Medical Device Registration Dossier Amendments in Russia
Medical Device Registration Dossier Amendments, known as VIRD, are carried out in accordance with the Rules for State Registration of Medical Devices, approved by Government Resolution No. 1684 of November 30, 2024. The procedure for amending the registration dossier (VIRD) is required for any modifications to the device’s design, composition, manufacturing technology, or intended purpose.
Medical devices marketed in the Russian Federation must fully comply with their official Registration Certificate or the relevant State Registry Entry. Failure to do so constitutes a breach of Articles 6.28 and 6.33 of the Code of Administrative Offenses and Article 238.1 of the Criminal Code of the Russian Federation, which govern the sale of substandard and counterfeit medical products. This exposes the responsible entity to significant legal and financial risks, including mandatory suspension of commercial activities, substantial fines, and potential criminal liability.
Registration Dossier Amendments (VIRD) ensures your product’s official documentation always matches the device on the market, maintaining legal compliance.
Based on Clauses 111-118 and 119-133 of the Rules, there are two distinct VIRD pathways, determined by the nature of the change:
- Registration Dossier Amendments (VIRD) WITHOUT expert examination of the medical device’s quality, efficacy, and safety;
- Registration Dossier Amendments (VIRD) WITH expert examination of the medical device’s quality, efficacy, and safety.
Amendments not requiring expert examination include:
a) Updating validity periods of documents in the registration dossier;
b) Changes made by manufacturers of Risk Class 1 devices or non-sterile Risk Class 2a devices that have passed quality management system assessment including design and development processes;
c) Changes to manufacturer information, including:
- Legal entity reorganization;
- Changes in legal entity name(s) and/or address;
- Changes to individual entrepreneur’s personal details, address, or passport details;
- Changes to production site address(es) due to renaming of geographical objects, streets, or changes in numbering/postal code.
d) Changes to Authorized Representative information, including:
- Legal entity reorganization;
- Changes in legal entity name(s) and/or address;
- Changes to individual entrepreneur’s personal details, address, or passport details.
e) Changes to medical device name concerning trademarks and other identification means;
f) Removal of device model(s) from the registry entry;
g) Changes to labeling design without altering symbols used;
h) Changes to classifier code due to new classifier version publication.
- Document Collection & Analysis: Gathering and preliminary review of all existing and updated documents provided by the manufacturer/AR
- Registration Dossier Preparation: Drafting missing documents and adapting submitted files to Russian requirements (if necessary)
- Submission & Fees: Electronic submission of the application and supporting documents to Roszdravnadzor via the Government Services Portal, including payment of state duties
- Formal Review: Roszdravnadzor’s check for completeness and accuracy
- Deficiency Response: Professional preparation and timely submission of responses to any queries or deficiencies identified by Roszdravnadzor (if necessary)
- Registry Update: The official entry of amendments into the Russian State Register of Medical Devices
Amendments requiring expert examination of the quality, efficacy, and safety of the medical device
In this case, medical device registration dossier documents amendments are required when changes need to be made to the registration documentation package, provided these changes do not affect the information stated in the Registration Certificate/Registry Entry.
Such changes include:
- Design or configuration changes;
- Addition/relocation of production sites;
- Use of new materials (dyes, change of material supplier);
- Addition of new device models;
- Changes to medical device packaging, etc.
- Document Collection & Analysis: Gathering and preliminary review of all existing and updated documents provided by the manufacturer/AR
- Registration Dossier Preparation: Drafting missing documents and adapting submitted files to Russian requirements (if necessary)
- Testing Strategy & Planning: Evaluation of required sample quantities and budgeting for all necessary tests (technical, toxicological, clinical)
- Lab & Clinical Site Selection: Identifying and contracting with accredited Russian test labs and clinical centers. Managing invoicing and agreements
- Import Sample of MD: Organizing customs clearance and delivery of test samples to Russian territory (for foreign manufacturers)
- Testing Management & Oversight: Full coordination and supervision of all required laboratory tests and trials of device samples
- Production Site Audit Management: Organization and support during the mandatory Quality Management System (QMS) inspection of the manufacturing facility (if required by risk class)
- Submission & Fees: Electronic submission of the application and supporting documents to Roszdravnadzor via the Government Services Portal, including payment of state duties
- Formal Review: Roszdravnadzor’s check for completeness and accuracy
- Deficiency Response: Professional preparation and timely submission of responses to any queries or deficiencies identified by Roszdravnadzor (if necessary)
- Expert Assessment & Examination: Guiding the dossier through the expert assessment for quality, efficacy, and safety by the expert institution (VNIIIMT or the National Institute of Quality)
- Final Deficiency Response: Addressing any final remarks to secure a positive conclusion (if necessary)
- Registry Update: The official entry of amendments into the Russian State Register of Medical Devices
a) Changes affecting functional purpose and/or principle of action;
b) Adding new device models that do not meet the criteria for grouping under a single registration under Government Resolution No. 1684 of November 30, 2024;
c) Simultaneous changes to both the manufacturer and the production site(s), with specific legal exceptions for administrative updates (e.g., legal form, address).
Estimated Timelines for Medical Device Registration Dossier Amendments in Russia:
| Registration Dossier Amendments (VIRD) WITHOUT expert examination |
from 3 months |
| Registration Dossier Amendments (VIRD) WITH expert examination |
from 8 months |
Official State Duty for Medical Device Registration Dossier Amendments in Russia (Registration Certificate Issuance with Amendments):
About $31 (applies to all risk classes)
Official State Fees for Medical Device Registration Dossier Amendment in Russia (Dossier Expertise):
| Risk Class 1 |
about $395 |
| Risk Class 2a |
about $590 |
| Risk Class 2b |
about $785 |
| Risk Class 3 |
about $1 275 |
Our Service Fees for Medical Device Registration Dossier Amendment in Russia:
| Registration Dossier Amendments (VIRD) WITHOUT expert examination |
from $860 |
| Registration Dossier Amendments (VIRD) WITH expert examination |
from $1 840 |
Medical Device Registration Dossier Amendments in EAEU
Medical Device Registration Dossier Amendments in EAEU (commonly referred to as VIRD) is mandatory for changes to a legally marketed device. A key obligation is the 90-calendar day deadline for the applicant to initiate the official amendment process after implementing the change.
a) Changes affecting functional purpose and/or principle of action;
b) Adding new models that do not meet the criteria for grouping under the existing registration certificate;
c) Simultaneous changes to both the manufacturer and the production site(s), with specific legal exceptions for administrative updates (e.g., legal form, address).
If amendments to the registration dossier result in changes to the operational documentation, Instructions for Use (IFU), service manual, or labeling text, a 180-calendar day transition period applies from the date these changes are approved.
During this period:
- It is permitted to release medical devices that correspond to the pre-amendment version of the dossier documentation;
- Simultaneous release of devices with both the old and new versions of the accompanying documentation and labeling is also allowed.
- Document Collection & Analysis: Gathering and preliminary review of all documents provided by the manufacturer/AR to reflect the change
- Registration Dossier Preparation: Drafting missing documents and adapting submitted files to Russian requirements, reflecting the changes
- Testing Strategy & Planning: Evaluation of required sample quantities and budgeting for all necessary tests (technical, toxicological, clinical)
- Lab & Clinical Site Selection: Identifying and contracting with accredited EAEU test labs and clinical centers. Managing invoicing and agreements
- Sample of MD: Manufacturing and/or importation of medical device samples into the territory of the EAEU member state where the testing will be conducted
- Testing Management & Oversight: Full coordination and supervision of all required laboratory tests and trials of device samples
- Submission & Fees: Filing the amendment application and updated dossier with the RMS authority (e.g., Roszdravnadzor for Russia as RMS), including payment of duties
- RMS Verification: The RMS authority’s check for completeness and accuracy
- Deficiency Response: Professional preparation and timely submission of responses to any queries or deficiencies identified by the RMS authority (if necessary)
- RMS Expert Assessment & Examination: Guiding the dossier through the expert assessment for quality, efficacy, and safety by RMS authority
- Final Deficiency Response: Addressing any final remarks to secure a positive conclusion (if necessary)
- Certificate Issuance without Recognizing Member State(s): Issuance of reissued EAEU Registration Certificate (if no Recognizing Member State(s))
- Recognition Procedure: Payment of recognition procedures for recognition of the RMS expert conclusion by Recognizing Member States, Recognition of the expert conclusion by authorized bodies (expert organizations) of Recognizing Member States
- Certificate Issuance: Upon approval from all concerned Recognizing Member States, a reissued EAEU Registration Certificate reflecting the changes is issued
Official Fees for Medical Device Registration Dossier Amendments in EAEU (Russia as RMS) – Dossier Expertise:
| Risk Class 1 |
about $395 |
| Risk Class 2a |
about $590 |
| Risk Class 2b |
about $785 |
| Risk Class 3 |
about $1 275 |
Medical Device Registration Dossier Amendments in the EAEU require additional fees in each Recognizing Member State.
Estimated Timelines for Medical Device Registration Dossier Amendments in EAEU:
12-20 months, highly dependent on the complexity of changes and the need for new testing
Our Service Fees for Medical Device Registration Dossier Amendment in EAEU:
From $3 680 (depends on change scope)
