Clinical trials of medical devices

Any medical device must undergo the process of state registration before it can be marketed. The preparation for registration will involve several checks of the medical device involved, including its clinical trials. Medalis can arrange for clinical trials at your request.

What are clinical trials of medical devices?

A clinical trial is an expert evaluation of products and equipment designed for medical applications. Performance of clinical trials is mandated by Decree No. 1416 of the Government of the Russian Federation dated December 27, 2012. The procedure for clinical trials is established by Order No. 2n of the Ministry of Health dated January 09, 2014. Only those accredited laboratories that specialize in the area of application and use of the medical device (MD) subject to state registration are eligible to conduct clinical trials.

Why and when clinical trials are conducted

Clinical trials of medical devices are conducted prior to the submission of a registration dossier to the Federal Service for Supervision of Healthcare (Roszdravnadzor) for the purpose of obtaining state registration. Clinical assessment of medical devices is undertaken in order to:

• Assess safety of use of the product;
• Identify the parameters of therapeutic/diagnostic/preventive effects of the use of the product;
• Assess whether the medical device meets national standards, related documentation submitted by the applicant, and its intended use for medical purposes.

Highly hazardous medical devices are to be tested upon a prior authorization by Roszdravnadzor.

Forms of clinical trials

According to regulations of the Ministry of Health, medical devices are tested in the following formats:

• A study and review of related documents and reports on any previous (technical, operational, toxicological) assessments; measurement of comparative performance against analogues; review of publications on practical application of the technology in other countries.
• Actual laboratory testing that involves volunteer subjects (patients).

Clinical trials on volunteer subjects are carried out when:

• A brand new medical technology is to be launched;
• Modified versions of an existing product are to be launched;
• Innovative methods of therapy, prophylaxis or diagnosis are developed on the basis of those already in use.

Trials on human subjects are expected in cases where the safety and efficacy of a medical device has not been confirmed by the analytical portion of clinical trial.

Package of documents

The following documents are to be provided to a medical facility:

• An application for performance of clinical trials;
• Sample(s) of the medical device involved (except for medical devices whose installation/commissioning requires a permit/license, any special environment, construction of separate permanent facilities, and additional training of specialists, or, in some cases, visiting the facility where the medical device is located and/or permitted for use under laws of the destination country);
• A clinical trial permit issued by Roszdravnadzor;
• An assessment report on technical testing of the medical device, including documents supporting the results of technical testing;
• An opinion based on the toxicity study results of the medical device, including documents supporting the results of the toxicity study (for medical devices that involve contact with the human body);
• Results of tests of measuring instrument pattern approval (for medical devices classified as measuring tools in the sphere of state regulation to ensure the uniformity of measurements, whose list is approved by the Ministry of Health of the Russian Federation);
• Information on regulatory documentation of the medical device, listing national/international standards with which it is compliant (when used by the manufacturer);
• Manufacturer’s technical and operational documentation of the medical device;
• General view photographs of the medical device together with accessories that are necessary for its intended use (18 x 24 cm or larger);
• Documents/materials with data on the clinical use of the medical device, including outside the Russian Federation, such as, without limitation, reviews, scientific study reports, publications, presentations, risk of use analyses or methods of use, if any.

For in vitro diagnostics (IVD) medical devices, the following documents are to be provided:

• An application for clinical trials of an IVD medical device;
• Sample(s) of the IVD medical device along with accessories (equipment, reagent kits, calibrators, reactants, testing systems, controls, calibrators, growth media) that are necessary for its use as intended;
• An assessment report on technical testing of the IVD medical device to certify the performance of the IVD medical device along with its accessories (equipment, reagent kits, calibrators, reactants, testing systems, controls, calibrators, growth media) when used as intended;
• Operational documentation for the IVD medical device with accessories (equipment, reagent kits, calibrators, reactants, testing systems, controls, calibrators, growth media) that are necessary for its intended use, if necessary;
• Documents/materials with a review of data on the use of the IVD medical device, if any;
• Results of tests for measuring instrument pattern approval (for IVD medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, whose list is approved by the Ministry of Health of the Russian Federation).

Pricing

Pricing

Содержание	Pricing on national system	Pricing EAUE
Оценка информации, предоставленной Доверителем о клиническом использовании медицинского изделия. Составление и согласование с клинической базой программы клинических исследований изделия, а также проведение клинических испытаний в соответствии с положениями нормативно правовых актов, корректировка клинических данных по клинической применимости изделия и предоставление заявления и пакета документов в регистрирующий орган, для проведения второго этапа экспертизы.	от 350 т.р.	от 400 т.р.

The cost depends on the application of the medical device in question, its risk class, availability of clinical data, availability of registered analogues, intended purpose, and form of testing. The exact price will be calculated based upon a thorough review of the registration dossier.

Сроки КИ

The duration of clinical trials depends on their format. Clinical trials in the form of analysis and assessment will take about one month. For clinical trials with human subjects, the duration will depend on the type of medical device involved and may take from three months up to several years. Clinical and laboratory (in vitro) testing may take 1.5 to 4 months.

Clinical trials in Moscow

Our team members have extensive experience in arranging clinical trials of medical devices produced by both Russian and foreign manufacturers who seek to enter the markets of Russia and EAEU.

As we partner with the best medical facilities listed in the registry of organizations authorized to conduct clinical trials, we are able to have clinical trials completed promptly and at the best possible price.