Initial Registration Process of Medical Products from Abroad in the Russian Federation blog DeviceMaster GmbH

Initial Registration Process of Medical Products from Abroad in the Russian Federation

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The Russian Federation is the world’s largest country in terms of land and has an emerging market to match, although it doesn’t have as much foreign investment as many other emerging markets. Due to the complex registration process and strict regulatory supervision of medical products worldwide, especially in Russian Federation (RF), medical product manufacturer shall be able to understand the local registration process and regulatory affairs exactly, so that a market success of the product can be achieved. This document aims to give a brief introduction to the initial registration process of the medical product (Class II & III) from abroad in RF.

Background

In the Russian Federation all medical devices for diagnostic or therapeutic purposes must be registered in Moscow, at the central department of the Federal Service on Surveillance in Healthcare and Social Development (ROSZDRAVNADZOR). It is a federal executive body responsible for control and supervision of the Healthcare system.

The Federal Service for Surveillance in Healthcare  (RZN) is subordinate to the Ministry of Health of the Russian Federation and guided by the RF Constitution, federal constitutional laws, federal laws, acts of the president of the RF and state government, international agreements, acts of the Ministry of Health of the Russian Federation and the regulations stated in resolution no. 323 dated 30.06. 2004 “On the Federal Service for Surveillance in Healthcare”.

Medical Device Classification in Russia

The Russian classification system is similar but not identical to the European system. Identification of equivalent devices already marketed in RF is required. Classifications are confirmed using RZN Order No. 735 and GOST 51609-2000. Medical devices and IVDs in Russia are classified based on potential risk, with increasing risk assigned to Classes I, IIa, IIb, and III. Additionally, Russia uses a nomenclature code system, dividing medical devices into types, and the device type is encoded in a six-digit numeric code. This system is comparable to the internationally recognized Global Medical Device Nomenclature (GMDN) code system.

The Russian nomenclature code is listed on the Registration Certificate (RC), and may be used for tenders and government procurement. Companies can search RZN’s online database (in Russian) for their nomenclature code. However, the database is incomplete and may not include all products. In case that a nomenclature code cannot be identified, a formal inquiry must be submitted to RZN for their opinion.

„De Novo“ vs „Predicate Device“ Registration

Based on the decision of the Eurasian Economic Commission’s Board resolution of 24.07.2018 N 123 „On criteria for inclusion in one registration card of several modifications of medical products pertaining to one type of medical product in accordance with the one used in the Eurasian Economic Union“ the Eurasian Economic Commission has approved the criteria for including several modifications of medical products in one registration card.

The inclusion in one registration card of several modifications of medical products relating to one type of medical product in accordance with the range of medical products used in the Eurasian Economic Union is possible, provided these modifications meet all the following criteria:

  • Modifications of medical products are carried out by one manufacturer of medical products on one technical documentation;
  • Modifications of medical products belong to one class of potential use risk;
  • The presence and/or quantitative content in the biological sample of the same clinically (diagnostic) significant analite (analyta) (for medical products for in vitro diagnosis);
  • Modifications of medical products have different sets, which do not affect the principle of work and functional purpose, which allows to ensure the expansion or specialization of their use for medical purposes (by applicability);
  • Modifications of medical products have different technical parameters (e.g. radiation wavelength, light field size, permitting ability, etc.) that do not affect the principle of work and functional purpose (applicability);
  • Modifications of medical products form a size-size range (e.g. have different sizes (size, linear, voluminous, etc.), shape, colour coding, etc.) or are a performance group of a medical product (e.g. stationary mobile device (device, system, complex, etc.) with wall and/or floor mount, etc.) (applicability). [5]

Registration Process

  • State registration of medical device is a state procedure to ensure that only quality and safe medical devices are introduced into the Russian market.
  • Article 38, paragraph 4, of the Federal Law no. 323 dated 21.11.2011 “On Fundamentals of Healthcare of the Russian Federation Citizens” establishes that medical devices registered by an authorized federal executive body in accordance with the procedure, set by the government of the RF are allowed for circulation on the territory of the RF.
  • The procedure of the state registration is approved by the resolution of the government of the RF no. 1416 dated 12.08.2014 “Approval of regulation of the State Registration of Medical Devices” and the administrative regulation of the RZN in Terms of Provision of the State Service of Registration of Medical Devices approved by the Order of the Ministry of Health of the RF no. 737 dated 14.10.2013.
  • The following flow-chart describes the overall initial registration process for medical products in RF.
State registration process of medical devices in Russian Federation blog DeviceMaster GmbH

 

Class I applications bypass Stage I and go straight to the Stage II review.

  • The examination of the quality, effectiveness and safety of medical products is carried out by the expert agency in stages (provided for 2 stages) in accordance with the order approved by the Ministry of Health of the Russian Federation.
  • Phase I is reviewing the registration application and documents to determine whether to conduct clinical trials of a medical product.
  • Phase II is undergoing an examination of the completeness and results of technical tests, toxicology tests, clinical trials, and tests for approval of the type of measurement sourness (for medical products, related to the means of measurements in the sphere of state regulation of the unity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation).
  • It is now possible, as part of the examination of the quality, effectiveness and safety of medical products for the purposes of state registration at any stage of the examination, to request the missing materials and information from applicants.
  • After the first stage of the examination, it is determined whether it is possible/impossible to conduct clinical trials of a medical product or the impossibility of the state registration of a medical product. Clinical trials of the medical product are carried out in medical organizations certified by RZN based on permission to conduct clinical trials issued also by RZN.
  • At the end of the clinical trials of the medical product, the applicant submits to RZN an application for the resumption of the state registration of the medical product and the results of the clinical trials of the medical product.
  • In the second phase of the examination of the quality, effectiveness and safety of medical products, the expert organization conducts an examination, RZN inspects completeness and results of the tests and studies.
  • The reason for the decision to refuse the state registration of medical products is to obtain a report from the expert institution indicating that the quality and/or safety of the registered medical product are not confirmed by the data obtained, and/or that the risk of harm to the health of citizens and health care workers due to the use of medical products exceeds the effectiveness of its use.

Compliance with Terms

Timeframe: The registration process ranges from 8 months for Class I devices to 16 months for Class III devices.

The state registration of medical products is carried out by RZN within 50 working days of the decision to start the state registration of medical products.

Clinical trials of medical products are not included within 50 days.

Within 1 working day after the decision on the state registration of medical products, RZN introduces data on registered medical products to the State Register of Medical Products and Organizations (individual entrepreneurs) producing and manufacturing medical products.

Documentation to File

The following documents are required for the registration process in the RF [2]:

  1. Registration application form
  2. Power of attorney for Authorized Manufacturer’s Representative (The original with Apostille stamp is required)
  3. ISO 9001/13485 (A certified copy with Apostille stamp is required) CE certificate, 93/42/EEC (A certified copy with Apostille stamp is required) certificate/declaration of conformity (98/79/EC for IVD)
  4. Technical documentation
  5. User manual
  6. Photos of medical device minimum 18 cm x 24 cm (general and with components of medical device essential for the user purpose
  7. Output documentation of technologic tests
  8. Output documentation of toxicologic tests (in case medical device contacts human body)
  9. Output documentation of metrological tests (in case medical device is provided with the tools of weight or measure)
  10. List of documents

An additional document might be required for every single case.

Preferred Form of Documentation

The performing of medical device registration is possible both in paper form and in electronic form. The documents in paper form are to be submitted to ROSZDRAVNADZOR on following address:

Federal service for Surveillance in Healthcare,

Slavyanskaya Square 4, bld. 1,

Moscow, 109074.

To file the documents for state registration of medical device in electronic form, applicants need to be registered on the web-site: https://esia.gosuslugi.ru

For more information see following contacts:

Information service: (495) 698-45-38, (495) 578-02-30

E-mail: info@roszdravnadzor.ru

Press office: Tel /fax (495) 624-80-90

Specific Current Requirements on the Registration Application Documents

Russia Authorized Representative

According to Resolution 1416, manufacturers without a physical location in Russia must appoint an Authorized Representative (AR). The AR is responsible for the device registration and acts as a liaison between the manufacturer and ROSZDRAVNADZOR -Federal Service for Surveillance in Healthcare (RZN).

Product Testing Requirements

Medical device registration in Russian Federation is based on product testing that must be performed in RF.

Test results obtained in other markets are typically not accepted by RZN

Quality, safety and efficacy testing of medical device from overseas applicant is carried out by Authorized Expertise Centers in RF certified by RZN. Results of these tests are a crucial component of the registration application.

Registration Dossier Preparation and Submission

Once product test results are finalized, the registration dossier can be prepared and submitted to RZN for review. Russian regulators may require proof of registration in the applicants home market. RZN does not recognize CE Marking, US FDA 510(k) clearance or any other registration from a foreign regulator. All documents in the registration dossier must be submitted in Russian. RZN may require additional testing upon review of your registration dossier (more often for Class IIb and III devices)

Declaration of Conformity Certification

Overseas applicants must apply for declaration of conformity certification (formerly known as GOST-R certification) after receiving the registration certificate. The model of the declaration of conformity GOST R has been approved and introduced by the Federal Agency for Technical Regulation and Metrology with resolution no. 12 of 17.03.1998 and subsequent amendments, Annex G.

 

Written by Olena Motsak  (Regulatory Expert from DeviceMaster GmbH)
Date: 06.28.2019

Links

[1] https://melegal.ru/legal_information/analytics/267/

[2] www.roszdravnadzor.ru/medproducts/registration/

Normative References

[3] The registration of medical devices in Russia is regulated by the resolution of the Government of the Russian Federation No. 1416 of 27/12/2012.

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