2. Medical institutions in Russia
•Each clinic must me accredited by Roszdravnadzor to receive
the right to perform clinical trials.
•The list of accredited medical institutions conducting clinical
trials of medical devices can be found on Roszdravnadzor’s
official website at:
http://www.roszdravnadzor.ru/services/clinicaltrials
3. Main Medical Institutions
• Since the bulk of medical institutions are located in central part
of Russia, It’s preferable to apply for clinical trials in them.
• They tend to have wider specializations than most of medical
institutions, so it is more likely that they will be able to perform
clinical trials for your type of Medical Device.
• Those organizations also tend to perform clinical trials in shorter
times than the rest.
4. Roszdravnadzor
Federal service for surveillance in healthcare (Roszdravnadzor) is formed in
accordance with the decree of the President of the Russian Federation of 9th March
2004 No. 314 "About system and structure of Federal bodies of Executive power"
and is a Federal body of Executive power exercising functions on control and
supervision in sphere of public health.
Roszdravnadzor is the responsibility of the Ministry of health of the Russian
Federation and is guided in its activities by the Constitution of the Russian
Federation, Federal constitutional laws, Federal laws, acts of the President of the
Russian Federation and the government of the Russian Federation, international
treaties of the Russian Federation, acts of the Ministry of health of the Russian
Federation, and the Regulation "on the Federal service for supervision in the sphere
of public health", approved by the government decree of the Russian Federation №
323 dated 30th June 2004.
5. Accreditation of Medical Institutions
by Roszdravnadzor
• Roszdravnadzor performs accreditation of medical institution
for conduction of clinical trials based on the medical
institution’s specialization.
• Roszrdavnadzor creates and maintains a list of all medical
facilities in the country that are accredited to perform clinical
trials.
6. Accreditation of Medical Institutions
by Roszdravnadzor
Medical institution that is planning to conduct clinical trials submits an application
to Roszrdavnadzor about its intentions to perform clinical trials.
The statement about the intention to conduct clinical trials of medical devices shall
contain the following information:
A) full and abbreviated name (if available), including brand name, legal form of
medical organization, address (location), as well as phone numbers and email
addresses of the medical organization (if applicable);
B) primary state registration number of record (OGRN) on the state registration of
the medical organization;
C) taxpayer identification number;
D) list of works (services) in accordance with the license for conduction of medical
activity
7. Documents Required by
Roszdravnadzor
A) copies of constituent documents;
B) copies of documents confirming the existence of departments (wards) of
intensive care and resuscitation, and in case of conducting clinical trials of medical
devices involving human subjects belonging to classes 2B and 3 depending on the
potential risk of use:
a copy of the document establishing the number of beds and the structure and
staffing of healthcare organization approved by the head of the medical
organization;
information on the sanitary-epidemiological conclusion (with number and date) on
the conformity to sanitary rules of the premises necessary for performance of
works (services) when performing the medical practice in anesthesiology and
resuscitation;
8. Documents Required by
Roszdravnadzor (cont.)
C) copies of documents confirming the availability of clinical (diagnostic) laboratory,
with an indication of its profile (for medical devices for in vitro diagnostics):
information on the sanitary-epidemiological conclusion (with number and date) on
the conformity with the sanitary rules of the premises necessary for performance of
works (services) when performing the medical activities in laboratory diagnosis,
clinical laboratory diagnosis;
information on the sanitary-epidemiological conclusion (with number and date) on
the possibility of conducting certain types of work with specific types of
microorganisms on each structural unit conducting the work with pathogens of I
and II groups of pathogenicity (if needed)
D) A copy of the document that establishes the procedure for handling confidential
information, approved by the head of the medical organization.
9. Documents Required by
Roszdravnadzor (cont.)
Statement of intent to conduct clinical trials of medical devices shall be signed by
the head of the applicant organization or an authorized person and approved by
stamp of the medical organization.
Roszdravnadzor then verifies the license for conduction of medical activity of the
applicant organization and issues permission to conduct clinical trials of medical
devices, and makes an entry in the list of medical institutions conducting clinical
trials of medical devices.
10. Accreditation of Medical Institutions
by Roszdravnadzor
Sample letter from Roszdravnadzor
confirming the acceptance of the clinic’s
application and its entry into the list of
organizations accredited for performance
of clinical trials of Medical Devices.
11. Before you begin (foreign
Manufacturer)
Copies of Contracts for
conducting the necessary trials
(investigations) containing the
quantity of MDs
Applicant organization
Expert body
1. Contract for conducting
of clinical trials (Tech.,
toxicology etc.)
2. Determining the right
quantity of Medical
Devices being tested
Application
1. Name of the MD, including
equipment, quantity, factory
number, serial number or
lot/batch number,
manufacturing date, shelf life
and/or lifetime
2. Intended use
3. Information about applicant
4. Information about
organizations where the
trials are planned.
Copy of Document that
verifies the authority of
Manufacturer’s
Representative
Presenting of documents
for receiving Permission
to Import of MDs for
State registration to
ROSZDRAVNADZOR
Checking completeness
and composition of
presented data and
documents
Comply
Does Doesn’t
Issuing the
Permission to
Import of MDs for
State registration
Issuing the notice of
refusal in issuing
the Permission to
Import of MDs for
State registration
13. Choosing the medical facility
Ultrasound diagnostics
Address Scope of medical licence
14. Choosing the medical facility: Before
the Clinical Trials
• You should prepare your own Risk analysis and list of analogue devices
•You should present a clinical data on your Medical Device and on analogue devices
(special attention should be paid in case of existing Registration Certificate for the
Medical Device in Russia – this will help you avoid clinical trials on human subjects)
•After these two steps, the medical institution will assess the documentation and
determine if the data presented is enough to state safety and performance of the MD
or if clinical trails on human subjects are necessary.
• After finding the type of Medical Device you need in the scope of the accredited
medical facility, make sure that the facility will be able to perform clinical trials for your
device by contacting them.
