Suspension and Cancellation Grounds under Decision No. 1684

1. Key takeaways

Paragraph 137 of Decision No. 1684 is the consolidated provision for the suspension and cancellation of a state registration, and it follows a two-stage structure: suspension first, cancellation afterwards. The four trigger conditions most relevant in practice, and the suspension periods attached to them, are: authorised representative information not updated — 90 working days (applicable from 1 September 2027); production inspection information missing — 180 working days; ПКМ report not submitted on time — 30 working days; and changes made to AI software for reasons outside the permitted list, which constitutes a ground for cancellation outright.

The structure matters as much as the numbers. Suspension is a remediation window with a defined length; cancellation is the standard consequence if the violation is not eliminated within it. Because most triggers concern information duties rather than technical defects, the practical defence is administrative: registers that track update deadlines, submission deadlines and change justifications, and a rehearsed process for filing corrective materials the moment a suspension notice arrives. Companies that manage paragraph 137 items in a spreadsheet with named owners rarely reach the cancellation stage at all.

It also pays to read the grounds together rather than one at a time. The 90 working day period attached to representative information only applies from 1 September 2027, so the update duty must be completed long before the consequence attaches. The 180 working day period attached to production inspection information is the longest window, but it runs on information that arrives from outside the company, which makes external follow-up, not internal drafting, the critical path. The 30 working day period attached to the ПКМ report is the shortest, and it is examined in detail in the dedicated article on post-market clinical monitoring.

2. Legal basis

The suspension and cancellation grounds are concentrated in the registration rules, amended in 2025, with the validity of the rules itself extended to the end of 2028. The safety monitoring order connects the handling chain to event-driven measures. The instruments are summarised below.

3. Expert insights

Insight 1: for nearly all grounds, the remediation window is the suspension period. The drafting of the provision gives a chance to cure: if the violation is eliminated within the suspension period, the registration is restored; once the period expires without elimination, cancellation is the standard consequence. The first task after receiving a suspension notice is therefore to calculate the remaining working days, not to discuss internal responsibility. Every day spent on attribution rather than on the corrective submission is a day subtracted from the cure window.

Insight 2: most triggers are failures of omission. Information not updated, reports not submitted, inspection information not followed up in time — these arise from missing registers rather than technical defects, which means the return on managerial investment is very high. A paragraph 137 register that lists every ground, the corresponding data field, the owner and the review frequency converts an open-ended legal exposure into a checklist that can be closed monthly.

Insight 3: the rules for AI software are the strictest. Changes made on grounds other than those listed in p. 135 constitute a ground for cancellation directly (subparagraph “z” of p. 137), with no intermediate suspension buffer. This collides frontally with the rapid iteration rhythm typical of AI products, and it must be contained at the level of the version strategy: release planning, change classification and registration impact assessment have to precede development, because after a non-permitted change has shipped, there is no cure window to fall back on.

4. Practical recommendations

The recommendations below aim at preventing suspension in the first place, and at shortening the cure path when suspension nevertheless arrives.

1. Maintain a paragraph 137 register: list every ground, the corresponding field, the responsible person and the review frequency, and review it monthly with the same discipline as a quality metric.
2. Start the corrective submission immediately when a suspension notice arrives, and schedule the work in working days, using a template prepared in advance rather than drafted during the window.
3. Bind the version release process of AI software to a list of permitted change grounds checked against p. 135, and require a documented assessment before any release that touches the registered configuration.
4. Track the 1 September 2027 start of the authorised representative information consequence in the register now, and complete the update well before penalties begin to run.

5. Verification checklist

Use the checklist to confirm that each high-risk ground is actively managed rather than merely known.

• □ The paragraph 137 register has been compiled and a responsible person designated
• □ The three high-risk items — representative information, inspection information and ПКМ reports — are all in the register
• □ The change grounds of each AI software product are confirmed item by item against p. 135
• □ A working day schedule template for corrective submissions is prepared
• □ The external communication position on suspension / cancellation events is defined
• □ The register is reviewed at a fixed monthly frequency with recorded outcomes

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers in Russia with suspension and cancellation risk management under p. 137 of Decision No. 1684, including compliance registers, corrective submissions inside suspension windows and AI software change governance, together with vigilance, recall and inspection readiness services. For support, contact us at info@grzanglobal.com.