Three National Registration Tracks Under Clauses 63, 87 and 101

1. Key takeaways

Resolution No. 1684 divides national registration into three tracks according to whether human clinical trials are required and whether the device is Russian-made: п. 63 (requiring human clinical trials with authorization from the competent authority, пп. 63–86), п. 87 (requiring no such trials, including devices incorporating artificial intelligence technology, пп. 87–100), and п. 101 (special registration provisions for domestic Russian devices, пп. 101–109). The three clauses have been confirmed by Resolution No. 2214 to apply until December 31, 2027.

Track selection is therefore the first regulatory decision of any national-pathway project, because it fixes the procedural sequence, the statutory durations, the state fee category under the Tax Code and the depth of clinical evidence required. Determining the track before dossier drafting prevents rework and keeps the project plan aligned with the applicable procedural clock.

The track distinction also carries financial consequences through the state fee provisions of Article 333.32.2 of the Tax Code, which assign different fee amounts to the three cases. Because fees are fixed per case and are part of the submission package, an incorrect track determination surfaces early — at fee payment and acceptance of the application — while a correct determination made late still forces a redo of the trial-related planning. Fee differences are rarely the deciding factor in track selection, but they belong in the project budget, together with the cost of the clinical trial itself where the п. 63 track applies. A budget that models only administrative fees for a trial-bearing project understates the real cost by an order of magnitude.

2. Legal basis

The three tracks are defined within Resolution No. 1684, prolonged by Resolution No. 2214, and supported by the new conformity assessment procedure of Order No. 421н and the fee provisions of the Tax Code. The table below lists the relevant instruments.

3. Expert insights

Insight one: the track is determined by clinical need, not by manufacturer preference. When any of the six categories of grounds for human clinical trials listed in п. 31 applies, the п. 63 track is mandatory: the draft clinical trial plan must be submitted together with the application, the registration procedure is suspended during the trial, and the second-stage expert review resumes after the trial is completed. Attempting to characterize a device as exempt from trials when a п. 31 ground applies is not a strategy but a defect, and it will surface during expert review.

Insight two: the two-stage review time can be quantified. Under the п. 63 track, the first-stage review can take up to 17 working days, the second stage after trial completion up to 8 working days, with additional milestones of 5 working days for the authorization decision and 10 working days for responses to interested persons. These segments together form the minimum timeline for such a project. The trial itself, ethics review and recruitment sit on top of these durations, so the total calendar time is dominated by clinical execution rather than administrative processing.

Insight three: AI-containing devices have dedicated provisions under the п. 87 track. In addition, the penalty clause of Resolution No. 1684 (subitem з of п. 137) imposes separate constraints on the change procedure for AI software: making changes on grounds other than those provided by п. 135 constitutes grounds for revocation. This means that iteration of AI software cannot be treated as an ordinary software change; version planning must map each intended change to an allowed category under п. 135 before release, or the certificate itself is placed at risk.

For AI-containing devices, the governance implications extend beyond the registration procedure itself into product engineering. Because subitem з of п. 137 makes changes outside the grounds of п. 135 a revocation risk, the software release process becomes a compliance-controlled activity: each version must be evaluated against the authorized change categories before deployment, and the evaluation record should be kept alongside the release notes. Engineering teams accustomed to continuous deployment may find this discipline restrictive, but it is the price of holding a certificate for a learning-capable device under the current rules. Establishing a joint regulatory-engineering review board for AI releases, with a documented decision trail per version, is the practical way to keep both innovation velocity and certificate security.

4. Practical recommendations

1. At project initiation, perform a formal determination of whether human clinical trials are required, select the track accordingly, and set the timeline from that determination. Record the reasoning against the six grounds of п. 31 so that the track choice is defensible in later audit or expert review.
2. Design the version iteration plan for AI software products before registration, and check against п. 135 which changes are permitted through the change procedure. Build the release-management workflow around the allowed categories so that engineering teams do not ship updates that fall outside the authorized scope.
3. For п. 63 track projects, write the suspension and restart administrative milestones into the project plan, and do not misjudge the process as one continuous flow. Stakeholders should expect an administrative pause while the trial runs, and resources for trial monitoring and post-trial submission should be budgeted from the start.

5. Verification checklist

• □ The clinical need determination has been completed against the six grounds of п. 31 of Order No. 421н
• □ The corresponding track (п. 63 / п. 87 / п. 101) has been selected and entered in the project plan
• □ The applicable expert review stages and durations (17/8 working days and related nodes) have been entered in the Gantt chart
• □ The change category for AI products has been verified against п. 135 and subitem з of п. 137
• □ The submission date falls before December 31, 2027

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Russian market with end-to-end regulatory services covering both registration pathways: national registration under ПП РФ No. 1684, including route selection among clauses 63, 87 and 101, and EAEU registration under ЕЭК Decision No. 46, together with classification strategy support under Decision No. 173 as amended. Our team helps define the optimal route for each registration unit, prepare dossiers and testing plans, coordinate with RZN and expert institutions, and track transition deadlines through December 31, 2027. For tailored support on Russia market entry, pathway selection and dossier preparation, contact GRZAN at info@grzanglobal.com.