Questions and answers
What products belong to the medical?
Preparation of photographs of medical devices for registration
Requirements for the content of the manufacturer’s operational documentation for the medical product
The operational documentation of the manufacturer (producer) for the medical product (hereinafter referred to as the operational documentation) provided by the medical product manufacturer (producer) or by the authorized representative of the medical product manufacturer (producer) as part of the Common Technical Document for the medical product shall contain:
- name of a medical product;
- concerning the medical product manufacturer (producer) full and (if available) abbreviated name, including the company name, legal entity form, place of business address or last name, first name and (if available) patronymic, details of the identity document, residential address of the self-employed entrepreneur, as well as phone numbers and (if available) the e-mail of the legal entity or self-employed entrepreneur;
concerning the authorized representative of the medical product manufacturer (producer), the full and (if available) abbreviated name, including the company name, legal entity form, address (location), telephone numbers and (if available) the e-mail of the legal entity;
- the purpose of the medical product with specifying the potential consumer (for example, it is a health professional);
- functional specifications and purpose of the medical product;
- risks of using the medical product, contraindications, expected and predictable side effects connected with the medical product intended application;
- technical specifications of the medical product;
- description of accessories, medical products or products which are not medical, but intended for use in combination with a medical product (if any);
- information on the medicine for human use existence in the medical product, animal materials and (or) human origin materials;
- information on the installation procedure, assembling, adjustment, calibration and other actions necessary to put the medical product into operation;
- requirements for locations wherein the medical product installation (mounting) is assumed to be, as well as the requirements for the training or qualification of persons who install (mount) the medical product (if any);
- information for verifying the correctness of the installation (mounting) of the medical product and its readiness for safe operation, including:
a) maintenance and service frequency, including cleaning and disinfection of the medical product;
b) provided by the medical product manufacturer (producer) list of information, keys, access passwords, programs required for installation, commissioning, operation and maintenance of the medical product;
c) list of consumable products (components, reagents), as well as the procedure for their use and replacement;
d) need for calibration for ensuring appropriate and safe operation of the medical product during its lifetime;
e) methods of risks reduction associated with the installation, calibration or maintenance of medical products;
f) information on mounting, adjustment, setting up, calibration and other actions necessary for putting the medical product into operation and its proper operation (application);
g) information on the list of the main characteristics of the operation (application) of the medical product, transportation and storage conditions (for example, temperature and humidity, lighting and other characteristics);
h) the list of national standards applied by the manufacturer (producer) of the medical product.
- information on the sterile condition of the medical product, its sterilization method and the plan of action in case of the sterile package violation (if the medical product is delivered sterile) or, if the medical product is supplied non-sterile, the instruction on need of its sterilization before use;
- information on the medical product treatment procedure for its repeated use, including cleaning, disinfection, packaging and, if necessary, the resterilization method (if the medical product is non-disposable), as well as the criteria for the medical product unfitness for use;
- the information necessary for medical products identification in order to obtain a safe combination, and information on known joint use restrictions of medical products (for medical products intended for use with other medical products and (or) accessories);
- information on the nature, type, and also (if necessary) on the intensity and distribution of radiation (electromagnetic, ionizing, other) of the medical product and information on ways of consumers and third parties protection from unintentional radiation during the medical product operation (if the medical product the dangerous or potentially dangerous radiation level when used as intended);
- information on precautionary measures taken in the event of:
a) malfunctions of the medical product, failure in his work or deviations in functioning that may affect the medical product safety, including malfunctions determined by outward signs;
b) external factors impact on the medical product functioning connected with the medical product use in combination with other medical products and (or) equipment, or such predictable factors as external electromagnetic fields, electrostatic discharges, radiation (electromagnetic, ionizing, other), atmospheric pressure and its differences, humidity and air temperature;
c) risk of electromagnetic interference created by the medical product for other medical products, equipment and communication equipment during the carrying out and evaluating the results of diagnostics, treatment, or when used for its intended purpose (for example, electromagnetic radiation from the medical product affecting other equipment);
- prevention and (or) precautions taken by the consumer when using a medical product containing medicinal product for human use, animal material and (or) human origin material, materials which are carcinogenic, mutagenic or toxic, the possible discharge or washout of which leads to sensitization, allergic reaction or negatively affects reproductive function;
- prevention and (or) precautions taken by the consumer when disposing of the medical product, accessories and consumable materials used with it (if any), including information on the infectious, microbial, environmental or physical hazard of the medical product;
- information on circumstances under which the consumer should consult a healthcare professional;
- information on the initial release or the latest revision of the operational documentation;
- procedure and conditions for the disposal or destruction of the medical product.
The operational documentation of a medical product for in vitro diagnostics
The operational documentation of a medical product for in vitro diagnostics, in addition to the information specified for other medical device, shall contain:
- information on the medical product intended use:
a) description of the target analyte with a qualitative, semi-quantitative or quantitative indication;
b) specific disorder, condition or risk factor for detection, definition or differentiation of which the medical product is intended
c) test portion type;
- information on the intended for clinical laboratory diagnostics purpose;
- description of the testing procedure with use of the medical product, description of reagents, calibrators and control materials;
- the list of materials and special materials that are required for testing (analysis), but are not included in the scope of delivery of the medical product;
- information for the medical products identification for the purpose of safe combination obtaining and (or) information on known restrictions on the medical products joint use for their intended use (for medical products intended for use in combination with other medical products, including medical products for in-vitro diagnostics);
- information on the stability characteristics of the medical product (for example, storage conditions, in-use stability after the opening of the primary package);
- information for the medical product consumers on precautionary measures taken when necessary, as well as on precautions and (or) measures taken concerning potentially infectious material contained in the medical product;
- information on the purpose of the single-use medical product;
- information on the necessary treatment of the medical product for the purpose of its repeated use, including cleaning, disinfection, packaging and, if necessary, the method of repeated sterilization (if the medical product is intended for repeated use);
- information on the conditions necessary for the collecting, processing and preparation of samples, data on the stability of the analyzed samples, including conditions and storage period, transport conditions, restrictions on freezing (defrosting) cycles;
- information on the preparing for intended use, for the operation of the medical product;
- information on the values traceability set for calibrators or control materials, which is provided by available reference measurement techniques and (or) standards;
- description of testing procedure, including calculation and interpretation of test results and, if necessary, information on the futility of carrying out confirmatory tests;
- analytical performance characteristics: sensitivity, specificity, correctness, repeatability, reproducibility, detection limit and range of measurement, including information on the effect of known interference, on limitations of the method and information on the use of available reference materials and analysis methods;
- clinical efficacy characteristics: diagnostic sensitivity and diagnostic specificity;
- biological reference interval of use of the medical product;
- information on interfering substances or on limitations associated with the sample, which may affect the result of the study;
- prevention and (or) special precautions for the safe disposal of a medical product and its accessories, which should describe:
a) infectious or microbial risks, including the possibility of infection of consumables with infectious agents of human origin;
b) environmental risks connected with potentially hazardous materials and substances.
Is it necessary to obtain permission from Roszdravnadzor to import medical devices for scientific purposes?
Scientific (research) activity is regulated by the Federal Law of 08.23.1996 No. 127-FZ “On Science and State Scientific and Technical Policy”.
Products intended by the manufacturer for scientific research only, on the basis of the provisions of Federal Law No. 323-FZ “On the Basics of Protecting Citizens’ Health in the Russian Federation”, are not medical and are not subject to state registration as medical devices.
Thus, the issues of import and circulation of products for scientific research on the territory of the Russian Federation are not within the competence of Roszdravnadzor.
What registration certificates are subject to replacement?
The list of medical devices refer to measuring instruments in the field of state regulation for assurance of measurements uniformity in respect of which type approval tests to be performed
The main differences between the registration process under the EAEU rules and the national rules of the Russian Federation
The main differences between the registration process under the EAEU rules and the national rules of the Russian Federation are as follows:
– higher requirements for the registration dossier,
– departure of inspectors in the process of registration for production,
– multicenter clinical trials of products of risk class 2b and 3 on patients,
– in the Registration Certificate it will be possible to indicate from two to five countries of recognition at the applicant’s choice (Russian Federation, Republic of Armenia, Belarus, Republic of Kazakhstan, Kyrgyz Republic),
– additional state duty for the approval of the examination,
– The process of approving expert reviews by experts from other countries of recognition.
Is it possible to include in one registration certificate several modifications of a medical device related to one type of medical device?
The inclusion in one registration certificate of several modifications of a medical device related to one type of medical device in accordance with the nomenclature of medical devices used in the Eurasian Economic Union is possible provided that these modifications meet all of the following criteria:
a) the production of modifications to the medical device is carried out by one manufacturer of the medical device according to one technical documentation;
b) modifications to a medical device belong to one class of potential risk of use;
c) the presence and (or) quantitative content in a biological sample of the same clinically (diagnostically) significant analyte (s) (for medical devices for in vitro diagnostics);
d) modifications to a medical device have various configurations that do not affect the principle of operation and functionality, which allows for the expansion or specialization of their use for medical purposes (as applicable);
e) modifications to a medical device have various technical parameters (for example, radiation wavelength, light field size, resolution, etc.) that do not affect the operating principle and functionality (as applicable);
f) modifications to a medical device form a series of sizes (for example, have different sizes (overall, linear, volume, etc.), shape, color coding, etc.) or are a performance group of a medical device (for example, a stationary mobile device ( appliance, system, complex, etc.) with wall and (or) floor mount, etc.) (as applicable). At the same time, under the execution group of a medical device are understood products in respect of which one group drawing of parts and (or) one group specification has been made.
Is an import authorization required for medical device accessories?
In accordance with paragraph 1 of Art. 38 of the Federal Law of November 21, 2011 No. 323-FZ “On the Basics of Protecting the Health of Citizens in the Russian Federation”, medical devices are any instruments, apparatus, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, and also, together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of monitoring the state of the human body, conducting medical research, restoring, replacing, changing the anatomical structure or physiological functions of the body, preventing or terminating pregnancy, the functional purpose of which is not realized through pharmacological, immunological, genetic or metabolic effects on the human body.
In accordance with Order No. 7n of the Ministry of Health of the Russian Federation dated June 15, 2012 “On Approving the Procedure for Importing Medical Devices into the Russian Federation for State Registration”, Roszdravnadzor issues permits for importing medical devices for state registration.
According to GOST 31508-2012 “Medical devices. Classification according to potential risk of use. General requirements “belonging to a medical device – items that are not independently medical devices and, for their intended purpose, are used in conjunction with medical devices or in their composition so that medical devices can be used in accordance with their intended purpose.
Therefore, an import authorization for medical device accessories is not required.
Will the numbers and dates of issued registration certificates be preserved during the replacement?
Yes, when replacing registration certificates, the number and date specified in the previously issued certificate is retained.
How long does it take to replace a registration certificate from the moment of filing an application?
Decree of the Government of the Russian Federation of the Government of the Russian Federation of December 27, 2012 No. 1416 did not establish deadlines for the replacement of registration certificates. Applications for replacement are considered within the time period established for consideration of applications – 30 days from the date of receipt of the application to Roszdravnadzor.
Classification of medical devices
Medical devices are divided into classes depending on the potential risk of their use and types in accordance with the nomenclature classification of medical devices. The nomenclature classification of medical devices is approved by the authorized federal executive body.
When classifying medical devices, each medical device can be assigned to only one class:
Class 1 – medical devices with a low degree of risk;
class 2a – medical devices with an average degree of risk;
class 2b – medical devices with a high degree of risk;
class 3 – medical devices with a high degree of risk.
When classifying medical devices, their functional purpose and conditions of use, as well as the following criteria, are taken into account:
the duration of the use of medical devices;
invasiveness of medical devices;
the presence of contact of medical devices with the human body or its relationship with it;
the method of introducing medical devices into the human body (through anatomical cavities or surgically);
the use of medical devices for vital organs and systems (heart, central circulatory system, central nervous system);
use of energy sources.
What is the difference between a certificate of conformity and a declaration of conformity and what is the procedure for document execution?
The certificate of conformity and the declaration of conformity are two forms of mandatory certification of products for compliance with national standards or other regulatory documents.
The documents are necessary for customs clearance and medical products distribution in the Russian Federation. The binding obligation of declaration of conformity and the certificate of conformity is determined for specific types of goods in accordance with Government Decree No. 982 dated 01.12.2009. The decree is called “On approval of a consolidated list of products subject to mandatory certification and a consolidated list of products, conformity of which is carried out in the form of adopting a declaration of conformity “.
The document is relevant as amended on February 21, 2018 in the version that took effect on December 27, 2018. To determine the need for a declaration or certificate, originally we are looking for the product of interest in the section “A single list of products, confirmation of compliance of which is carried out in the form of acceptance of a declaration of conformity” and if we do not find it there, then we look in the section “A consolidated list of products subject to mandatory certification”. The presence of the product in a particular section determines the need for the first or second document. Some differences between the certificate and the declaration:
Only a Russian taxpayer can execute a declaration of conformity for products in the Russian Federation. At the same time, a foreign manufacturer can obtain a certificate of conformity for their products in Russia.
Provided that the certificate was obtained successfully, the manufacturer should share the responsibility for the information included in the document and for product safety with the certification body, where the conformity document was issued.
While upon receipt of the declaration of conformity, all responsibility lies on the manufacturer of the product (or another person performing the declaring of goods).
Provided that the certificate was obtained successfully, the document is issued on a typographic form. The declaration of conformity is filled out on a plain sheet of paper. The lack of medical products in both lists suggests that it is not subject to mandatory declaration or mandatory certification. In this case, for customs clearance, it is better to draw up a letter of refusal from the certification body, which will contain information about the optional declaration and certification. For advertising or other similar purposes, you can issue a voluntary certificate of conformity.
What is included in our estimated registration cost?
I. Formation of the “Registration dossier”:
– preparation of an application for registration of a medical device;
– preparation of an application for the import of a medical device for the purpose of state registration;
– the formation and submission of a set of documents to Roszdravnadzor in order to obtain permission to import the product;
– development of information on regulatory documentation;
– adjustment of technical and operational documentation;
– Accompanying the translation of manufacturer documentation;
– verification of the accuracy of execution of a power of attorney issued on behalf of the manufacturer to an authorized representative and the main package of documents of the manufacturer;
– organization and support of toxicological studies (tests) of a medical device (if necessary);
– organization and support of technical testing of a medical device;
– organization and support of electromagnetic compatibility tests (if necessary).
II. Submission of the “Registration dossier” to the Federal Service.
III. Maintenance examination of the quality, effectiveness and safety of a medical device (stage I examination)
– in case of a request from Roszdravnadzor about the need to provide additional documents or information, issue an act of eliminating comments, collect and submit documents to the Federal Service;
– preparation of the necessary cover letters, support for the translation of additional documents;
– upon receipt of a negative expert opinion, draw up an Act to eliminate comments, eliminate (if the Manufacturer and the Customer provide information and necessary documents) these comments, make changes to the documentation (as agreed with the Customer), submit one Registration dossier to Roszdravnadzor again.
IV. Clinical trial support
– organization and support of comparative tests when the Customer provides information about the analogue of the registered product;
– organization and support of clinical trials of a medical device (only in the form of analysis and evaluation of clinical data).
V. Support for the examination of the quality, effectiveness and safety of a medical device (stage II examination)
– Elimination of comments when requesting additional information by Roszdravnadzor in case of providing the necessary information and documents by the Manufacturer and / or Customer;
– Obtaining a Registration Certificate for a medical device in Roszdravnadzor and transferring it to the Customer.
What is not included in the estimated cost of registration?
– development of technical conditions, technical and operational documentation,
– development of a risk management file, preparation of a clinical assessment report,
– translation and notarization of documents of a foreign manufacturer,
– payment of state fees for the issuance of a registration certificate and for the examination of efficiency, quality and safety,
– payment for all types of tests of a medical device,
– payment of customs duties when importing a medical device for testing.
Please note that to assess the cost of technical tests, the laboratory requires the provision of a technical file and a list of products for registration. If you need to develop documents, contact us and we will be happy to help you with this.