Choosing the right facility for clinical trials

in Russia

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

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.

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.

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.

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

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;

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.

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.

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.

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

Choosing the medical facility

Medical facility

Roszrdavnadzor’s website:

Choosing the medical facility

Ultrasound diagnostics

Address Scope of medical licence

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.

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