Resultat-Audit supports amendments to medical-device registration dossiers where an expert review is required:

Amendments to the registration dossier and Registration Certificate may be required when, after registration, information relating to the product, manufacturer, documentation, composition, design, configuration, manufacturing process or conditions of use changes.

In 2026, the procedure is governed by RF Government Resolution No. 1684 dated 30 November 2024, “On Approval of the Rules for State Registration of Medical Devices.” This Resolution replaced the previous national-registration framework and establishes the current procedure for amending documents included in the registration dossier.

analyze the nature of the proposed changes

prepare the required document package

organize the necessary testing

support the procedure through the final decision of the registration authority

When are amendments requiring expert review necessary?

Expert review is required where new information may affect the safety, quality or effectiveness of the medical device. In such cases, simply updating administrative data is insufficient; it must be demonstrated that the device continues to meet all applicable requirements after the changes are implemented.

The applicable procedure depends not on the label given to the change, but on its impact on the device characteristics. If the change affects the intended purpose or operating principle, a new state registration rather than an amendment procedure may be required.

Changes that may require expert review include:

changes to the medical-device design.
changes to composition, configuration or materials.
addition of variants, sizes or configurations.
changes to the manufacturing site or manufacturing process.
changes to technical or operating documentation.
packaging changes that may affect sterility, shelf life, storage safety or transportation safety.
changes to information affecting the use of the medical device.

Which changes can be made without a new registration?

Changes that do not result in a different medical device may be considered within the scope of an existing Registration Certificate.

Each change must still be assessed. Even where a change appears purely technical or editorial, the registration authority may request supporting materials if the change could affect device safety, quality or effectiveness.

Such changes may include:

changes to applicant or manufacturer information.
changes to authorized-representative information.
updates to technical or operating documentation.
changes to labeling and packaging.
changes to configuration or accessories.
addition or removal of individual variants.
changes to manufacturing-site information.
updates to documents included in the registration dossier

When is a new registration required?

Amending an existing Registration Certificate is not always possible. A new registration may be required where the changes effectively turn the product into a different regulated medical device.

Attempting to process such changes as ordinary dossier amendments may result in refusal, additional requests or the need for resubmission.

Examples include:

change in intended purpose.
change in principle of operation.
substantial change in characteristics affecting safety or effectiveness.
changes to the design or composition such that the device no longer corresponds to the previously registered product.
expansion of the scope of use without sufficient evidence of safety and effectiveness.

Cost of amending the registration dossier

Support may include:

The service fee is calculated individually. The final price depends:

State fees, testing and other external costs are calculated separately.

Procedure Stages

1. Collection and analysis of documentation

We obtain the registration materials from the manufacturer or authorized representative and review the current Registration Certificate, registration dossier and technical and operating documentation. We assess the nature of the proposed changes and their potential impact on safety, quality, effectiveness, design, composition, manufacturing or conditions of use.

2. Determination of the applicable procedure

We determine whether the changes may be made within the existing registration dossier or whether a new registration is required. We determine whether an expert review of quality, effectiveness and safety is necessary and define the regulatory position and document list.

3. Revision of the registration dossier

We update technical and operating documentation, specifications, design descriptions, composition and configuration information, manufacturing information, labeling and packaging. Documents are revised to comply with RF Government Resolution No. 1684 and to remain consistent with previously registered information.

4. Testing program and sample size

We determine whether additional testing or studies are required and establish the required number of samples based on the risk class, device type and nature of the changes. Where necessary, we prepare the test program and laboratory documentation.

5. Organization of testing in an accredited laboratory

We organize the required testing in laboratories appropriate to the device profile. Testing may be required to confirm safety, effectiveness, technical characteristics, toxicological safety, electromagnetic compatibility or other parameters.

7. Testing and receipt of reports

We oversee the testing process and receipt of reports, verifying that the results correspond to the declared device characteristics and are suitable for inclusion in the registration dossier.

8. Manufacturing-site inspection, where required

If the nature of the changes requires assessment of the manufacturing site or process, we support preparation for inspection and review quality-management-system documentation, manufacturing information, quality-control processes and manufacturing-site data.

9. State fee and application preparation

We prepare the amendment application and submission package, verify the package structure and accuracy of the information, and assist with payment of the state fee where required.

10. Submission and registration-authority review

Documents are submitted through the established electronic procedure. The authority reviews completeness and accuracy. If comments are issued, we prepare revisions and correct the document package for resubmission. Roszdravnadzor states that amendment applications are submitted through the applicant’s unified account on the Gosuslugi public-services portal.

11. Expert review

The expert organization reviews the registration dossier, test results, technical and operating documentation, justification for the changes and their impact on safety, quality and effectiveness. If requests are issued, we prepare explanations, additional documents and substantiations.

12. Decision and implementation of amendments

Following a positive expert-review result, the registration authority decides to implement the amendments. The registration documents and register entry are updated; where required, an updated Registration Certificate or annex is issued.

6. Preparation and import of samples

For foreign-made devices, we support preparation of documents for importing samples into the Russian Federation and prepare the accompanying materials required for laboratory testing.

Document package for registration-dossier amendments

The composition of the package depends on the nature of the changes and whether expert review is required.

For a particular device, the final list is determined after analyzing the Registration Certificate, registration dossier and proposed changes.

The basic package typically includes:

• application for amendments.
• documents confirming the authority of the applicant or representative.
• current Registration Certificate and its annex.
• documents substantiating the proposed changes.
• updated technical documentation.
• updated operating documentation.
• updated labeling and packaging layouts.
• manufacturer and manufacturing-site information.
• test reports, where required.
• justification of the impact of the changes on safety, quality and effectiveness.
• documents confirming payment of the state fee.

Typical errors when making amendments

Such errors extend the procedure and may result in refusal to implement the amendments.

In practice, delays most often arise from:

• incorrect assessment of the nature of the changes.
• attempting to process changes that actually require a new registration.
• inconsistencies between technical documentation, instructions, labeling and test reports.
• lack of justification regarding the impact on safety and effectiveness.
• incomplete document package.
• incorrectly prepared testing documentation.
• failure to prepare for requests from the expert organization.

Why clients choose Resultat-Audit

This approach reduces the risk of refusal, repeated rework and unnecessary testing.

What we do:

We manage amendments not as a formal document-submission exercise but as a full regulatory project.

organize the required testing.
support interaction with Roszdravnadzor.
manage the procedure through the final decision.

analyze the changes before submission.
determine whether expert review is required.
prepare and revise the registration dossier.

Order registration-dossier amendments requiring expert review

To assess the timeline and cost, the current Registration Certificate, composition of the registration dossier and list of proposed changes must be reviewed.

Resultat-Audit will prepare an individual work plan, determine whether expert review is required and compile the document package for submission to the registration authority.

Still have questions?

Submit a request and we will call you back within one hour, review your case and propose a solution.

Companies

Services for obtaining medical device Registration Certificates and preparing medical device documentation. We work in accordance with EAEU rules and Roszdravnadzor requirements.

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