New unique/special methods
of treatment and diagnostics
•New complex medical
technologies, in case clinical
data evaluation didn’t confirm
the safety and performance of
MD
•All other cases
(Order of Minzdrav of Russia # 2n from 9 January 2014)

7. Analysis of literature sources, basis
Annex A of GOST R ISO 14155-1-2008
Recommendation on analysis of literature sources
• Aim – to create a basis for plan of clinical trials and to help with scientific
justification of clinical trials.
• During this a valuable information is obtained that is used to evaluate the
Risk/Benefit Ratio and to perform clinical trials according to ethical principles.
• Analysis of literature sources also helps to determine if there is enough
clinical data in the literature in order to demonstrate safety and clinical
performance of the MD being evaluated without obtaining new data from
additional clinical trials, or to conclude that there is not enough data available.

8. Analysis of literature sources
• Scientific activity that requires precision and objectivity; its results must be available
for evaluation by the third party.
•The aim must be clearly defined, and types of research that will be used to achieve
this aim must be identified, based on known data on the device.
•Criteria for selection/exclusion of data from recognized scientific publication must be
defined and justified.
•To avoid systematic errors it is also recommended to take into account all available
relevant unpublished data that is appropriate in the given circumstances.
•References to literature and unpublished data, as well as information about the extent
of the search in databases or other sources of information must be listed.

9. Analysis of literature sources,
evaluation of documents
It is necessary to evaluate the quality of documents and the degree of compliance of
the literature data to specific characteristics and properties of the MD being evaluated,
taking into account its intended use.
a) the similarity of the devices in the selected documents with the MD being
evaluated from the point of view of technology, the basic characteristics, design and
principles of operation to assess the applicability of these literature sources;
b) characteristics of a population of patients or test subjects, medical purpose,
indications for use, as well as the severity and type of disease or pathological
condition in the analyzed sources compared with those for the MD being evaluated
c) conditions of use of the MD described in the analyzed literature sources, and the
intended use of the MD that is being evaluated.

10. Analysis of literature sources,
evaluation of documents
During the the analysis of literature sources, it is necessary to evaluate the design of
clinical trials and the significance of published and unpublished data. If the analysis
includes unpublished data, it must be differentiated based on its significance.
The following must be taken into account:
a) If the author’s conclusions is supported by available data
b) If the literature sources reflect contemporary medical practice and the level of
development of relevant technologies;
c) If there are links to widely recognized scientific publications, and if the expert
evaluation of these publications is provided
d) The degree of adherence to scientific principles in clinical trials, based on the
results of which the publication was prepared.

11. Analysis of literature sources, critical
evaluation and report
The analysis of literature must contain its critical evaluation
After the assessment of documents the criteria applied for their selection and
elimination must be justified. A complete analysis should contain the data about the
evaluated MD product and its intended use, and written analysis report must include:
a) Brief description of the product, including its features, type, technical solution,
performance and intended use
b) Analysis of all the selected literature sources and unpublished data, both favorable
and unfavorable
c) A critical assessment of hazards, associated risks and necessary measures to ensure
the safety of patients, medical personnel and third parties;

12. Analysis of literature sources, critical
evaluation and report (cont.)
a) description of approach to determining the significance of the different publications
and applied statistical methods of analysis including the evaluation methods, the
type and duration of the study, and the homogeneity of the population in question.
b) references to the presented list of publications.
c) A justified conclusion with the evaluation of any possible health benefits from the
use of the product described by the manufacturer indications and possible risks,
injuries or illness during this application, given the current level of technology
development.
d) date and signature(s) of author(s) of the analysis.

13. Clinical trials on Human Subjects,
Rationale
• In order to select and justify the optimal design of clinical trials it is
necessary to conduct and document an objective analysis of published
and available unpublished medical and other scientific data and
information. (GOST R ISO 14155-1-2008 Cl.4)
• The decision to conduct clinical trials of medical devices requires, among
other things, the availability of favorable ratio between the expected
benefits from clinical trials and residual risk. (GOST R ISO 14155-1-2008
Cl.4)
• Clinical trials can begin only when the following documents are presented:
1. developed and signed the plan of clinical trials;
2. conclusions and/or approval of the Ethics Committee(s);
3. permission or approval of the authorized bodies (if necessary).
(GOST R ISO 14155-1-2008 Cl.6.6)

14. Clinical Trials
In order to conduct Clinical Trials the following documents are presented by
the applicant to the medical institution:
a) Application for performance of clinical trials;
b) A sample(s) of medical device (excluding MDs installation of which
requires permits (licenses), special conditions, buildings and additional
training and in some cases – visits of specialists to MDs production site;
c) Permit for clinical trials, issued by Roszdravnadzor;
d) Act of evaluation of technical test results with attached documents that
supports results of technical tests;
e) Conclusion on results of toxicological (biocompatibility) tests of medical
device with attachment of documents supporting results of toxicological
(biocompatibility) tests (For MDs that suggest contact with patient’s
body);

15. Clinical Trials (cont.)
f) Results of tests of measuring function (for MDs with measuring function,
contained in list of medical devices with measuring function approved by
Ministry of health of Russian Federation);
g) Data on normative documentation for MD with list of national
(international (Eurasian Economic Union)) standards, requirements of
which the MD complies with (during its use intended by the
manufacturer);
h) Technical and operational documentation of the manufacturer for MD;
i) Photos (general view) of the device together with accessories needed for
its intended use (size no less than 18x24 cm);
j) Documents (materials) containing data on clinical application of MD,
including outside of Russian Federation, including reviews, reports of
completed scientific researches, publications, reports, risk analysis and
methods of application of MD (if available)

16. Program of Clinical Trials
Cl.39 of The order of Ministry of health of Russia dated 09th
January 2014 No. 2N
• When reviewing the documentation submitted for a Medical Device, a
program and duration of clinical trials of the Medical Device is
coordinated. The duration of clinical trials is dependent on the purpose
and complexity of the Medical Device. The clinical trial program is
composed by the applicant together with a medical company that
performs clinical trials of medical devices, in accordance with the
requirements specified in the technical and operational documentation of
the manufacturer and the requirements of regulatory documents.

17. Conformity assessment of medical
devices for in vitro diagnostics
Cl.47 of The order of Ministry of health of Russia dated 09th January
2014 No. 2N
• Clinical trials of Medical Devices for in vitro diagnostics are carried
out in laboratory conditions with the use of biomaterial samples of
patients taken during the diagnostic and treatment process
(hereinafter referred clinical laboratory tests) to check the
functional properties and (or) effectiveness of a Medical Device
when used in accordance with the intended use specified in the
manufacturer's documentation.
• Clinical laboratory tests of medical devices for in vitro diagnostics in
the form of analytical systems conducted in regard to Medical
Devices along with accessories, sets of reagents and calibrators
required for the application of the medical product can be
performed within a single test.

18. Clinical Trials: Organizations
• Order of the Ministry of health of Russia from 16th May 2013 No. 300N
“On approving the requirements for healthcare organizations which
conduct clinical trials of medical devices and procedures to establish
compliance of healthcare organizations to these requirements”
• The full list of organization is located on the official Roszravnadzor’s
website : http://www.roszdravnadzor.ru/services/clinicaltrials

19. Clinical Trials: Organizations (list)

20. Clinical Trials: Final Report
Cl 11. of GOST R ISO 14155-1-2008 : Presentation of results:
• Drafting of the final report of clinical trials is mandatory, including in
the event of early termination of clinical trials.
• The final report must be made in written form. It is signed by the
organizer and the coordinator (if one has been appointed) and the
head of clinical trials at each research centre.
• Final report on clinical trials should include complete identification
data of the item(s), a description of the methodology and design of
clinical trials, all deviations from the plan of clinical testing, data
analysis, including statistical analysis, and critical evaluation in relation
to the objectives of clinical trials

21. Clinical Trials: Pitfalls
• All of clinical trial medical facilities are located mostly in central part of
Russia, very few are scattered across the rest of the country.
• Even fewer of those rest are capable of performing Clinical Trials for
your type of device.
• In some clinical facilities, even though the type of your device is listed
among those that this facility can perform clinical trials for, in reality,
the facility might refuse, so, at first, you need to make sure that the
facility can perform trials by phone call.
• If the medical device does not have analogues in Russia, it will be
difficult to perform Analysis of literature sources for it, even if
analogues exist in other countries. Most likely, Clinical trials with
human subjects will be required.

22. Group STM
• Our own laboratory, accredited by Roszdravnadzor for performance of
technical trials for the purpose of Registration of MDs.
• We carefully trace all changes in the Russian certification system and
keep our clients informed.
• We speak your language.
• We are experienced in both Russian certification requirements and
International production standards.
• We are flexible and customer oriented.
• We will discuss and offer the best certification schedule reflecting your
needs and capabilities.
• We are friendly and like to solve your problems!

23. CONTACTS
Anton Dulov, Manager Coordinator
E-mail: dulov@group-stm.ru
Phone/fax: +7 (495) 981-44-84
Cell ph: +7 (916) 216-45-77
www.group-stm.ru