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Russia medical device regulations

Official sources linked

Roszdravnadzor rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.

12 documents3 categories100% linked to official sourcesauthority Roszdravnadzor9 readable HTML
CodeRegulationCategoryEffectiveProvenance
Government Decree No. 1684
Rules for State Registration of Medical Devices
Current Russian rules for state registration of medical devices under Roszdravnadzor, including electronic submissions, review procedures, and registration-record requirements.
RegistrationMarch 1, 2025Official
Government Decree No. 1684 of 30 November 2024, amended through 3 August 2026
Rules for State Registration of Medical Devices — official government consolidation through 3 August 2026
Complete official Government of Russia HTML consolidation of the decree dated 30 November 2024, retained across all 10 published pages. Its heading lists amendments No. 1206/2025, No. 1670/2025, No. 2214/2025 and No. 974/2026. Registration and dossier-change provisions cover medical devices and IVDs. Individual commencement, expiry and transitional conditions remain applicable.
RegistrationMarch 1, 2025Official
EEC Council Decision No.46 of 12 February 2016
EAEU medical-device registration and examination rules — complete original 2016 decision and annexes
Complete seventy-five-page scanned original of EEC Council Decision No.46 of 12 February 2016 and its attached medical-device registration and examination rules and annexes. This historical original is a shared EAEU instrument preserved in the Russian market context; later amendments and any present-day consolidation must be assessed separately. All original page images are retained. Native search text may be empty; no OCR or reconstructed legal text is supplied. No current-law, universal corporate-change route or completed-question determination.
Registration—Official
Roszdravnadzor EAEU medical-device registration service standard
EAEU medical-device registration — complete official service standard
Complete twenty-six-page official service standard for the EAEU medical-device registration route administered by Roszdravnadzor. The national route is separate. Branch-specific document, timing and payment conditions remain in the original; none is promoted to a universal answer for the six change scenarios. No printed revision date is established here. Complete original page images govern; any native text remains a qualified, potentially incomplete search layer. No current-law, whole-country or completed-question determination.
Registration—Official
EEC Council Decision No.104 of 9 September 2026
EAEU medical-device registration rules — amendment to paragraph 114
Complete two-page official decision amending paragraph 114 of the EAEU medical-device registration and examination rules. This is a shared EAEU instrument hosted by Roszdravnadzor, retained for the Russian market context; it is not a Russia-only national procedure. Printed adoption and conditional commencement statements are preserved without computing a present-day effective date. Complete original page images govern; any native text remains a qualified, potentially incomplete search layer. No current-law, whole-country or completed-question determination.
Registration—Official
EEC Council Decision No.50 of 8 July 2025
EAEU medical-device registration rules — Decision 50/2025 and its amendment annex
Complete five-page scanned official decision and annex amending the EAEU medical-device registration and examination rules. The native PDF search layer is empty; no OCR or reconstructed text is supplied. This is a shared EAEU instrument, not a national registration route or an unconditional corporate-change permission. Complete original page images govern; any native text remains a qualified, potentially incomplete search layer. No current-law, whole-country or completed-question determination.
Registration—Official
Federal Law No. 323-FZ, Article 38
Legal Basis for Medical Device Circulation and Registration
Establishes that medical devices may circulate in Russia only after state registration and provides the legal basis for registry, licensing, and market-control functions.
General—Official
Federal Law No. 323-FZ, Article 96
Medical Device Safety Monitoring Requirements
Requires safety monitoring for medical devices in circulation to identify adverse reactions, unexpected interactions, and circumstances that may threaten patients or healthcare workers.
Vigilance—Official
Minzdrav Order No.181н of 11 April 2025
Manufacturer technical and operational documentation requirements — complete signed official publication
Complete twenty-one-page signed official publication of the manufacturer technical and operational documentation requirements for medical devices. Original page images are authoritative; the original PDF has no native searchable text. The separate RTF copy is a different expression of the instrument. Legal currentness and applicability to a particular change have not been determined.
Registration—Official
Roszdravnadzor national medical-device registration service standard
National medical-device registration — complete official service standard
Complete thirty-page official service standard for the Russian national medical-device registration service. It preserves the stated transaction branches, document requirements, phases and qualifications. No printed revision date is established here, and service-specific clocks or charges are not generalized to all manufacturer, holder or combined changes. This publication is distinct from the EAEU service standard. Complete original page images govern; any native text remains a qualified, potentially incomplete search layer. No current-law, whole-country or completed-question determination.
Registration—Official
Roszdravnadzor — Dossier changes requiring expertise
Changes to a medical-device registration dossier requiring expert assessment
Full official procedure body for changes requiring expert assessment, including application content, authorized-representative powers, manufacturing/QMS evidence, and submission documentation.
Registration—Official
Roszdravnadzor — Dossier changes without expertise
Changes to a medical-device registration dossier not requiring expert assessment
Full official procedure body classifying non-expertise changes, including legal-manufacturer identity/address and authorized-representative changes, and associated document requirements.
Registration—Official
Exports carry source + retrieval date

Changes after registration in Russia

Source-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval
  • Labels and identifiers

Trademark/name changes without expertise

Fact-level verified

Clause 111(д) includes changing the device name in respect of a trademark or other means of individualization among dossier changes not requiring quality, efficacy and safety expertise. Clause 111(ж) separately includes label-design changes without changing the symbols used on the device marking.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • The label-design condition does not establish that every logo/symbol change qualifies.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

  • Filing route and prior approval

Dossier-change submission deadline

Fact-level verified

For clause 111 non-expertise changes, clause 112 requires submission through the unified applicant cabinet no later than90 working days after the relevant data changed. Clause 120 provides the same filing deadline for clause 119 expertise changes.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • This90workingday period is an applicant filing deadline; it is not an authority review duration or an old-label sell-through period.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

  • Change-specific review time

Non-expertise statutory review period and excluded deficiency time

Fact-level verified

Clause 113 limits the non-expertise dossier-change procedure to 18 working days from receipt of the application and the documents required by clause 112. Clause 114 provides a five-working-day completeness/accuracy check; clause 117 provides a three-working-day start decision after the check or rectification; and clause 118 provides a ten-working-day decision/register-update phase after the start decision. Under clause 115, the interval from deficiency notification until receipt of the response or notice that no response was provided is excluded from the procedure time.

Conditions
  • National Russian registration under Decree 1684, only when the actual change qualifies for the clause 111 non-expertise route.
  • The 18-working-day limit is stated in clause 113, rather than inferred by adding the phases. Preparation before submission and the clause 115 excluded deficiency interval are not a guaranteed elapsed approval time.
  • The deficiency provisions allow 30 working days for rectification; failure to rectify can terminate consideration under clause 116.
  • This statutory clock supplies no empirical best/expected/worst forecast and proves no universal combined filing, single fee, stock grace period or unrelated-holder transfer route.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

  • Supporting documents

Evidence supporting dossier changes

Fact-level verified

Clause 112 requires the change application and describes supporting evidence including authorized-representative powers and confirmation that changes do not impair device safety/quality/efficacy or change intended purpose/principle of operation. Additional QMS documents are conditional on the specified low-risk/QMS route. Expertise-route documents are specified separately in clause 120.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • Use the actual clause111 or119 route and applicable document conditions.
  • This does not imply that a CFS, legalization or new QMS certificate is required for every administrative change.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Change control →Label, IFU & language →UDI, listing & traceability →

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Manufacturer name and office address changes

Fact-level verified

Clause 111(в) includes changes to the manufacturer legal-person name and address of location, and information about legal-person reorganization, among dossier changes not requiring quality, efficacy and safety expertise. It separately limits the production-site address case to administrative geographical/street/number/postcode changes.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • Distinguish the same legal manufacturer changing its name/office address from a real manufacturing-site move or a different manufacturer.
  • This listing alone does not prove combined brand/name/address filing permission.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

  • Filing route and prior approval

Dossier-change submission deadline

Fact-level verified

For clause 111 non-expertise changes, clause 112 requires submission through the unified applicant cabinet no later than90 working days after the relevant data changed. Clause 120 provides the same filing deadline for clause 119 expertise changes.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • This90workingday period is an applicant filing deadline; it is not an authority review duration or an old-label sell-through period.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

  • Change-specific review time

Non-expertise statutory review period and excluded deficiency time

Fact-level verified

Clause 113 limits the non-expertise dossier-change procedure to 18 working days from receipt of the application and the documents required by clause 112. Clause 114 provides a five-working-day completeness/accuracy check; clause 117 provides a three-working-day start decision after the check or rectification; and clause 118 provides a ten-working-day decision/register-update phase after the start decision. Under clause 115, the interval from deficiency notification until receipt of the response or notice that no response was provided is excluded from the procedure time.

Conditions
  • National Russian registration under Decree 1684, only when the actual change qualifies for the clause 111 non-expertise route.
  • The 18-working-day limit is stated in clause 113, rather than inferred by adding the phases. Preparation before submission and the clause 115 excluded deficiency interval are not a guaranteed elapsed approval time.
  • The deficiency provisions allow 30 working days for rectification; failure to rectify can terminate consideration under clause 116.
  • This statutory clock supplies no empirical best/expected/worst forecast and proves no universal combined filing, single fee, stock grace period or unrelated-holder transfer route.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

  • Supporting documents

Evidence supporting dossier changes

Fact-level verified

Clause 112 requires the change application and describes supporting evidence including authorized-representative powers and confirmation that changes do not impair device safety/quality/efficacy or change intended purpose/principle of operation. Additional QMS documents are conditional on the specified low-risk/QMS route. Expertise-route documents are specified separately in clause 120.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • Use the actual clause111 or119 route and applicable document conditions.
  • This does not imply that a CFS, legalization or new QMS certificate is required for every administrative change.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Change control →Economic-operator roles →Label, IFU & language →

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Manufacturer name and office address changes

Fact-level verified

Clause 111(в) includes changes to the manufacturer legal-person name and address of location, and information about legal-person reorganization, among dossier changes not requiring quality, efficacy and safety expertise. It separately limits the production-site address case to administrative geographical/street/number/postcode changes.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • Distinguish the same legal manufacturer changing its name/office address from a real manufacturing-site move or a different manufacturer.
  • This listing alone does not prove combined brand/name/address filing permission.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

  • Filing route and prior approval

Dossier-change submission deadline

Fact-level verified

For clause 111 non-expertise changes, clause 112 requires submission through the unified applicant cabinet no later than90 working days after the relevant data changed. Clause 120 provides the same filing deadline for clause 119 expertise changes.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • This90workingday period is an applicant filing deadline; it is not an authority review duration or an old-label sell-through period.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

  • Change-specific review time

Non-expertise statutory review period and excluded deficiency time

Fact-level verified

Clause 113 limits the non-expertise dossier-change procedure to 18 working days from receipt of the application and the documents required by clause 112. Clause 114 provides a five-working-day completeness/accuracy check; clause 117 provides a three-working-day start decision after the check or rectification; and clause 118 provides a ten-working-day decision/register-update phase after the start decision. Under clause 115, the interval from deficiency notification until receipt of the response or notice that no response was provided is excluded from the procedure time.

Conditions
  • National Russian registration under Decree 1684, only when the actual change qualifies for the clause 111 non-expertise route.
  • The 18-working-day limit is stated in clause 113, rather than inferred by adding the phases. Preparation before submission and the clause 115 excluded deficiency interval are not a guaranteed elapsed approval time.
  • The deficiency provisions allow 30 working days for rectification; failure to rectify can terminate consideration under clause 116.
  • This statutory clock supplies no empirical best/expected/worst forecast and proves no universal combined filing, single fee, stock grace period or unrelated-holder transfer route.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

  • Supporting documents

Evidence supporting dossier changes

Fact-level verified

Clause 112 requires the change application and describes supporting evidence including authorized-representative powers and confirmation that changes do not impair device safety/quality/efficacy or change intended purpose/principle of operation. Additional QMS documents are conditional on the specified low-risk/QMS route. Expertise-route documents are specified separately in clause 120.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • Use the actual clause111 or119 route and applicable document conditions.
  • This does not imply that a CFS, legalization or new QMS certificate is required for every administrative change.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Change control →Economic-operator roles →Label, IFU & language →

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Changes requiring a new device registration

Fact-level verified

Clause 110 requires registration of a new medical device for a change to its intended purpose or principle of operation; inclusion of model/make information that does not satisfy the grouping criteria in clause 26; or simultaneous changes to manufacturer and manufacturing-site information, subject to the express exceptions for legal form, address of location, reorganization and other constituent-document information.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • A commercial SMN/REF/order number is not automatically the registered model or make.
  • The stated simultaneous manufacturer/production-site rule does not establish that every name/office-address/brand combination requires new registration.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Conditions for this question

  • A commercial SMN/REF/order number is not automatically the registered model or brand.
  • A purely commercial SMN/REF/order-number change is not automatically a change to the registered model/make; identify the actual registered data field first.
  • Filing route and prior approval
  • Labels and identifiers

Removal of a registered model

Fact-level verified

Clause 111(е) includes removing information about a medical-device model (make) from the register entry among dossier changes not requiring quality, efficacy and safety expertise.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • Applies to removal of a registered model/make. Does not establish the treatment of a purely commercial REF/SMN code, addition of a model, or arbitrary renaming.
  • The clause changes registered model information; it does not itself require a particular label revision.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Conditions for this question

  • Applies to removal of a registered model/brand. Does not establish the treatment of a purely commercial REF/SMN code, addition of a model, or arbitrary renaming.
  • A purely commercial SMN/REF/order-number change is not automatically a change to the registered model/make; identify the actual registered data field first.
  • Filing route and prior approval

Dossier-change submission deadline

Fact-level verified

For clause 111 non-expertise changes, clause 112 requires submission through the unified applicant cabinet no later than90 working days after the relevant data changed. Clause 120 provides the same filing deadline for clause 119 expertise changes.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • This90workingday period is an applicant filing deadline; it is not an authority review duration or an old-label sell-through period.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Conditions for this question

  • A purely commercial SMN/REF/order-number change is not automatically a change to the registered model/make; identify the actual registered data field first.
  • Change-specific review time

Non-expertise statutory review period and excluded deficiency time

Fact-level verified

Clause 113 limits the non-expertise dossier-change procedure to 18 working days from receipt of the application and the documents required by clause 112. Clause 114 provides a five-working-day completeness/accuracy check; clause 117 provides a three-working-day start decision after the check or rectification; and clause 118 provides a ten-working-day decision/register-update phase after the start decision. Under clause 115, the interval from deficiency notification until receipt of the response or notice that no response was provided is excluded from the procedure time.

Conditions
  • National Russian registration under Decree 1684, only when the actual change qualifies for the clause 111 non-expertise route.
  • The 18-working-day limit is stated in clause 113, rather than inferred by adding the phases. Preparation before submission and the clause 115 excluded deficiency interval are not a guaranteed elapsed approval time.
  • The deficiency provisions allow 30 working days for rectification; failure to rectify can terminate consideration under clause 116.
  • This statutory clock supplies no empirical best/expected/worst forecast and proves no universal combined filing, single fee, stock grace period or unrelated-holder transfer route.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Conditions for this question

  • A purely commercial SMN/REF/order-number change is not automatically a change to the registered model/make; identify the actual registered data field first.
  • Supporting documents

Evidence supporting dossier changes

Fact-level verified

Clause 112 requires the change application and describes supporting evidence including authorized-representative powers and confirmation that changes do not impair device safety/quality/efficacy or change intended purpose/principle of operation. Additional QMS documents are conditional on the specified low-risk/QMS route. Expertise-route documents are specified separately in clause 120.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • Use the actual clause111 or119 route and applicable document conditions.
  • This does not imply that a CFS, legalization or new QMS certificate is required for every administrative change.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Conditions for this question

  • A purely commercial SMN/REF/order-number change is not automatically a change to the registered model/make; identify the actual registered data field first.
Change control →UDI, listing & traceability →Label, IFU & language →

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Changes requiring a new device registration

Fact-level verified

Clause 110 requires registration of a new medical device for a change to its intended purpose or principle of operation; inclusion of model/make information that does not satisfy the grouping criteria in clause 26; or simultaneous changes to manufacturer and manufacturing-site information, subject to the express exceptions for legal form, address of location, reorganization and other constituent-document information.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • A commercial SMN/REF/order number is not automatically the registered model or make.
  • The stated simultaneous manufacturer/production-site rule does not establish that every name/office-address/brand combination requires new registration.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Conditions for this question

  • A commercial SMN/REF/order number is not automatically the registered model or brand.
  • This evidence covers only the stated national dossier-change case. It does not establish transfer of a registration to an unrelated manufacturer/holder, recovery from a partner, or permission to combine every requested change in one filing.
  • Filing route and prior approval

Dossier-change submission deadline

Fact-level verified

For clause 111 non-expertise changes, clause 112 requires submission through the unified applicant cabinet no later than90 working days after the relevant data changed. Clause 120 provides the same filing deadline for clause 119 expertise changes.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • This90workingday period is an applicant filing deadline; it is not an authority review duration or an old-label sell-through period.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Conditions for this question

  • This evidence covers only the stated national dossier-change case. It does not establish transfer of a registration to an unrelated manufacturer/holder, recovery from a partner, or permission to combine every requested change in one filing.
  • Change-specific review time

Non-expertise statutory review period and excluded deficiency time

Fact-level verified

Clause 113 limits the non-expertise dossier-change procedure to 18 working days from receipt of the application and the documents required by clause 112. Clause 114 provides a five-working-day completeness/accuracy check; clause 117 provides a three-working-day start decision after the check or rectification; and clause 118 provides a ten-working-day decision/register-update phase after the start decision. Under clause 115, the interval from deficiency notification until receipt of the response or notice that no response was provided is excluded from the procedure time.

Conditions
  • National Russian registration under Decree 1684, only when the actual change qualifies for the clause 111 non-expertise route.
  • The 18-working-day limit is stated in clause 113, rather than inferred by adding the phases. Preparation before submission and the clause 115 excluded deficiency interval are not a guaranteed elapsed approval time.
  • The deficiency provisions allow 30 working days for rectification; failure to rectify can terminate consideration under clause 116.
  • This statutory clock supplies no empirical best/expected/worst forecast and proves no universal combined filing, single fee, stock grace period or unrelated-holder transfer route.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Conditions for this question

  • This evidence covers only the stated national dossier-change case. It does not establish transfer of a registration to an unrelated manufacturer/holder, recovery from a partner, or permission to combine every requested change in one filing.
  • Supporting documents

Evidence supporting dossier changes

Fact-level verified

Clause 112 requires the change application and describes supporting evidence including authorized-representative powers and confirmation that changes do not impair device safety/quality/efficacy or change intended purpose/principle of operation. Additional QMS documents are conditional on the specified low-risk/QMS route. Expertise-route documents are specified separately in clause 120.

Conditions
  • Apply only to a national Russian registration dossier under Decree1684.
  • A rule for one change does not establish a combined application, a single fee or a guaranteed total timeline.
  • Use the actual clause111 or119 route and applicable document conditions.
  • This does not imply that a CFS, legalization or new QMS certificate is required for every administrative change.

Applies to the stated national Russian dossier-change rule. The cited clause does not establish the EAEU procedure, a universal combined filing or an empirical turnaround forecast.

Conditions for this question

  • This evidence covers only the stated national dossier-change case. It does not establish transfer of a registration to an unrelated manufacturer/holder, recovery from a partner, or permission to combine every requested change in one filing.
Change control →Official forms & portals →Dossier requirements →
Regulation codes

What these codes are

Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.

Use this market context

Continue from regulations into practical research

Keep Russia as the target market while you move into registration records, classification, cross-country product research, or pathway planning.

Classify a device for Russia

Check a preliminary Roszdravnadzor risk class.

Search registered products

Inspect public Roszdravnadzor records.

Compare products across markets

Search the same product in multiple country registries.

Build a registration plan

Estimate pathway, government fees, preparation, and review time.

Build a reusable product master

Structure company, product, model, approval, and evidence facts once.

Map dossier reuse and deltas

Compare existing evidence against Russia needs.

Build a market-launch workpaper

Connect route, evidence, labels, representatives, and launch dependencies.

Assess a regulatory change

Test a current Roszdravnadzor update against one product and its evidence.

Keep researching this market

More Russia medical device resources

View the Russia resource hub →
Compare regulations across all countries →
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Tracked from official Roszdravnadzor publications · row IDs are stable — cite as regulations:russia:eaeu-device-registration-decision-46-original-2016