Registration Certificate for a Medical Device

In this article, we will discuss major details and subtleties of obtaining a registration certificate for medical devices in Russia. We are glad to help you with any issues that arise in the process of registration, as well as to provide all necessary services on a turnkey basis.

What is a registration certificate for a medical device?

Registration certificate is a document of the established form which confirms the fact of registration of a product as a medical device and its inclusion in the Russian Federation Register of Medical Devices. The State Register is currently maintained by the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

Registration certificate is an official recognition of quality, effectiveness and safety of a medical device by the state authorities and of its compliance with all the requirements imposed on medical devices.

Part 4 of article 38 of Federal Law No. 323-FZ dated 21.11.2011 “On the bases of the citizens health protection in the Russian Federation” allows circulation only of those medical products that have been registered in the Russian Federation and received an appropriate registration certificate.

Without a registration certificate, a medical device cannot be manufactured, imported, sold or used. In other words, any form of its circulation on the market is prohibited.

Registration certificate is often referred to as “RC”, an abbreviation which became common among specialists in this field. We are also going to use it in the text from now on.

Before the current registration Rules came into force, all medical devices were divided into “devices for medical purposes “and “medical equipment”. This division was reflected in certain aspects of registration. Today, this division is conditional and still has an influence due to rigidity in the adoption of regulatory documents in the field of medical devices circulation. Thus, the concept of “medical equipment” is still used in regulatory documents related to licensing of the production and maintenance of certain medical devices: those that belong to this category.
For this reason, the task of obtaining a RC for a device for medical purposes and/or medical equipment means registration of this medical device.

In addition to that, the term “medical equipment” is often used for customs clearance of import/export of medical products within the EAEU. The declarations specify the EAEU CN FEA codes (commodity nomenclature of foreign economic activity in the Eurasian economic Union). Therefore, circulation of a medical device not only on the territory of the Russian Federation, but also within the EAEU countries, requires a registration certificate for medical equipment by the EAEU rules.

Some market participants also refer to this document as a “registration certificate of the Ministry of Health”. The reason might be that according to the Regulations on the Federal Service for Surveillance in Healthcare, Roszdravnadzor is under the supervision of the Ministry of Health.

Why does one need a Roszdravnadzor registration certificate?

According to the current regulatory documents, in addition to mandatory certificates and declarations of conformity, each medical device requires mandatory registration. The rules and procedure for obtaining a RC for a medical device are listed in the Decree of the Government of the Russian Federation No. 1416 “On Approval of the Rules for State Registration of Medical Devices” dated December 27, 2012. Accordingly, the procedure itself is called “state registration”. A RC for a medical device is an official confirmation that the product has successfully passed state registration.

That is why receiving a registration certificate for medical devices is a prerequisite for their legal circulation in the Russian Federation both for domestic and for foreign products.

Registration certificate for a medical device is issued by Roszdravnadzor (the full form is Federal Service for Surveillance in Healthcare), which is an executive authority under the direct jurisdiction of the Ministry of Health of the Russian Federation. It performs the functions of control and supervision in the field of healthcare. Therefore, the terms “registration authority” or “regulator” in all regulatory documents related to the procedure of medical devices registration refer to Roszdravnadzor.

When does one need to apply for a registration certificate for a medical device?

Registration certificates should be issued for all medical devices, both domestic and foreign (imported).

Medical devices are any instruments, devices, appliances, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories, including special software, necessary for the use of these products for their intended purpose and intended by the manufacturer to prevent, detect, treat and rehabilitate diseases, to monitor the state of human body, to conduct medical research, to recover, replace, or alter the anatomical structure or physiological functions of the body, to prevent or terminate pregnancy. At that, the functional purpose of these products is not realized by pharmacological, immunological, genetic or metabolic effects on the human body.

Despite the existence of a detailed definition, in real practice there are many cases where it is quite difficult to determine if the product belongs to medical devices. It is especially problematic if the product includes a drug. Thus, nasal products can be either drugs or medical devices, depending on their composition and purpose.

It is for such cases in particular that we have prepared a section where we describe how to accurately determine if your product is a medical device.

When is it unnecessary to receive a registration certificate for a medical device?

You don’t need to receive a RC for:

  • products manufactured by individual orders of patients, which are subject to special requirements in accordance with an appointment by medical professionals, and are intended exclusively for personal use by a particular patient (part 5 of article 38 of Federal Law No. 323). For example, a lower-limb prosthesis for individual purposes;
  • medical devices intended for use on the territory of an international medical cluster or on the territory of innovative scientific and technological centers (part 5 of article 38 of Federal Law No. 323). An example of such a cluster is the international medical cluster on the basis of SKOLKOVO.

Certain types of medical device circulation are allowed before receiving a registration certificate:

  • import of foreign medical products for the limited period of their registration (circulation is restricted to the use in technical tests, toxicological researches, clinical trials, examination of quality, efficacy and safety of medical devices, state registration itself, importation into the territory of the Russian Federation, conformity assessment, state control, storage, transportation) (regulated by the Order of the Russian Federation Ministry of Health dated 15.06.2012 No. 7n);
  • manufacture of domestic medical devices for testing and (or) research (paragraph 1 of part 15 of article 38 of Federal law No. 323).

In other words, these types of circulation do not refer to independent use of the products by a final customer.

As of September 1, 2020 the Decree of the Russian Federation Government No. 1335 dated September 1, 2020, added the following items to the list of medical devices that are not subject to state registration:

  • products imported into the customs territory of the Union by individual citizens and intended for personal use;
  • products which are manufactured on the territory of a member state by individual orders of patients exclusively for personal use, and are subject to special requirements following the appointment issued by a medical professional;
  • products imported into the customs territory of the Union to be applied by employees of diplomatic missions and consular offices;
  • products imported into the customs territory of the Union to provide medical assistance to passengers and crew members of vehicles, train crews and vehicle drivers that arrived on the territory of the Union;
  • products imported to the customs territory of the Union to provide medical assistance to participants of international cultural and sports events, and participants of international expeditions, as well as products imported for the exhibition purposes;
  • products imported into the customs territory of the Union for research (testing), including scientific research;
  • products imported into the customs territory of the Union as humanitarian aid in cases determined by the legislation of the member States.

In addition to that, in response to the coronavirus pandemic, a simplified registration procedure was developed to speed up the registration of medical products intended for use in an unfavorable epidemiological situation. We will discuss it in detail in the article devoted to this topic.

What is the validity period of a registration certificate for a medical device?

Registration certificate for a medical device is issued indefinitely. However, as of now the Rules for Registration of Medical Devices within the Eurasian economic Union (EAEU) have been developed and came into force. Even though the RC issued under the Russian registration Rules will remain valid indefinitely, after 31.12.2021 it will be impossible to introduce changes to the RC, as well as to the documents in the registration dossier. In other words, the national RC will remain valid until there is a discrepancy between the information indicated in the RC or provided in the registration dossier and the actual data on the circulation of the registered medical product. Changes may include amendments to the design of the product, change in the name of the legal entity, in the address of the place of manufacture, etc.

However, there is reason to believe that amending the documents for a medical device will still be possible after 31.12.2021! Below we will discuss the legislative initiative which allows making changes under the national rules, but has not yet been adopted at the level of all the EAEU countries.

Terms of obtaining a registration certificate

Each product is unique. This means that the amount of documentation, the scope of testing, and other evidence of quality, effectiveness, and safety differ significantly from one product to another. Therefore, it is quite difficult to predict the exact period for receiving a RC. However, based on our working practice and experience, the average periods for receiving a RC for medical devices are the following:

  • Risk class 1 – 6 months;

  • Risk classes 2a and 2b – 8-10 months;

  • Risk class 3 – 12 months.

The terms may increase, for example, if there is a need to conduct tests for approval of the type of measuring instruments; to conduct long-term clinical trials not as analysis and evaluation of clinical data, but in the form of actual tests with human participation (in case of innovative and unique products).

The terms of administrative actions and procedures for the provision of public services in Roszdravnadzor are determined by the Decree of the Government of the Russian Federation No. 1416 dated December 27, 2012!

We do our best to make the time required to receive a registration certificate as short as possible by performing simultaneously several registration procedures. In addition, if you have completed certain stages of registration at the time of contacting our company, it will also allow you to get a registration certificate for a medical device in the shortest possible time.

What information is indicated in the registration certificate for a medical device?

Registration certificate of Roszdravnadzor is issued on a form of the established layout. Each medical device registration certificate has a unique number assignment for accounting and protection against forgery.

Registratuon certificate

Sample of the registration certificate for a medical device

The RC contains the following information (see the sample RС):
1 – date of the medical device state registration and the registration number of the certificate;

2 – name of the medical device. Please, note that information about the accessories necessary for the intended use of the medical device is also indicated. Detailed information about accessories is provided In the Appendix to the RC (see the drawing);

3 – full and (if available) abbreviated name of the legal entity in whose name the registration certificate was issued, including name, legal form and address (location) of the company;

4 – manufacturer (producer) of the medical device: full and (if available) abbreviated name, including the name, legal form and location address of the company, or last name, first name and (if available) patronymic name, details of the identity document, place of residence of the individual entrepreneur;

5 – place of manufacture of the medical device;

6 – the number of the registration dossier. It allows you to identify the set of registration documents which is stored in Roszdravnadzor;

7 – class of potential risk of the medical device application determined by the nomenclature classification of medical devices;

8 – code in accordance with the All-Russian classifier of products by type of economic activity (OKPD 2 code);

9 – number of sheets in the Appendix to the RC;

10 – number and date of the order of Roszdravnadzor, on the basis of which the medical device is approved for application in the territory of the Russian Federation;

11 – position and full name of the authorized person who approved the RC;

12 – number of the RC form.

appendix to the registration certificate

Sample of the appendix to the registration certificate for a medical device

The registration certificate is often accompanied by an appendix. It contains the following information (see the sample appendix):

1 – design variants;

2 – composition of the medical device;

3 – accessories to this medical device;

4 – position and full name of the authorized person who approved the appendix to the RC;

5 – number of the appendix form (for accounting and protection against forgery).

The Rules of national registration allow you to introduce changes to the registration certificate. In other words, you can change the information indicated in the RC and its Appendix.

Which approval documents does a medical device need in addition to the RC?

Organizations that apply medical devices in their activities in the process of selection and purchase of medical products should request the following documents from their seller:

  • copy of the Registration certificate with the appendix;
  • copies of Certificates of conformity (if the medical device is subject to mandatory certification, following the Decree of the Government of the Russian Federation No. 982dated 01.12.2009);
  • copies of the Declaration of conformity (if, in accordance with the Decree of the Government of the Russian Federation No. 982 dated 01.12.2009, the confirmation of conformity is required in the form of a Declaration of conformity);
  • copy of the Certificate of approval of the measuring instrument type (if the medical device belongs to measuring instruments in accordance with the requirements of the Order of the Ministry of Health of the Russian Federation No. 89n dated August 15, 2012).

These documents should be retained, as Roszdravnadzor may request them during state control of the quality and safety of medical activities.

Documents required for receiving a registration certificate

The list of documents required to receive a registration certificate is provided in paragraph 10 of the Decree of the Government of the Russian Federation No. 1416 dated 27.12.2012. However, that list is compiled in a general way and does not account for specifics of different medical devices. For instance, sub-clause “b” of clause 10 requires the provision of “technical documentation from the manufacturer (manufacturer) for the medical device”. However, the set of technical documentation in each case is very different both in composition and content.

In addition, there are differences between list of documents for the medical devices manufactured in Russia and abroad. To make it easier to understand the differences in the content of documentation, we developed a comparison table. Depending on the specifics of the medical device, the table will indicate the need to provide a particular document as part of the registration dossier. The additional notes include important commentaries related to certain documents and provide useful links to the websites where these specific aspects are discussed in detail.

List of documents to receive an RC

wdt_ID No. Document name Product of Russian origin Product of foreign origin Note
1 1 Application for registration Mandatory Mandatory Current application form
2 2 List of documents (list of documents attached to the application) Mandatory Mandatory Current form for the list of documents
3 3 A copy of the document confirming the authority of the authorized representative of the manufacturer (producer) Mandatory The authorized representative is needed for the products of foreign origin. Functions, responsibilities and other important aspects of the services, which the authorized representative of the manufacturer performs, are discussed on this page of the website
4 4 Information about the regulatory documentation for a medical device Mandatory Mandatory
5 5 Technical documentation for a medical device from the manufacturer (producer) Technical requirements. Developed in accordance with the requirements of the Order of the Ministry of Health of the Russian Federation No. 11n and GOST 2.114-2016 Extract from the technical file developed in accordance with the Order of the Ministry of Health No. 11n
6 6 Operating documentation for the medical device from the manufacturer (producer), including instructions for use or operating manuals for the medical device Mandatory Mandatory
7 7 Photographic images of the general appearance of the medical device with accessories required for the operation of the medical device (min.18x24 cm in size) Mandatory Mandatory A photographic image should allow to distinctly identify the product. Photos of accessories for the medical product should also be provided
8 8 Design file with reference to operational suitability

If required

In accordance with GOST R MEK 62366-2013

If required

In accordance with IEC 62366-1:2015

It is only in rare cases that the registration authority requests this document
9 9 Qualification test report Mandatory Not required The report confirms that the medical device is ready for mass production
10 10 Risk analysis file for the medical device Mandatory

Mandatory

As part of the technical file

You can find more details about the development of risk analysis file in this article

Documents for the devices of foreign origin must be translated into Russian and certified following the established procedure. We discuss appropriate authorization of documents for medical devices of foreign origin, including a power of attorney for an authorized representative of the manufacturer, in an article dedicated to this topic.

As can be seen in the table above, the differences between documentation for devices of domestic and foreign production are mainly determined by legal aspects. The latter arise from the deviations in the Russian and foreign legal fields. Thus, for medical products manufactured in the European Union, compliance with Directives and/or Regulations is mandatory, and the manufacture conditions should be certified with a quality management certificate. Aside from that, each country usually has its unique form of the documents confirming the registration of the manufacturing organization as a legal entity, which is established by the relevant regulations.

Thus, despite the differences in the lists of documents that should be provided, these documents in both cases contain objective information which confirms the quality, effectiveness, and safety of the medical device and its manufacture conditions.

The documents listed in the table form the main part of the medical device registration dossier. The concept “registration dossier” is officially determined as a set of documents submitted for state registration, introduction of amendments to registration documents, as well as of copies of decisions issued by the registration authority in relation to a specific medical device.

The table also shows that in some cases additional documents should be submitted. Thus, if the application of medical devices refers to the field of state regulation of ensuring the measurements uniformity, it needs a certificate of approval of the measuring instruments type (SI certificate). Examples of such products include medical thermometers, medical tonometers, spirographs, oximeters, carbonometers, breathalyzers, etc. The full list of products is contained in the Order of the Ministry of Health of the Russian Federation No. 89n dated 15.08.2012.

For products that are delivered to the consumer in sterile condition, one needs to provide information about the validation of the sterilization process. For medical software one provides documents confirming the validation of medical software.
Documents confirming the quality of the medication, pharmaceutical substance, biological material and other substances, which were used in the manufacture of a medical device or included in its composition. We discuss the features of registration with medication in their composition in a separate article.

Certificate of the trademark state registration, if it is indicated on the packaging of medical products. Documents confirming other means of individualization of a medical device – also in those cases when they are indicated on the packaging.

The procedure for registration of medical devices and receiving an RC, its individual stages with account for the specifics of medical devices are described in detail this section of the website.

Term of validity of the registration certificate for a medical device

Before the current state registration Rules came into force (i.e. before 2007), registration certificates had the following validity periods:

  • for medical equipment (products requiring maintenance) – 10 years from the date of registration;
  • for devices for medical purpose (products that do not require maintenance) – 5 years from the date of registration.

Starting from 2007, Roszdravnadzor has been issuing registration certificates indefinitely.

Since the Government Decree No. 1416 came into force, the concepts of “devices for medical purposes” and “medical equipment” have been combined into a common one – “medical devices”. To complete the transition to a new definition, it is planned to replace the old termless RCs with the new ones until January 1, 2021. The latest versions of N 323-FZ dated November 21, 2011 also use the term “medical devices”. However, there are still indefinite of the old format in circulation, which should be replaced before January 1, 2021.

It is important to remember that the registration certificate can be revoked for the following reasons:

  • at the request of the applicant to cancel state registration (i.e. at the manufacturer’s request);

  • upon the court decision on violation of the copyright holder rights to the results of intellectual activity and equated means of individualization during circulation of medical devices;

  • if during the state supervision of medical products circulation Roszdravnadzor receives information confirming the facts and circumstances endangering the life and health of citizens and medical workers during operation of medical devices (this information can be received through planned or unplanned investigation upon a specific application (complaint) from citizens and legal entities, or through the results of test purchases);

  • if during the state supervision of the medical devices circulation Roszdravnadzor exposes unreliable information in the documents contained in registration dossier which were submitted by the applicant and influenced the results of the quality, efficacy and safety examination of medical devices.

Types of registration certificates

Currently, medical devices with the following types of registration certificates are in circulation on the territory of the Russian Federation:

  • indefinite (the majority of medical devices);

  • temporary (with a set expiration date).

Temporary RCs are issued in accordance with the Decree of the Government of the Russian Federation No. 430, dated April 3, 2020. This registration certificate can be obtained for a series (lot) of medical devices. Their validity period is until January 1, 2022 (see the Decree of the Government of the Russian Federation No. 1826 dated 13.11.2020). An important feature of these registration certificates is that they also indicate the series (lot) numbers and assembly numbers (if available) of medical devices.

The list of products for which you can receive a temporary registration certificates is limited and is given in Appendix 1 to the Decree of the Government of the Russian Federation No. 430 dated April 3, 2020.

For medical devices listed in Appendix 1 to the Decree of the Government of the Russian Federation No. 299 dated March 18, 2020, it is possible to obtain an RC within a shorter period of time than during the standard state registration procedure. Such RCs are issued until their quality, efficiency, and safety are confirmed during examination.

The confirmation should be conducted within 150 business days from the date of issue of the RC. Once the confirmation is complete, a termless RC is issued. Examples of such products are isolation suits, examination/treatment gloves, protective gowns, face masks, respirators, shoe covers, etc. These products are intended for use in the period of the coronavirus pandemic. This allows meeting the greatly increased demand for these products on the market.

What will happen to registration certificates after the end of the transition period?

The legal aspects referring to regulation in the sphere of medical devices circulation in connection with the transition to the EAEU Rules are very dynamic and therefore require constant attention and analysis of new and already adopted legal acts, which are periodically supplemented and amended. One of the key questions is the fate of registration certificates received under the national rules: what will their status at the end of the transition period be, and when will they expire?

As of today, the end of the transition period for registration within the EAEU is scheduled for 31.12.2021. However, according to the Order of the Board of the Eurasian economic Commission No. 142 dated September 2, 2019, the Agreement on common principles and rules for the circulation of medical devices (medical devices and medical equipment) within the framework of the Eurasian economic Union is planned to be amended. If the Order is adopted it will determine that:

  • RCs issued under the national rules will be valid on the territory of the member states until the end of their validity period:
    for the Russian Federation – an indefinite period;
    for the Republic of Kazakhstan – 5 years;
    for the Kyrgyz Republic – an indefinite period;
    for the Republic of Belarus – 5 years;
    national registration procedure has not been developed for the Republic of Armenia.
  • If the RC has a limited validity period (see above), the product can be re-registered by national rules until 31.12.2026 (in this case, the expiration date of the RC will also be determined by the validity period defined by the national regulations). It is important to note that one will still have the right to make changes to these RCs and to the registration documents without any restrictions (if this Order is not adopted, changes to the nationals registration dossiers and certificates cannot be made);
  • new RCs by the national rules can only be received before 31.12.2021. After that it will only be possible to apply for registration by the EAEU rules.

Important implications:

  • within the transition period, manufacturers of medical devices have the right to choose between the national and the EAEU rules for registration of their product;
  • there is no need to re-register medical device if it has a termless registration certificate received under the Russian rules and is applied in the Russian Federation only;
  • until 31.12.2021, parallel (simultaneous) registration of medical devices both by the national rules and by the EAEU rules is theoretically acceptable. However, it is not necessary from a practical point of view;
  • if you plan to receive a registration certificate in the nearest future, we recommend that you do it according to national rules before 31.12.2021. Receiving the EAEU registration certificate is more expensive and requires a longer period of time.

Can I use medical devices with an expired RC?

This question often arises for final users (customers) of medical devices who purchased the product within the validity period of its RC which has not yet expired.

The regulatory body has the following opinion with regard to this situation: medical devices manufactured and imported for circulation during the validity period of their RCs can be used until the end of validity of the RCs (expiration date).

Cost of registration certificate for a medical device

The cost of receiving a registration certificate for a medical device depends on its risk class, design features (electrical, implantable, inclusion of software, etc.), purpose, number of design versions, sterility, country of manufacture, presence of registered analogues, and many other factors. They determine the amount of documentation and testing required to confirm the quality, effectiveness, and safety of the product, as well as the procedure and number of stages of the registration process of the medical device.

The average cost of our services is:

  • for risk class 1 – from 400,000 rubles;

  • for risk class 2a – from 450,000 rubles;

  • for risk class 2b – from 500,000 rubles;

  • for risk class 3 – from 600,000 rubles.

One should also take into account the cost of testing. This component of the total cost is also variable and differs greatly depending on the product.

In addition, when registering products of foreign origin one should consider the costs of translation and notarization of the required documents from the registration dossier.

The fixed component of the total cost are the state fees established by the Article 333.32.2 of the Tax code of the Russian Federation:

  • fee for the issue of a registration certificate – 7 000 rubles (for all products);

  • fee for the examination of the quality, effectiveness, and safety of a medical device (depends on the risk class of the device):
    – class 1 – 45,000 rubles;
    – class 2a – 65,000 rubles;
    – class 2b – 85,000 rubles;
    – class 3 – 115,000 rubles.

Obviously, it is not possible to buy a registration certificate for a medical device. If you are interested in a detailed description of all the components of the total cost of a registration certificate for medical devices, you can read our article. There we discuss in detail what constitutes the cost of a registration certificate for a medical device received under the national rules.

If you want to find out the exact current cost of the registration certificate for your product, leave a request on the website or contact us. We will calculate the cost of each item of expenditure as soon as possible and prepare a detailed description of the registration procedure for your product.

Fines and other liabilities for violations related to the registration certificate

The main purpose of state control in the sphere of medical devices circulation is to verify that the subjects of circulation comply with the mandatory requirements established by regulatory acts. State control can take the following forms:

  • scheduled inspection;

  • unscheduled inspection;

  • control purchases.

The order of arrangement and conduction of state control of the quality and safety of medical activities is defined in the Regulation on state monitoring of the quality and safety of medical activities (established by the Decree of the Government of the Russian Federation No. 1152 dated November 12, 2012).

Violations detected in the framework of the state control can give occasion to bringing the perpetrators to administrative and even criminal responsibility!

Types of liability for violations related to receiving a registration certificate in Russia

wdt_ID Law violation Liability Article of the normative act which establishes liability Note
1 Violation of the established rules in the sphere of medical devices circulation, if these actions do not involve signs of a criminal offense Entails the imposition of an administrative fine on citizens in the amount of 2,000 to 4,000 rubles; on officials - from 5,000 to 10,000 rubles; on legal entities - from 30,000 to 50,000 rubles Article 6.28. of the Code of the Russian Federation on administrative offences This violation is the most widespread and includes many possible cases that occur with the subjects of medical devices circulation. From late changes to the registration dossier up to the failure to notify the regulator, for instance, about the change of the authorized representative. For final users it can be the use of a medical device without a RC
2 Manufacture, sale or import of falsified medical devices, or distribution or importation into the territory of the Russian Federation of counterfeit medical devices, if these actions do not involve signs of a criminal offense Entails the imposition of an administrative fine on citizens in the amount of 70,000 to 100,000 rubles; on officials - from 100,000 to 600,000 rubles; on individual entrepreneurs - from 100,000 to 600,000 rubles, or administrative suspension of activities for up to 90 days; on legal entities - from 1,000,000 to 5,000,000 rubles, or administrative suspension of activities for up to 90 days Article 6.33. of the Code of the Russian Federation on administrative offences
3 Sale or import into the territory of the Russian Federation of faulty medical devices, if these actions do not involve signs of a criminal offense Entails the imposition of an administrative fine on citizens in the amount of 70,000 to 100,000 rubles; on officials - from 100,000 to 600,000 rubles; on individual entrepreneurs - from 100,000 to 600,000 rubles, or administrative suspension of activities for up to 90 days; on legal entities - from 1,000,000 to 5,000,000 rubles, or administrative suspension of activities for up to 90 days Article 6.33. of the Code of the Russian Federation on administrative offences A faulty medical device is a product that does not meet the requirements of the regulatory, technical and (or) operational documentation of the manufacturer (producer) or, if the documentation is not available, the requirements of other regulatory documents. Therefore, the competence and experience of the experts who prepare your documentation affects the probability of emergence of grounds for initiating a case for this offense
4 Manufacture of medical devices without a license Entails imprisonment for a period of 3 to 5 years with a fine of 500,000 to 2,000,000 rubles or in the amount of the salary or other income of the convicted person during the period of 6 months up to 2 years or without it. The same acts committed: a) by an organized group; b) on a large scale (the value of more than 100,000 rubles) are punished by imprisonment for a period of 5 to 8 years with a fine of 1,000,000 to 3,000,000 rubles or in the amount of the salary or other income of the convicted person during the period of 1 to 3 years or without it Article 235.1. of the Criminal code of the Russian Federation One should receive a license for the manufacture and maintenance of medical equipment BEFORE the start of serial production of the medical device, but AFTER receiving the registration certificate. The availability of RC confirms that the manufacturer is prepared for the mass production of the device that meets all specified requirements
5 Manufacture for the purpose of use or sale, or use of admittedly forged documents for medical devices (registration certificate, certificate or declaration of conformity, regulatory, technical and operational documentation from the manufacturer (producer) of the medical device) Entails the punishment by a fine in the amount of 500,000 to 1,000,000 rubles or in the amount of the salary or other income of the convicted person during the period of 1 to 2 years, or by forced labor for a period of up to 3 years, or by imprisonment for the same period Article 327.2. of the Criminal code of the Russian Federation Therefore, preparation of documents for the purposes of receiving an RC should be entrusted to the professionals. Otherwise, the inconsistencies in the regulatory, technical and operational documents made during their preparation can be interpreted as grounds for bringing to responsibility under this article
6

Manufacture for use or sale or use of admittedly forged documents for medical devices (registration certificate, certificate or declaration of conformity, regulatory, technical and operational documentation from the manufacturer (producer) of the medical device)

The act was committed by an organized group

Entails imprisonment for a period of 5 to 10 years with deprivation of the right to hold certain positions or engage in certain activities for a period of up to 3 years Article 327.2. of the Criminal code of the Russian Federation Therefore, preparation of documents for the purposes of receiving an RC should be entrusted to the professionals. Otherwise, the inconsistencies in the regulatory, technical and operational documents made during their preparation can be interpreted as grounds for bringing to responsibility under this article
7 Manufacture, sale or import of falsified medical products, or distribution or importation into the territory of the Russian Federation of faulty medical devices, or illegal manufacture, sale, or importation into the territory of the Russian Federation for the purpose of sale of unregistered medical devices. The act was committed in large scale (over 100 000 rubles) Entails a punishment by forced labor for a period of 3 to 5 years with or without deprivation of the right to hold certain positions or engage in certain activities for a period of up to 3 years, or by imprisonment for a period of 3 to 5 years with a fine of 500,000 to 2,000,000 rubles, or in the amount of the salary or other income of the convicted person during the period of 6 months to 2 years, and with or without deprivation of the right to hold certain positions or engage in certain activities for a period of up to 3 years Article 238.1. of the Criminal code of the Russian Federation A faulty medical device is a product that does not meet the requirements of the regulatory, technical and (or) operational documentation of the manufacturer (producer) or, if the documentation is not available, the requirements of other regulatory documents. Therefore, the competence and experience of the experts who prepare your documentation affects the probability of emergence of grounds for initiating a case for this offense
8

Manufacture, sale or import of falsified medical devices, or distribution or importation into the territory of the Russian Federation of faulty medical devices, or illegal manufacture, sale or import into the territory of the Russian Federation for the purposes of sale of unregistered medical devices. The act was committed in large scale (over 100 000 rubles).

Refers to the acts that: a) were committed by a group of persons by prior agreement or by an organized group; b) caused serious injury or a person's death by negligence

Entails punishment by imprisonment for a period of 5 to 8 years with a fine in the amount of 1,000,000 to 3,000,000 rubles or in the amount of the salary or other income of the convicted person during the period of 1 to 3 years or without it and with deprivation of the right to hold certain positions or engage in certain activities for a period of up to 5 years or without it Article 238.1. of the Criminal code of the Russian Federation A faulty medical device is a product that does not meet the requirements of the regulatory, technical and (or) operational documentation of the manufacturer (producer) or, if the documentation is not available, the requirements of other regulatory documents. Therefore, the competence and experience of the experts who prepare your documentation affects the probability of emergence of grounds for initiating a case for this offense
9

Manufacture, sale or import of falsified medical devices, or distribution or importation into the territory of the Russian Federation of faulty medical devices, or illegal manufacture, sale or import into the territory of the Russian Federation for the purposes of sale of unregistered medical devices. The act was committed in large scale (over 100 000 rubles).

Refers to the acts that caused death of two or more persons

Entails punishment by imprisonment for a period of 8 to 12 years with a fine in the amount of 2,000,000 to 5,000,000 rubles or in the amount of the salary or other income of the convicted person during the period of 2 to 5 years or without it and with deprivation of the right to hold certain positions or engage in certain activities for a period of up to 10 years or without it Article 238.1. of the Criminal code of the Russian Federation A faulty medical device is a product that does not meet the requirements of the regulatory, technical and (or) operational documentation of the manufacturer (producer) or, if the documentation is not available, the requirements of other regulatory documents. Therefore, the competence and experience of the experts who prepare your documentation affects the probability of emergence of grounds for initiating a case for this offense

More information on the liabilities for violations of legislation in the field of medical devices with examples of law enforcement practice is given in this article .

Conclusion

As the data in the article shows, receiving a registration certificate for a medical device requires special knowledge of many aspects of their circulation, as well as experience in performing this type of work.

Arranging laboratory tests and interacting with Roszdravnadzor and its expert organizations also requires specialized skills and competencies. Our company’s experts have extensive experience of such work and are ready to assist you, both by carrying out individual stages of receiving a RC, and by taking care of all the concerns while providing services for registration of the RC.

You may also be interested: