Registration Change Procedures in Russia: Routes, Timelines and Fees

1. Key takeaways

Resolution No. 1684 establishes two procedures for changing the registration dossier. A change that does not require expert review (the cases listed in para. 111) can be completed in as little as 5 + 3 + 10 working days. A change that requires expert review takes 5 + 3 + 3 + 15 + 10 working days. The fees for the two routes differ by two orders of magnitude: from 2,500 rubles on the simple route versus from 32,000 rubles on the expert review route. Which category a change falls into is therefore the key decision point of any amendment project, and it should be made deliberately, with a documented classification argument, rather than by default.

Beyond the fee difference, the two routes carry different evidentiary burdens. The simple route presumes that the change does not touch the substance of the product, so the dossier update is largely administrative. The expert review route subjects the change to a fresh assessment, with the possibility of questions, deficiency notices and a materially longer calendar. Planning the amendment pipeline around the correct route assignment is one of the cheapest ways to control both the budget and the timeline of a device portfolio in Russia.

2. Legal basis

The two procedures, their deadlines and the exceptional cases in which a change triggers clinical requirements are defined in a small set of federal instruments. The table below lists each act with its reference number, date and the relevant provisions.

3. Expert insights

Insight one: classify changes by whether they touch the substance of the product. An address change caused by the renaming of a street or the rearrangement of building numbers falls squarely under para. 111. By contrast, design changes and expansions of indications can engage subparas. в and г of para. 31, which means a human clinical trial is required. At that point the amendment is a project of a different magnitude altogether, with its own study planning, costs and ethics considerations. The classification argument should be prepared in writing before any submission, because the route chosen determines both the fee and the evidence package.

Insight two: a QMS evaluation can buy access to the simple route. For class 1 devices and non-sterile class 2а devices that have passed a QMS evaluation covering the design and development process, certain changes can be exempted from expert review under subpara. б of para. 111, provided the inspection report is still valid. This is a rare case of a management-system investment converting directly into procedural simplification. Manufacturers whose certification scope already covers design controls should make sure the certificate and report are maintained in force, because the exemption is only available within the validity of the report.

Insight three: the time spent answering questions is not counted in the procedure. Curing defects can take up to 30 working days, and answering expert queries up to 50 working days, without either period counting toward the statutory duration. The real calendar time of an amendment is therefore often decided by these two windows rather than by the formal stage deadlines. Preparing a complete, internally reviewed submission package is the most reliable way to keep the deficiency window empty or short.

Insight four: the 90-working-day ceiling disciplines the whole plan. The provisions give the authority a maximum of 90 working days for the procedures, but they do not suspend that ceiling for an applicant’s own delays. A change dossier that sits idle while the manufacturer gathers documents consumes the same regulatory calendar as everyone else’s, so sequencing internal evidence collection ahead of filing matters more than the formal submission date.

4. Practical recommendations

The steps below turn the two-route structure into a manageable amendment process. They are aimed at regulatory teams that handle multiple changes per year across one or several certificates.

1. After a change occurs, prepare the classification argument first and document it in writing before deciding whether to file.
2. Avoid scattering submissions: batch non-urgent changes quarterly, since each scattered filing consumes a separate correction cycle.
3. For changes involving design or intended use, evaluate the clinical trial requirement early, so the project does not change route midway.
4. Track the validity of QMS inspection reports for class 1 and non-sterile 2а devices, and renew them in time to preserve the para. 111 exemption.
5. Keep a running log of the working days consumed at each stage of every amendment, so that internal planning assumptions converge on the real durations observed with the authority.

5. Verification checklist

Confirm each item below before filing an amendment. The checklist follows the decision sequence: route, timeline, fees and evidence.

• □ The classification argument for the change has been completed (para. 111 or para. 119)
• □ The timeline and fee have been estimated under the corresponding procedure
• □ If a valid QMS evaluation exists, the applicability of subpara. б of para. 111 has been assessed
• □ For changes touching design or intended use, the human clinical trial requirement has been evaluated
• □ The filing falls within the 90 working days time limit

Regulatory information verified as of 29 October 2026.

GRZAN manages registration changes in Russia end to end: classification arguments for each amendment, preparation and filing of dossiers under either procedure, coordination of QMS documentation and consolidated scheduling of change batches to control fees and timelines. For change-management support, contact GRZAN at info@grzanglobal.com.