According to the definition provided in clause 1 article 38 of the Federal Law dated November 21, 2011 No.323-FZ “ON THE FUNDAMENTALS OF PUBLIC HEALTH PROTECTION”:
“Medical devices are interpreted as any instruments, appliances, devices, equipment, materials and other articles applied for medical purposes individually or in combination as well as together with other accessories required for application of the said devices by their intended purpose, including special software, and designed by the manufacturer to prevent, diagnose, treat and rehabilitate diseases, monitor status of the human body, conduct medical research, recover, substitute and change the anatomic structure or physiological functions of the organism, prevent or terminate pregnancy, the functional designation of which shall not be implemented via pharmacological, immunological, genetic or metabolic impact on the human body. The medical devices can be recognized as interchangeable if they are comparable in terms of functional designation, quality and technical characteristics and capable replacing each other”.
Medical devices (MD) shall be split into classes depending on the potential risk of their application and into types in accordance with the nomenclature classification of MD; classifications shall be governed by the Order of the Ministry of Healthcare of the Russian Federation dated June 16, 2012 No.4n “On approving nomenclature classification of medical devices”.
The prerequisite for circulation of MD on the territory of RF is its state registration (323-FZ). Pursuant to the Order of the Ministry of Healthcare of the Russian Federation dated October 14, 2013 No.737n “On approving the Administrative Regulation of the Federal Service for Surveillance in Healthcare for provision of the state service on state registration of medical devices”, the function for registration of MD is vested upon the Federal Service for Surveillance in Healthcare (Roszdravnadzor). Both national and foreign-made MDs are subject to state registration.
The rules of state registration of MD are approved by: RF Government Decree dated December 27, 2012 No.1416 (edited on 17.07.2014) “On approving the Rules for state registration of medical devices”, Order of the Ministry of Healthcare of the Russian Federation dated December 21, 2012 No.1353n “On approving the procedure for organization and conduct of expertise of quality, efficacy and safety of medical devices”, Order of the Ministry of Healthcare of the Russian Federation dated June 3, 2015 No.303n “On introducing amendments into the Order of the Ministry of Healthcare of the Russian Federation dated December 21, 2012 No.1353n “On approving the procedure for organization and conduct of expertise of quality, efficacy and safety of medical devices”.
The procedure for carrying out basic research required for registration of MD is specified in article 38 part 323-FZ:
“For the purposes of state registration of medical devices in the manner set by the authorized federal executive authorities, the conformity assessment in the form of technical tests, toxic research, clinical tests and expertise of quality, efficacy and safety of medical devices as well as tests for the purposes of approving the type of measuring instruments (in respect of medical devices attributed to the measuring instruments in the area of state regulation for ensuring uniformity of measurements, the list of which shall be approved by the authorized federal executive authority) shall be conducted”.
The expertise of quality, efficacy and safety shall be conducted in stages:
1) first stage – expertise of application and documents submitted for the purpose of registration to determine feasibility (non-feasibility) of conducting clinical tests of medical devices;
Following the stage 1 expertise results, Roszdravnadzor shall issue a Permit for conducting clinical research.
2) second stage – expertise of completeness and quality of results of the conducted technical and toxicological tests, clinical research as well as tests for the purposes of approving the type of measuring instruments.
Following the stage 2 expertise results, in case of a positive opinion Roszdravnadzor shall take decisions on state registration and shall issue a Registration certificate.
The Order of the Ministry of Healthcare of the Russian Federation dated January 9, 2014 No.2n “On approving the procedure for conducting conformity assessment of medical devices in the form of technical tests, toxicological research, clinical tests for the purposes of state registration of medical devices” provides a characteristics and determines the scope of tests required for registration of medical devices:
Technical tests:
The technical tests of medical devices shall be conducted in the form of tests and (or) data assessment and analysis (hereinafter tests, data assessment and analysis respectively) for verification of quality and safety of medical devices when using it by its intended purpose as stipulated in the manufacturer’s documentation.
The technical tests in the form of assessment and data analysis shall be conducted only in respect of the medical devices, for assembly (commissioning) of which it is required to obtain permits (licenses), establish special conditions, to build separate capital facilities and train specialists and in individual cases – to visit the site of the prospective manufacture of the medical device).
The technical tests of medical devices for in vitro diagnostics (devices, equipment, panel of reagents, reagents, agents, test systems, control materials, calibrators and nutrient media) shall be conducted for the purpose of verification of quality and safety of medical devices for in vitro diagnostics when using it by its intended purpose as stipulated in the manufacturer’s documentation.
The technical tests of medical devices for in vitro diagnostics in the form of closed analytical systems conducted in respect of the medical device together with the accessories, panels of reagents and calibrators required for application of the medical device by its intended purpose can be carried out within the framework of a single technical test.
The technical tests of medical devices for in vitro diagnostics shall be based upon:
а) analysis of data from scientific & technical literature attributed to safety, efficacy, functionality as well as to the application of the medical device for in vitro diagnostics as prescribed by the regulatory documentation, technical and maintenance documentation of the manufacturer;
- b) analysis of results of the conducted tests of the medical device for in vitro diagnostics.
- Toxicological research
The toxicological research of the medical device shall be conducted in respect of the device coming in contact with the human body when using it by its intended purpose as stipulated in the manufacturer’s documentation:
а) medical device and (or) accessories to the medical device coming in contact with the human body surface;
- b) medical device temporarily injected into the human body outwardly;
- c) medical device implanted into the human body.
The toxicological research of the medical device shall be conducted for the purpose of assessing a biological effect of the medical device on a human body and include verification of the following parameters:
а) physical & chemical;
- b) sanitary & chemical;
- c) biological in the context of in vitro and in vivo.
- Clinical research
The clinical tests of medical devices shall be conducted in the form of research (hereinafter – analysis and assessment of clinical data) and in the form of tests, involving human participants (hereinafter – tests with human participation), for the purpose of assessing safety and efficacy of the medical device.
The tests of medical devices involving human participants shall be conducted in the following cases:
а) new type of a medical device;
- b) application of new complex and (or) unique and (or) special methods of prevention, diagnostics and treatment of diseases and states as well as application of new complex medical technologies;
- c) if when conducting analysis and assessment of clinical data the efficacy and safety of the medical device is not verified.
In other cases clinical tests of medical devices shall be conducted in the form of analysis and assessment of clinical data.
The clinical tests of medical devices for in vitro diagnostics shall be conducted in a laboratory with the application of patient biomaterial samples selected during a medical treatment and diagnostics process (hereinafter – clinical & laboratory tests) for verification of functional properties and(or) efficacy of the medical device when using it by its intended purpose as stipulated in the manufacturer’s documentation.
The clinical & laboratory tests of medical devices for in vitro diagnostics of new infectious diseases or rarely occurring infectious diseases with natural foci shall be conducted in a laboratory with the application of museum test strains from state, national, research and other collections of pathogenic microorganisms.
The clinical & laboratory tests of medical devices for in vitro diagnostics in the form of analytical systems conducted in respect of the medical device together with the accessories, panels of reagents and calibrators required for application of the medical device by its intended purpose can be carried out within the scope of a single test.
The state registration of MD shall be performed on the basis of the results of technical and toxicological tests and clinical research. MD registration process starts with the preparation of a registration dossier that represents a set of documents submitted for state registration.
Our company shall provide a full range of service for MD registration starting with the stage of formation of a registration dossier and ending with the stage of obtaining a Registration certificate.
A registration certificate shall be issued in case of a positive opinion following the expertise results for an unlimited term and shall be valid in case of preserving all information on MD stated therein intact.
A recipe for success is a sound and responsible approach towards the development of necessary documents as well as the selection of testing centers.
Our company aims to facilitate and accelerate, as much as possible, the registration procedure for our clients.
We will assist in:
Developing a program of research and preparing: a regulatory instrument (document) (RI), technical documentation (technical specifications, technical regulations), maintenance documentation (operating manual, operating instructions and application instructions), label;
Organizing and performing monitoring of technical and toxicological tests as well as planning and conducting clinical research of MD, including obtaining a permit for clinical research with the authorized authorities;
Preparing a package of documents for registration according to the applicable requirements, executing an application for registration;
Submitting documents to Roszdravnadzor;
Conducting monitoring of expertise of quality, efficacy and safety of MD;
Supporting the documentation process at Roszdravnadzor with the purpose of obtaining a Registration certificate for MD and obtaining a Registration certificate.
References to regulatory documents:
Federal Law dated November 21, 2011 No.323-FZ “ON THE FUNDAMENTALS OF PUBLIC HEALTH PROTECTION IN THE RUSSIAN FEDERATION”
Order of the Ministry of Healthcare of the Russian Federation dated June 16, 2012 No.4n “On approving nomenclature classification of medical devices”.
Order of the Ministry of Healthcare of the Russian Federation dated November 14, 2013 No.737n “On approving the Administrative Regulations of the Federal Service for Surveillance in Healthcare for provision of the state service on state registration of medical devices”
RF Government Decree dated December 27, 2012 No.1416 (edited on 17.07.2014) “On approving the Rules for state registration of medical devices”.
Order of the Ministry of Healthcare of the Russian Federation dated December 21, 2012 No.1353n “On approving the procedure for organization and conduct of expertise of quality, efficacy and safety of medical devices”.
Order of the Ministry of Healthcare of the Russian Federation dated June 3, 2015 No.303n “On introducing amendments into the order of the Ministry of Healthcare of the Russian Federation dated December 21, 2012 No.1353n “On approving the Procedure for organization and conduct of expertise of quality, efficacy and safety of medical devices”.
Order of the Ministry of Healthcare of the Russian Federation dated January 9, 2014 No.2n “On approving the procedure for conducting conformity assessment of medical devices in the form of technical tests, toxicological research, clinical tests for the purposes of state registration of medical devices”.