Certification of Medical Devices in Russia

Certification of Medical Devices in Russia

Certification of medical devices is a way to confirm the compliance of devices with the requirements of technical regulations, standardization documents, or contract terms.

Certification is a type of assessing the compliance of medical devices with the requirements of regulatory documents. Medical equipment and medical products are very complex in terms of assessing their compliance since they can pose both direct and indirect threats to human life and health.

This results in increased attention from supervisory authorities, and is also the reason for the existing complex and multi-stage assessment procedures and their diversity.

Certification of medical devices in Russia is not the only type of assessment of their compliance!

Let us determine what authorization documents are required for a medical device (MD) to bring it to the Russian market. To avoid additional costs for correction and save time, it is important to understand all the nuances of the current legislation.

To understand what type of compliance assessment is applicable for medical devices, one should understand their purpose and scope of application. In Russia, medical devices are divided into medical products and medical equipment.

Medical products (MP) are the products intended for use in medical practice. These are appliances, dressings and sutures, products made of polymer, rubber, and other materials that are used for medical purposes separately or in combination for:

  • prevention, diagnosis, treatment of diseases, rehabilitation, medical procedures, medical research, replacement or modification of parts of tissues, organs and the human body, restoration or compensation of impaired or lost physiological functions, as well as conception control;
  • affecting the human body in such a way that their functional purpose is not realized through chemical, pharmacological, immunological, or metabolic interaction with the human body.

Medical equipment (ME) is the apparatus, gadgets, instruments, devices, complexes, program-controlled systems, equipment intended for use on humans for: research, diagnosis, observation, treatment, prevention, alleviation of disease, compensation for injury or disability and maintenance of physiological functions.

In sum, medical devices in Russia are any instruments, apparatus, tools, devices, materials, or other products, used individually or in combination with each other, including software necessary for their intended use, which are intended by the manufacturer for use on humans for the purposes of:

  • diagnosis, prevention, monitoring, treatment, or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation, or compensation of injury or disability,
  • research, replacement, or modification of anatomy or maintenance of physiological functions,
  • conception control,

provided that their principal effect is not based on the pharmacological, immunological, or metabolic effect. However, they can contribute to introducing into the body or delivering to the surface of the human body agents that cause the above effects.

It is important to understand that, on the one hand, medical devices border on household and industrial products with a similar purpose, and on the other hand, on medicinal products (drugs)! For example, household scales are used to determine weight, just like medical ones. But the latter are a medical device since they are used by a doctor in a medical institution to determine the patient’s weight.

An example of a similar purpose of a medical device and a medicinal product is nasal drops. If they are a saline solution that relieves the symptoms of dryness (moisturizes) and physically rinses the cavity, this is MD. If the drops contain pharmacological substances, for example, substances for constricting blood vessels and vitamins for restoring the mucous membrane, then this is a drug. As can be seen from the definition of a medical device, a drug realizes its effect via pharmacological and metabolic effects.

Mandatory certification of medical devices

Now, to understand which devices require a mandatory certificate or declaration of conformity, one needs to analyze the Russian regulatory documents.

On the territory of the Russian Federation, the need for mandatory certification and declaration is determined by the requirements of:

  • technical regulations of the Russian Federation;
  • technical regulations of the Eurasian Economic Union (for earlier regulations before 2016 – of the Customs Union);
  • documents of the Russian Federation which determine a Unified list of products subject to mandatory certification, and the Unified list of products subject to declaration of conformity (as of 01.09.2022, this list is regulated by the Government Decree No. 2425 dated 12.23.2021, up to 01.09.2022 – by the Government Decree N 982 dated 01.12.2009);
  • EAEU documents which determine a Unified list of products subject to mandatory confirmation of compliance with the issuance of certificates of conformity and declarations of conformity of a unified form (Decision of the Customs Union Commission dated April 7, 2011 No 620, as of 22.02.2023 – Decision of the EEC Council dated 19.08.2022 No. 119).

Thus, to understand which medical devices are subject to certification or declaration, one needs to examine these regulatory documents.

Assessment of the conformity of medical devices in accordance with the requirements of technical regulations of the Russian Federation and the EAEU

To determine whether a particular regulation applies to a medical device, one should take into account its “scope of application”. Currently, there is no separate regulation for medical devices, and most regulations indicate that they do not apply to medical devices. However, some of them contain requirements that apply to MD as well. Let us look at the requirements of regulations that may establish requirements for medical devices.

wdt_ID Name of the regulation* Regulation designation Medical devices subject to the regulation Compliance confirmation method
1 Technical Regulation of the Customs Union “On the safety of low-voltage equipment” TR TS 004/2011 Does not apply to medical products. However, it applies to medical equipment Depending on the type of device, compliance is confirmed in the form of certification or in the form of declaration of conformity
2 Technical Regulation of the Customs Union “On packaging safety” TR TS 005/2011 Does not apply -
3 Technical Regulation of the Customs Union “On the safety of products intended for children and adolescents” TR TS 007/2011 Does not apply -
4 Technical Regulation of the Customs Union “On the safety of machinery and equipment” TR TS 010/2011 Does not apply -
5 Technical Regulation of the Customs Union “On the safety of light industry products” TR TS 017/2011 Does not apply -
6 Technical Regulation of the Customs Union “On the safety of personal protective equipment” TR TS 019/2011 Does not apply to specially designed personal protective equipment for medical use. It may be necessary to receive a certificate of conformity for isolating suits if in addition to medical purposes, they have other types of use: protection from chemical exposure or protection during sanitary and epidemiological measures
7 Technical Regulation of the Customs Union “Electromagnetic compatibility of technical equipment” TR TS 020/2011 Medical devices that can create electromagnetic interference and (or) the quality of operation of which depends on the influence of external electromagnetic interference. These are almost all active electrical devices. As of 11.12.2022, this regulation DOES NOT APPLY to MD Conformity assessment is carried out in the form of a declaration
8 Technical Regulation of the Customs Union “On the safety of furniture products” TR TS 025/2012 Does not apply -
9 Technical Regulation of the Customs Union “On the safety of equipment operating under excess pressure” TR TS 032/2013 Medical devices operating under excess pressure:
- medical air vessel;

- nitrogen monoxide vessel;

- valve vessel for gas mixtures (for example, helium and oxygen, nitrous oxide and oxygen);

- compressed air vessel for surgical instruments;

- carbon dioxide vessel for anesthesia/respiratory therapy;

- carbon dioxide vessel for laparoscopy;

- argon vessel for electrical surgery;

- vessel with calibration gas (for calibrating devices for in vitro diagnostics);

- cylinder reducer for various medical gases;

- medical gas system
Certification by an authorized certification body.
Declaration of conformity based on one’s own evidence and (or) evidence obtained with the participation of a certification body or an authorized testing laboratory (center)
10 Technical Regulation of the Eurasian Economic Union “On restriction of the use of certain hazardous substances in electrical and electronic equipment” TR EAEU 037/2016 Does not apply -

Note: * — the table includes regulations that could potentially apply to medical devices. Such regulations as “On the safety of equipment for children’s playgrounds” (TR EAEU 040/2016), “On the safety of meat and meat products” (TR TS 034/2013), Technical Regulation of the Russian Federation “On the safety of gas distribution and gas consumption networks”, etc. are not listed due to their clear inapplicability to MD.

The field of conformity assessment is very dynamic and therefore changes quickly! The websites of many companies contain outdated information, with reference to long-invalid regulatory documents. We understand the importance of keeping this information up to date and update the content promptly. Thus, according to the Decision of the EEC Council dated June 10, 2022 N 91, as of December 11, 2022, the Technical Regulation of the Customs Union “Electromagnetic compatibility of technical equipment” (TR TS 020/2011) will no longer apply to medical devices!

Thus, today few medical devices are subject to mandatory certification or declaration due to the requirements of technical regulations. There is a tendency for further abolition of the need to obtain certificates and declarations for medical devices.

If the conformity assessment is positive, a mark of conformity is applied to the medical device packaging.

TR TF mark
TR TF mark 2

Mark of conformity with the technical regulations of the Russian Federation that apply to the product.

EAEU mark

Mark of conformity with the technical regulations of the Customs Union and the Eurasian Economic Union, the requirements of which the product meets.

In addition to certification of the medical devices themselves, there is certification of the medical devices manufacture. As a rule, it comes down to certification of the quality management system (QMS). The QMS certificate confirms that the medical device manufacturer meets all requirements to the quality of stages of design and development, production, storage and supply, installation, maintenance, final decommissioning, and disposal of medical devices.

Conformity assessment of medical devices included in unified product lists

National requirements

National requirements and corresponding unified lists are established by the Decree of the Government of the Russian Federation No. 2425 dated 23.12.2021.

Medical devices are not included in the Unified list of products subject to mandatory certification.

Information about medical devices, the conformity of which should be assessed by obtaining a declaration of conformity from the Unified list, is given in the table.

wdt_ID Product type (EAEU CN code) Medical device type and clarifying (associated) code Notes
1 Boxes for medicinal products 4819 10 cartons, cases and boxes, made of corrugated paper or corrugated cardboard

4819 20 cartons, cases and boxes, folding, made of non-corrugated paper or cardboard

4819 30 bags and packages with a base width of 40 cm or more

4819 40 other bags and packages, including sacks
Not so long ago, packaging for medicinal products was identified as a medical device. However, it is currently EXCLUDED from the composition of medical devices. There is no need to obtain a registration certificate, only a declaration of conformity is issued
7 Products for contact lens care 3307 90 000 1 solutions for storage of contact lenses

3307 90 000 2 drops for contact lenses
Medical devices for contact lenses care include: solutions for cleaning lenses (type code 102990), disinfection solutions (type code 115830), solutions for removing protein deposits (type code 115870), rinsing solutions (type code 320670). That means, for storage solutions and lens drops only a declaration of conformity is required. For medical devices listed here with type codes, one needs to obtain a registration certificate

There are other examples of “borderline” cases. Thus, antiseptic paper tissues used in everyday life are subject to declaration (for compliance with the requirements of GOST R 52354-2005). However, if the tissues are intended to disinfect patient’s skin before injection, they are considered a medical device and are subject to registration. In both cases, the base of the tissue and the disinfectant composition can be identical.

Unlike a certificate, it is not the certification body, but the applicant (manufacturer or its authorized representative) who bears full responsibility for the information provided in the declaration of conformity!

Upon successful completion of the conformity assessment, a conformity mark is applied to the packaging.

RST mark
RST mark 2

This mark confirms compliance of the medical device with the requirements established within the framework of mandatory certification. At the bottom of the mark, there is a code of the certification body. If a product receives a declaration of conformity, the certification body code is not applied.

Requirements of regulatory documents of the Eurasian Economic Union

The Unified list of products subject to mandatory confirmation of compliance with the issuance of certificates of conformity and declarations of conformity in a unified form was established by the Decision of the Customs Union Commission dated April 7, 2011 N 620. Currently, this list does not include medical devices. Therefore, the need for mandatory conformity assessment is determined solely by the national List, which we discussed above.

Information on issued certificates and declarations of conformity is given in the Unified register of the Federal Accreditation Service:

You can determine under what legislation the certificate or declaration is issued by looking at its number. If it begins with “ROSS RU”, this means that the document has been received within the framework of the Russian Federation legislation. If the number contains “EAEU”, then it has been issued within the EAEU.

Currently, Russia and the Eurasian Union are taking significant measures to eliminate duplication during conformity assessment of medical devices. Thus, the previously existing duplication of tests carried out both during state registration and issuance of certificates (declarations) of conformity is gradually being removed. The abolition of the need for mandatory certification (declaration) of medical devices eliminates this duplication and significantly reduces the regulatory burden on manufacturers and their authorized representatives. Now tests are carried out mainly within the framework of the state registration of medical devices!

Documents for certification of medical devices in Russia

The standard list of documents includes:

  • information about the applicant (name of the legal entity, entity details), a copy of the applicant’s organizational documents (Charter, Tax Reference Number/INN, Primary State Registration Number/OGRN);
  • name of the medical device, its intended use, operational documentation (instruction for use or operating manual);
  • technical specifications for the MD, production process flowcharts, technical maps, and other technical documentation (if available);
  • document confirming the right to production premises (lease agreement or certificate of ownership);
  • registration certificate from Roszdravnadzor (if available);
  • information about previously issued authorization documents (if any);
  • supply contract (agreement), data sheet (for imported medical devices);
  • application for conformity assessment on behalf of the head of the manufacturing organization or its authorized representative.

Procedure for conformity assessment of medical devices

To obtain authorization documents:

  • send us a request for conformity assessment;
  • based on the results of the application assessment, we provide a free consultation on all related issues: we select the assessment form, the most suitable confirmation method, and advise on terms and cost;
  • together with you, we prepare a package of all required documents (we develop the documents if they are lacking). This stage is defining, since the success of the entire procedure depends on the quality and content of the documentation;
  • we select product samples and conduct tests (research) in authorized laboratories (if necessary);
  • we carry out a manufacturing site inspection (if it is required by the confirmation method). We try to find a method that avoids the stage of inspection;
  • you receive test (research) reports and a document that confirms product compliance.

Simplification of certification of medical devices

The economic sanctions imposed on the Russian Federation also affected the availability of imported medical devices. Therefore, the Russian Government has taken additional measures to reduce the regulatory burden. Thus, Appendix 18 of the Decree of the Government of the Russian Federation dated 12.03.2022 N 353 “On the specifics of licensing activities in the Russian Federation in 2022” contains several improvements that significantly simplify the assessment of conformity:

  • planned inspection control of certified products in the form of an analysis of the manufacturing site can be conducted remotely (via audio and video conference calls) and (or) research (tests) and measurements of samples (probes) of products;
  • the certification body may postpone periodic inspection control for up to 6 months;
  • the validity period of conformity assessment documents expiring before September 1, 2022 is extended by 12 months;
  • it is allowed not to submit documents on the conformity assessment for certain types of products to the customs authorities;
  • until March 1, 2023, it is allowed to import into the territory of the Russian Federation products intended for circulation exclusively on its territory, without labeling established by mandatory requirements. This includes marks of conformity;
  • from March 21, 2022 to September 1, 2023, for products the conformity of which is confirmed by evidence obtained with the participation of an authorized testing laboratory (center), it is allowed to conduct an assessment in the form of a declaration of conformity based on the applicant’s own evidence (protocols of production laboratories, protocols of third countries).

Voluntary certification of medical devices in Russia

Voluntary certification confirms the compliance of a medical device with standardization documents (GOST, TU, etc.), voluntary certification systems, and the terms of contracts on a voluntary basis. Even though it is voluntary, the certification procedure is determined by state regulations. The main regulation in this case is the Federal Law dated December 27, 2002 N 184-FZ “On technical regulation”.

There is no voluntary declaration of products in the Russian Federation!

Purpose of voluntary certification

Based on the results of confirming the compliance of a medical device, a voluntary certificate is issued. The main goals of obtaining a voluntary certificate for medical devices are:

  • increasing the awareness of the brand and its image among the consumers;
  • additional competitive advantage during participation in tenders, auctions, and competitions;
  • priority advantage when receiving subsidies, grants, and state benefits;
  • increasing the investment prospects of the manufacturing company, expanding its market share and sales volumes;
  • proving the manufacturer’s desire to produce reliable, safe, and high-quality products that meet more than just mandatory requirements.

Voluntary certification does not replace mandatory certification if the legislation establishes requirements for mandatory confirmation of compliance (both in the form of declaration and certification)!

Voluntary certification systems

The most previously known certification system GOST R (Rosstandart system) is currently not in effect (canceled by the Rosstandart order No. 3358 dated December 26, 2019). Today, the largest state voluntary certification system is the “National Certification System” (registration number ROSS RU.0001.03НСС0) under the management of the Federal State Budgetary Institution “Russian Institute of Standardization”. It has replaced the GOST R system.

Today there are over 1000 voluntary certification systems. The Russian Federation Rosstandart registers and records them within a special register.

Procedure for voluntary certification

The procedure and rules for voluntary certification are regulated by GOST R 54659-2011 “Conformity assessment. Rules for voluntary certification of services (works).”

A voluntary certificate of conformity is issued by authorized certification bodies. The procedure for voluntary product certification is conducted according to the same rules and methods that are used for mandatory certification of a medical device.

To do this, the applicant (manufacturer or their authorized representative) submits an application, selects a suitable confirmation method, and, depending on the method, provides documents and product samples for testing. Based on the tests, it is decided whether the MD complies or does not comply with the specified requirements and whether a certificate for the MD can be issued.

If the certification result is positive, a special form (certificate) is issued and a mark of conformity is applied to the packaging of the medical device. Each certification system establishes its own mark of conformity. The mark of the national state certification system is shown in the figure.

voluntary certification mark
voluntary certification mark 2

Along the outline of the national state certification (“PCT” in Russian) mark is the inscription “voluntary certification” to inform the consumer about the voluntary confirmation of compliance.

Roszdravnadzor registration certificate

Registration certificate is the main authorization document for any medical device. That is why it is obtained before a certificate or a declaration.

In accordance with the Order of the Ministry of Health of the Russian Federation dated August 30, 2021 N 885n, as of March 1, 2022, during registration of a medical device its compliance is assessed in the form of:

  • technical tests (quality and safety testing);
  • toxicological tests (if the use of a medical device for its intended purpose involves contact with the human body, mucous membranes, internal environments of the body). These tests may include determination of sanitary-chemical parameters, assessment of biological parameters in vitro and in vivo, as well as microbiological tests;
  • clinical trials (assessment of clinical safety and effectiveness of the device). Find out more about clinical trials in this article.

Technical tests and toxicological tests can only be conducted in laboratories authorized by the national system (they have an accreditation certificate from the Federal Accreditation Service and are listed in the Register of accredited persons).

Clinical trials are conducted by medical institutions that meet the requirements of the Order of the Ministry of Health of the Russian Federation dated May 16, 2013 N 300n. A list of such institutions is given on the Roszdravnadzor website.

You can find more details (procedure, stages, flowcharts, terms, cost, etc.) about the procedure for medical device registration here:

For the last two types, there is a strict list of products that can be subject to these “simplified” registrations.

The most popular and universal is the state registration in accordance with the Government Decree N1416 dated December 27, 2012 (i.e. according to the national rules).

Classification of medical devices based on the degree of potential application risk

The complexity, duration, and final cost of confirming compliance are determined primarily by the potential risk of device application. The reason is that collecting evidence of quality, efficacy and safety for high-risk medical devices requires significant costs. Thus, the cost of development and amount of testing will be much greater for a heart valve than for non-sterile latex gloves.

In accordance with the Order of the Ministry of Health of the Russian Federation dated June 6, 2012 N 4n, depending on the potential risk of medical device application, all medical devices are divided into four classes:

  • class 1 – low degree of risk (non-sterile disposable clothing, disposable shoe covers);
  • class 2a – medium degree of risk (sterile surgical clothing, reagent kits for in vitro diagnostics of non-hazardous infectious diseases, many dental materials);
  • class 2b – enhanced degree of risk (surgical staplers, catheters, laser devices and systems);
  • class 3 – high degree of risk (joint endoprostheses, heart valve, implants, MD for in vitro diagnostics of pathogens that threaten human life or have a high risk of spreading).

Please note that a single device can belong only to one risk class!

Assignment of MD to a particular class is based on the following criteria:

  • duration of MD use (longer duration increases the risk degree);
  • invasiveness of medical devices (devices placed inside the body or its cavities have a higher application risk);
  • involvement of contact with or interaction with the human body (risks for the end user of a medical device during contact also increase the overall risks of the medical device application);
  • method of introducing MD into the human body (through anatomical cavities or surgically);
  • application of medical devices to vital organs and systems (heart, circulatory system, central nervous system);
  • use of energy sources (involvement of electrical, mechanical, thermal, and other types of energy may create additional risks).

Complexity of the state registration of medical devices (duration, cost, and amount of required evidence) is directly related to the potential application risk.

Registration of medical devices ends with the issue of a registration certificate and the addition of information about the device to the state register of medical devices and organizations engaged in their production and manufacturing.

Which products are not subject to state registration?

Devices which are not mass-produced, but are custom-made for a specific patient and are intended for personal needs (Part 5, Article 38 of Federal Law No. 323) do not require a registration certificate! An example of such a device is lower limb prostheses for individual use.
Medical devices that are imported into the Russian Federation for use in the territory of international medical clusters or the territories of innovative scientific and technological centers (for example, the Skolkovo center) are also not subject to registration.

Certificate of approval of measurement instrument type

Some medical devices with a measuring function are classified as measuring instruments and therefore should be assessed for compliance with the accuracy of the measurements. That involves a series of tests in accordance with the program. The procedure and rules for conducting tests in order to approve the type of measuring instruments for medical devices regarded as measuring instruments are determined by the Order of the Ministry of Health of the Russian Federation dated August 15, 2012 N 89n. Such tests are conducted by organizations that are accredited to perform testing for the purpose of approving the type of measuring instruments.

A certificate (Certificate of approval of measurement instrument type or “SUTSI” in Russian) is necessary for the following types of measuring instruments, which are also medical devices:

  • thermometers;
  • scales;
  • height meters;
  • dynamometers;
  • ergometers;
  • blood pressure monitors;
  • devices for examination of external respiration parameters (spirographs, pneumotachographs, etc.);
  • devices for examination of the composition of inhaled and exhaled air (oximeters, carbonometers, breathalyzers);
  • kits of trial spectacle lenses;
  • medical audiometers;
  • universal clinical dosimeters for radiation therapy;
  • clinical X-ray dosimeters;
  • photon radiation dosimeters for radiation monitoring at personnel workplaces;
  • clinical radiometers;
  • photometers, spectrophotometers, medical laboratory photocolorimeters.

Decree of the Government of the Russian Federation dated November 16, 2020 N 1847 “On approval of the list of measurements related to the scope of state regulation to ensure the uniformity of measurements” establishes the types of measurements which are subject to this requirement. One has to carefully compare the type of measurement and the type of measuring instrument. Thus, section 1 of the List of measurement types includes “temperature measurements by contact method”. That means a mercury thermometer requires a certificate of approval of measurement instrument type, while a non-contact IR thermometer does not.

Safety data sheet for medical devices

Medical devices for in vitro diagnostics often require a chemical safety data sheet. This is necessary because many reagents contain substances that can be harmful to human health and the environment if used incorrectly.

This is especially true for products that contain highly toxic substances, as well as carcinogenic, mutagenic, and teratogenic compounds. For example, GOSTR 59722-2021 regulates the issuance of a safety data sheet for reagents for staining biological material used in medical laboratories.

In Russia, GOST 30333-2007 establishes the basic requirements for a safety data sheet. For some products, the safety data sheet is a mandatory part of the technical documentation. It serves to provide the consumer with information on the safety of use, storage, transportation, and disposal of the product, as well as its intended use.

Foreign manufacturers of in vitro reagents issue safety data sheets (“SDS” for short) in accordance with the regulations (in the EU it is REACH Regulation) or standards which are valid for the manufacturing country.

To import and obtain authorization documents in the Russian Federation, safety data sheets should be translated into Russian. The validity period of the safety data sheet depends on the degree of danger of substances. As a rule, it is as follows:

  • for highly dangerous and extremely dangerous substances – 3 years;
  • for slightly hazardous and moderately hazardous chemicals – 5 years.

Do I need a quality certificate for a medical device?

Certificate of quality passport is an official statement by the manufacturer about the consumer and quality characteristics of its product. Formally, it is a part of design documentation.

Regulatory documents establish the need for such a certificate for particular types of products. Medical devices are not included in the list of such products. Therefore, they do not require a quality certificate.

Sanitary and epidemiological inspection report

Sanitary and epidemiological inspection report (hygienic certificate) is a document that confirms that a product, a type of activity or technical conditions comply with established sanitary and hygienic rules and standards in accordance with the current sanitary standards of the Russian Federation.

Up to 01.06.2010, territorial branches of Rospotrebnadzor issued inspection reports. Currently, certificates of state registration are issued instead.

Certificate of state registration

Certificate of State Registration is a document that confirms that the product fully complies with the sanitary and epidemiological requirements established in the territory of the Eurasian Economic Union (formerly the Customs Union) and has successfully passed the state registration procedure.

The document is issued based on the results of tests (research) and an expert opinion (issued by Rospotrebnadzor in the territory of the Russian Federation). This certificate is mandatory for:

  • products included in the “List of products subject to state registration” (to check compliance with the Unified sanitary, epidemiological, and hygienic requirements for products. See the Decision of the Customs Union Commission No. 299 dated 18.06.2010);
  • products, where the technical regulation (or technical regulations) establishes that compliance can be confirmed in the form of state registration.

Currently, there are no medical devices which need a Certificate of state registration. However, there are borderline cases, where certain difficulties arise. Thus, a diaper for children is a sanitary and hygienic product (not medical), which requires a certificate of state registration. Meanwhile, a diaper for children with incontinence is a medical device and therefore requires the Roszdravnadzor registration certificate.

At the same time, the manufacture of these products can be identical, with slight differences in the labels and instructions for use. This is why regular diapers have been recently excluded from the Register of registered medical devices, and the manufacturers received a certificate of state registration instead.

If you have doubts about classifying a product as a medical device and the need to receive a certificate, a declaration, or a registration certificate, please contact us and we will be happy to help you figure it out!

Exemption letter for medical devices

This document confirms that your device is not subject to mandatory conformity assessment, i.e. does not require a certificate or a declaration. An exemption letter is issued by certification bodies upon request from the manufacturer (or its authorized representative) or importer of the device.

Regarding the need to obtain a registration certificate for medical devices, Roszdravnadzor can issue an exemption letter.

Often such letters are required for customs clearance of foreign products when they are imported into the territory of the Russian Federation.

Do I need a license to sell medical devices?

The Federal Law “On licensing of certain types of activities” dated 04.05.2011 N 99-FZ states that the sale of medical devices does not require a license. However, an appropriate license is mandatory for Russian organizations that provide maintenance of medical devices.

What authorization documents are still required?

Considering the variety of forms of compliance confirmation it is very important to choose correctly. The law establishes administrative and even criminal liability for the absence of the necessary authorization documents. KC-PROF company is always ready to help manufacturers and distributors of medical devices make the right choice and quickly obtain the necessary documentation.

Our experts will advise you on any issues related to the circulation of medical devices, and will also help with obtaining the necessary authorization documents (certificate and/or declaration of conformity, exemption letter, Roszdravnadzor registration certificate, etc.). You can request a free consultation by calling 8 (800) 250-03-48 or using any feedback form convenient for you.

Why us?

  • a team of experts with many years of experience in the field of conformity assessment of medical products and medical equipment;
  • hundreds of successfully completed projects and thousands of authorization documents received;
  • long-term partnership with leading accredited laboratories and certification bodies. This allows to minimize the time and cost of testing (research), as well as eliminating claims from regulatory authorities;
  • full compliance of the developed documents with current legislation in the field of circulation of medical devices and assessment of their compliance;
  • full range of services: from development of documentation for devices manufacture to post-sale monitoring;
  • vast experience in eliminating inconsistencies identified by supervisory authorities as part of state control;
  • certification and declaration according to the method which will be most profitable and convenient for you;
  • support on any other issues related to any stage of medical device circulation;
  • full transparency of work at any stage aimed at quick obtaining of documentation on devices conformity at minimal cost.