25 February 2026

Amending the Registration Dossier of a Medical Device under the Russian National Procedure

February 25, 2026

BRACE Law Firm©

During the operation and manufacture of medical devices, situations arise that require amendments or supplements to the registration dossier. Amending documents in the medical device registration dossier is an administrative procedure that proceeds through specific stages. The procedure depends on the framework under which the medical device was initially registered: under the national rules of the Russian Federation or under EAEU rules.

This article examines in detail the process of amending a registration dossier under the Russian national procedure.

What Does the Registration Dossier of a Medical Device Include?

Before examining this topic, we will outline the components of a medical device registration dossier.

A registration dossier is a set of documents submitted by an applicant for the state registration of a medical device. It includes technical and operational documentation, test materials, quality system documents, and other documentation. In particular, the registration dossier includes the following documents:

registration application;
information about the applicant and the manufacturer, and about the authorized representative of the manufacturer (the "Authorized Representative"), as well as a power of attorney for the Authorized Representative (if necessary);
technical documentation (information on the regulatory documentation for the medical device, technical and operational documentation, color photographs of the medical device, and images of the labeling and packaging);
test materials (protocols of technical tests, toxicological studies, and other evidentiary materials);
a draft description of the type of measuring instrument and the verification methodology (for medical devices classified as measuring instruments);
documents on clinical trials;
a clinical monitoring plan (for class 3 potential risk medical devices, as well as class 2b potential risk medical devices implanted into the human body);
documents confirming the right of the manufacturer to use a trademark and other means of individualization of the medical device (if they are applied to the packaging of the medical device);
documents on the expertise of the quality, efficiency, and safety of the medical device (assignment for the expertise, expertise conclusions, applicant's objections, and decisions of the regulatory body based on the results of the consideration of the applicant's objections to the conclusion);
copies of inspection reports for the production of the medical device;
copies of orders and notifications of the regulatory body adopted during the registration procedure.

The manufacturer of the medical device must maintain the registration dossier in an up-to-date state. When data included in the registration dossier changes, the new information must be provided to the regulatory body to amend the registration dossier. Roszdravnadzor (Federal Service for Surveillance in Healthcare) verifies the performance of this duty during the control over the circulation of medical devices conducted in accordance with Government Decree No. 1066 dated June 30, 2021.[1]

What Regulates Amendments to the Registration Dossier under the Russian National Procedure?

The procedure for making amendments to the registration dossier of a medical device under the national procedure is regulated by Chapters V – VI of the Rules for the State Registration of Medical Devices approved by Decree of the Government of the Russian Federation No. 1684 dated November 30, 2024 (the "Registration Rules"), (the "Decree No. 1684"). The terms and sequence of the administrative procedures of the regulatory body are established by the Administrative Regulations on the Provision of the State Service for the State Registration of Medical Devices approved by Roszdravnadzor Order No. 3371 dated May 6, 2019.

Additionally, in cases where a medical device was registered under an accelerated (simplified) procedure, the specific features of the Amendments to the Registration Dossier may be provided for by the Government Decrees under which such registration was carried out. We will also consider these features below.

The regulatory body, the Federal Service for Surveillance in Healthcare (Roszdravnadzor), carries out the amendments.

The Registration Rules distinguish between:

Amendments to the Registration Dossier without an expertise of the quality, efficiency, and safety of the medical device;
Amendments to the Registration Dossier with an expertise of the quality, efficiency, and safety of the medical device.

State Duty for Amending the Registration Dossier of a Medical Device

The amount of the state duty for performing such actions is determined by Article 333.32.2 of the Tax Code of the Russian Federation:

for making amendments to the documents contained in the registration dossier of a medical device that do not require an expertise of the quality, efficiency, and safety of the medical device—2,500 rubles;
for conducting an expertise of the quality, efficiency, and safety when making amendments to the documents contained in the registration dossier of a medical device, depending on the potential risk class of the medical device:
- class 1 — 32,000 rubles;
- class 2a — 48,000 rubles;
- class 2b — 64,000 rubles;
- class 3 — 104,000 rubles.

Amendments to the Registration Dossier without an Expertise of the Quality, Efficiency, and Safety of the Medical Device

According to paragraph 111 of Decree No. 1684, changes to the registration dossier without an expertise of the quality, efficiency, and safety of the medical device can be made in the following cases:

change of information about the manufacturer of the medical device, including information:
- on the reorganization of the legal entity;
- on the change of the names of the legal entity (full and abbreviated (if any), including the trade name) and its registered office address;
- on the change of the full name and residential address of an individual entrepreneur, and the details of their identity document;
- on the change of the address of the production site, if the change is caused by the renaming of a geographical object, street, square, or other territory, or a change in the numbering of addressing objects;
change of information about the authorized representative of the manufacturer, including information:
- on the reorganization of the legal entity;
- on the change of the name of the legal entity and its registered office address;
- on the change of the full name and address of an individual entrepreneur, and the details of their identity document;
change of the name of the medical device regarding the trademark and other means of individualization;
exclusion of information about the model (brand) of the medical device from the registry entry;
change of the labeling design without changing the symbols used in the labeling of the medical device;
changes to potential risk class 1 or non-sterile class 2a medical devices that have passed a production inspection.
- If the validity period of the production inspection report has expired, amendments are made with an expertise of the quality, efficiency, and safety.
change of the classifier code in the event of the release of a new edition of the classifier after the decision on state registration has been made.
change of the validity periods of the documents contained in the registration dossier.

To make amendments, the applicant shall submit to Roszdravnadzor no later than 90 business days the following set of documents:

an application containing information about the amendments;
copies of documents confirming the powers of the authorized representative of the manufacturer (mandatory for foreign manufacturers; submitted by domestic manufacturers if an authorized representative is present);
documents that have undergone corresponding changes and testify that the introduction of amendments:
1. does not entail a change in the properties and characteristics of the medical device affecting its safety, quality, and efficiency;
2. improves its properties and characteristics while maintaining the functional purpose and (or) principle of operation of the medical device;
copies of reports on the results of the production inspection (when changing the potential risk class).

Documents are submitted through the applicant's personal account on the Unified Portal of State and Municipal Services (Gosuslugi).

The registration period for amendments is no more than 18 business days from the date of receipt of the application and the set of documents.

The terms and sequence of the administrative procedures of the regulatory body are established by the Administrative Regulations on the Provision of the State Service for the State Registration of Medical Devices (the "Regulations").[2]

1. Verification of the completeness and reliability of the contained information.

After receiving the application, Roszdravnadzor conducts a verification of the completeness and reliability of the provided information within 5 business days.

If the documents are not submitted in full, the regulatory body notifies the applicant of the need to eliminate the identified violations through the applicant's personal account on the Gosuslugi portal. The period for eliminating deficiencies is 30 business days from the date of the notification. The elimination of identified violations is also carried out via the personal account. The time for eliminating violations is not included in the registration period.

If the violations are not eliminated within the specified period, the application is returned with the reasons for the return indicated.

2. Adoption of a decision to start the procedure for making amendments to the documents.

If the documents and information are submitted in full, the regulatory body adopts a decision to start the amendment procedure within 3 business days.

3. Adoption of a decision to amend the registration dossier.

Within 10 business days from the date of the decision to start the amendment procedure, Roszdravnadzor performs the following actions:

issues an order to amend the registration dossier;
sends a notification of the decision to the applicant's personal account;
amends the registry entry.

Amendments to the Registration Dossier Requiring an Expertise of the Quality, Efficiency, and Safety of the Medical Device

In cases not specified in paragraph 111 of Decree No. 1684, an expertise of the quality, efficiency, and safety is required to make amendments.

To start such a procedure, the applicant shall submit to Roszdravnadzor no later than 90 business days from the date of the change of the corresponding data the following documents:

an application containing information about the amendments;
copies of documents confirming the powers of the authorized representative of the manufacturer (mandatory for foreign manufacturers; submitted by domestic manufacturers if an authorized representative is present);
information on the results of clinical trials of the medical device (if applicable to this medical device);
documents confirming the existence of production conditions and (or) copies of certificates of conformity of the quality management system to the requirements of GOST ISO 13485-2017 or ISO 13485:2016;
copies of reports of previously conducted inspections for compliance with the specified standards;
documents confirming the compliance of the quality management system with the requirements for the implementation, maintenance, and evaluation of the quality management system for medical devices;
documents that have undergone corresponding changes and testify that the introduction of amendments:
- does not entail a change in the properties and characteristics of the medical device affecting its safety, quality, and efficiency;
- improves its properties and characteristics while maintaining the functional purpose and (or) principle of operation of the medical device.

Documents are submitted through the applicant's personal account on the Gosuslugi portal.

The registration period for amendments is no more than 36 business days from the date of receipt of the application and the set of documents.

Stages of Amending a Medical Device Registration Dossier under the Russian National Procedure

Stages of making amendments according to the Regulations:

1. Verification of the completeness and reliability of information.

Within 5 business days from the date of receipt of the application and documents, the regulatory body conducts a verification of the completeness and reliability of the information contained therein. The procedure for verification and elimination of violations is similar to the process for amendments without an expertise.

2. Adoption of a decision to start the procedure for making amendments to the documents.

If the documents and information are submitted in full, the regulatory body prepares and issues an assignment for conducting an expertise to an expert institution within 3 business days.

3. Conducting an expertise of the quality, efficiency, and safety of the medical device based on the assignment. The expertise is conducted within a period not exceeding 15 business days from the date the expert institution receives the corresponding assignment from the regulatory body.

Currently, the expertise is conducted by the FSBI "National Quality Institute" and the FSBI "All-Russian Scientific Research and Testing Institute of Medical Engineering". The procedure for conducting the expertise is similar to the procedure provided for the registration of a medical device.

It should be noted that the expert institution is not entitled to request additional documents and materials necessary for the expertise directly from the applicant. If the submitted information is found to be incomplete, a corresponding request is sent through Roszdravnadzor. The applicant must provide a response to the request of the regulatory body through the personal account within a period not exceeding 50 business days.

Based on the results of the expertise, the expert institution sends to the regulatory body a conclusion on the possibility of making amendments to the registration dossier documents or the impossibility of such amendments.

4. Evaluation of the expert institution's conclusion and adoption of a decision on making amendments or refusal.

Within 10 business days from the date of receipt of the expert conclusion, the regulatory body evaluates it.

A negative conclusion is posted in the applicant's personal account. The applicant has the right to submit objections to the conclusion within 10 business days. The regulatory body considers them within 30 business days from the date of receipt of the objections, involving the expert institution, and adopts a decision to recognize the objections as justified and send the conclusion for revision, or to refuse.

5. Adoption of a decision to amend the registration dossier or refusal.

Based on the results of the consideration of the conclusion, the regulatory body adopts a decision on the possibility (impossibility) of making amendments to the documents and sends a corresponding notification to the applicant's personal account. In the event of a positive decision, corresponding changes are also made to the registry entry.

The regulatory body may refuse to make amendments in the following cases:

receipt from the expert institution of a conclusion testifying to the impossibility of making amendments to the documents, and (or) adoption by the regulatory body of a decision to recognize the applicant's objections as unjustified;
identification of discrepancies between the data on the efficiency and safety of the medical device and the data on the medical device contained in the application and documents based on the results of federal state control (surveillance) over the circulation of medical devices.

Specific Features of Amending the Registration Dossier for Software Using Artificial Intelligence Technologies

Decree No. 1684 provides for specific features for amending the registration dossier for software using artificial intelligence technologies that is a medical device.

In particular, a simplified procedure is provided for making amendments to the numbering of versions (if they do not affect the functional purpose), provided that there is a built-in function for the automatic transfer of data on its operation to Roszdravnadzor. To do this, it is sufficient to send an application through the personal account indicating information about:

the name of the medical device;
the registration number and date of the state registration of the medical device;
information about the software version, the details of which must be entered into the state register;
the payment of the state duty (date and number of the payment order);
the applicant's responsibility for the reliability and identity of the information contained in the registration dossier and the application for amendments.

The period for considering such an application and making a decision on it is 5 business days.

Specific Features of Amending the Registration Dossier for Medical Devices with a Risk of Shortage

Government Decree No. 552 dated April 1, 2022[3] (the "Decree No. 552") establishes specific features for the Amendments to the Registration Dossier regarding medical devices for which a shortage or the risk of its occurrence has been established and which were registered under a simplified procedure (the "medical devices with a risk of shortage").

More details on which medical devices fall into this category can be found in our special article on this topic.[4]

Similarly to the general Registration Rules, Decree No. 1684 provides for 2 types of Amendments to the Registration Dossier:

1. If the introduction of amendments does not require an expertise of quality, efficiency, and safety.

The difference from the general registration rules for such amendments lies in the list of documents and the accelerated procedure. Roszdravnadzor adopts a decision to make amendments to the documents, or a refusal with a justification of the reasons for refusal, within 15 business days from the date of submission of the established set of documents.

2. If an expertise of the quality, efficiency, and safety of the medical device is required.

In such a case, the Amendments to the Registration Dossier are carried out in the manner provided for by the Registration Rules. However, a reduced period is established for registration actions compared to Decree No. 1684—25 business days from the date of receipt of the application and documents.

Specific Features of the Registration of Domestically Produced Medical Devices

Regarding domestic medical devices, Decree No. 552 also establishes specific features for the Amendments to the Registration Dossier.

As a reminder, in accordance with paragraph 24 of the Registration Rules, domestic medical devices are those in respect of which two conditions are met:

the manufacturer is a Russian legal entity or an individual entrepreneur;
the manufacturer has its own production site on the territory of Russia.

These specific features apply in cases where amendments are required for the following information:

information on purchased products, raw materials, materials, and components;
information on constituent parts, spare parts, and accessories.

If it is necessary to change the specified information, the applicant shall submit the following documents to the regulatory body through the personal account no later than 30 business days:

an application;
a copy of the document confirming the powers of the authorized representative of the manufacturer;
documents and information on the corresponding changes, including documents confirming that the introduction of these changes does not entail a change in the properties and characteristics of the medical device affecting its safety, quality, and efficiency, or improves its properties and characteristics while maintaining the functional purpose and principle of operation of the medical device;
documents on the results of technical tests, toxicological studies, and clinical trials.

The Amendments to the Registration Dossier for domestically produced medical devices in the specified cases are conducted within reduced timeframes. The expertise of quality, safety, and efficiency is conducted by the expert institution within 5 business days from the date of receipt of the assignment from the regulatory body. The decision to make amendments to the registration dossier and the registry entry is carried out by Roszdravnadzor within 7 business days from the date of receipt of a positive conclusion from the expert institution.

Specific Features of Amending the Registration Dossier for Medical Devices Intended for Use in Emergency Situations

Government Decree No. 430 dated April 3, 2020[5] establishes specific features for the registration of a series (batch) of medical devices that are intended for use in conditions of military operations, emergency situations, their prevention, and the prophylaxis and treatment of diseases that pose a danger to others, as well as diseases and injuries resulting from exposure to unfavorable chemical, biological, and radiation factors.

The list of such medical devices indicating the nomenclature code for medical devices (NKMI) is given in Appendix No. 1 to Decree No. 430 (the "List"). For them, a simplified registration procedure is established, involving the registration of individual series (batches) of the medical device, and accordingly, a simplified procedure for the Amendments to the Registration Dossier.

Regarding the medical devices specified in paragraphs 1 – 18 of the List, amendments to the name of the medical device are allowed in terms of information about its serial number, or series (batch) number, if other information in the registration dossier has not changed.

To make the specified amendments, the following must be provided to Roszdravnadzor:

an application;
a copy of the document confirming the powers of the authorized representative of the manufacturer;
documents confirming that the series (batch) of the medical device belongs to the applicant on legal grounds;
photographic images of the general appearance of the medical device;
a document from the manufacturer confirming that the medical device with the declared serial numbers or series (batch) numbers is identical to the medical device originally registered;
the original Registration Certificate.

The registration application is provided in the form of an electronic document and (or) on paper directly or sent by registered mail with a return receipt and an inventory of contents.

Within 3 business days from the date of receipt, Roszdravnadzor conducts a verification of the completeness and reliability of the information contained therein and adopts a decision to make amendments to the registration dossier and the registry entry, or to return the application with a reasoned justification of the reasons for the return. A notification is sent to the applicant by registered mail with the reissued Registration Certificate attached.

Liability for Failure to Amend the Registration Dossier

Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation prohibits the production and sale of unregistered, falsified, and substandard medical devices.

A falsified medical device is one accompanied by false information about its characteristics and (or) manufacturer. A substandard medical device is one that does not comply with the safety and efficiency requirements for medical devices, the requirements for their labeling, or the regulatory, technical, and operational documentation, and which cannot be safely used for its intended purpose as established by the manufacturer. The law does not disclose the concept of an unregistered medical device; an unregistered medical device is understood as one not entered into the state register. In particular, Roszdravnadzor also classifies as such medical devices that do not correspond to the set of registration documentation.

If it is identified that a medical device does not correspond to the registration dossier documents, Roszdravnadzor may send a letter to the medicinal product circulation entities regarding its withdrawal from circulation.

Thus, in Case No. A40-231506/16,[6] a company applied to the court to declare invalid an information letter from Roszdravnadzor on conducting measures to prevent the circulation on the territory of the Russian Federation of a falsified medical device "Biopsy Needles" from manufacturer B. As was established during the court proceedings, manufacturer B. ceased its activities due to bankruptcy in June 2012, but medical devices accompanied by information about manufacture after the specified date were in circulation on the territory of the Russian Federation. This served as the reason for Roszdravnadzor to send a letter on preventing the circulation of such a medical device.

The company engaged in the sale of this product claimed that these needles continued to be produced on the same production equipment using the same technology by company T., which had purchased the trademark rights. However, no application to amend the registration dossier had been submitted to Roszdravnadzor. The court concluded that the sale of a medical device actually produced by company T., labeled as the products of company B., evidenced the falsification of the medical device as being accompanied by false information about the manufacturer. The court denied the claim.

The manufacturer may also be held administratively or criminally liable.

Administrative liability is provided for by parts 1 and 2 of Article 6.33 of the CAO RF for the production, sale, or import into the territory of the Russian Federation of falsified and substandard medical devices, if these actions do not contain signs of a criminally punishable act. The punishment for officials is a fine of up to 600,000 rubles; for individual entrepreneurs—up to 600,000 rubles or administrative suspension of activity for up to 90 days; for legal entities—up to 5,000,000 rubles or administrative suspension of activity for up to 90 days.

Criminal liability is provided for by Article 238.1 of the Criminal Code of the Russian Federation for the production, sale, or import into the territory of the Russian Federation of falsified medical devices, or the sale or import into the territory of the Russian Federation of substandard medical devices, or the illegal production, sale, or import into the territory of the Russian Federation for the purpose of sale of unregistered medical devices on a large scale. A large scale is the value of medical devices in an amount exceeding 100,000 rubles.

The maximum penalty is deprivation of liberty for a term of up to 5 years with a fine in the amount of up to 2,000,000 rubles or in the amount of the salary for a period of up to 2 years and with deprivation of the right to occupy certain positions or engage in certain activities for a term of up to 3 years. In the presence of aggravating circumstances (committing a crime using the media or the Internet, by a group by prior conspiracy, resulting in death by negligence, etc.), the crime is punished more severely.

Let us illustrate this with an example from judicial practice. Thus, in Case No. 77-3590/2023,[7] R., holding the position of deputy general manager of a company, knowing about the conclusion of contracts by the company with medical institutions for the supply of X-ray apparatuses, organized the purchase of key components for such apparatuses from another manufacturer. Then, on his instructions, the factory labeling on the purchased components was replaced with the company's labeling stickers, and operating manuals and passports for the medical device were manufactured, the contents of which regarding the manufacturer, model, production time, technical specifications, and other characteristics did not correspond to the medical devices that were supplied to the treatment institutions. R. claimed that the fact of purchasing components for the production of X-ray apparatuses was not hidden, the manufactured apparatuses were of high quality, and the replacement of the marking plates on the parts was dictated by the need to fulfill technical documentation requirements.

The court concluded that the manufactured medical devices did not correspond to the registration dossier documents. The court found R. guilty of selling falsified medical devices and sentenced him to 3 years of deprivation of liberty; subsequently, the sentence was replaced by forced labor for a term of 3 years with a 10% deduction from earnings to the state.

In conclusion, we note that to avoid negative consequences, manufacturers and their authorized representatives must exercise constant control over the production of medical devices. In the event of any changes to the registration dossier documents, it is necessary to initiate the procedure for making amendments to the registration dossier in a timely manner. However, since the process of amending the registration dossier for a medical device is full of nuances, we recommend involving qualified specialists in this field to support this procedure.

References

[1] Government Decree No. 1066 dated June 30, 2021, On Federal State Control (Surveillance) over the Circulation of Medical Devices.

[2] Roszdravnadzor Order No. 3371 dated May 6, 2019, On the Approval of the Administrative Regulations of the Federal Service for Surveillance in Healthcare on the Provision of the State Service for the State Registration of Medical Devices.

[3] Decree of the Government of the Russian Federation No. 552 dated April 1, 2022, On the Approval of the Features of Circulation, Including the Specific Features of the State Registration, of Medical Devices in the Event of Their Shortage or the Risk of a Shortage Due to the Introduction of Restrictive Measures of an Economic Nature against the Russian Federation.

[4] See: https://brace-lf.com/informaciya/farmatsevticheskoe-i-meditsinskoe-pravo/registraciya-mi-pravila-rf

[5] Decree of the Government of the Russian Federation No. 430 dated April 3, 2020, On the Specific Features of the Circulation of Medical Devices, Including the State Registration of a Series (Batch) of a Medical Device.

[6] Resolution of the Arbitration Court of the Moscow District dated October 26, 2017, No. F05-15195/2017 in Case No. A40-231506/16.

[7] Resolution of the First Court of Cassation of General Jurisdiction dated July 25, 2023, No. 77-3590/2023.