Conformity Assessment Under Order No. 421n and Mandatory Clinical Trial Grounds

1. Key takeaways

Order No. 421n of the Ministry of Health of Russia, dated May 13, 2026 (registered with the Ministry of Justice on June 1, 2026 under registration number 86767), replaces Order No. 885n from September 1, 2026 and remains in force until September 1, 2032. Its p. 31 expands the situations in which clinical trials with human participation are mandatory from four categories under the previous rule to six. In all other situations, clinical evaluation can be completed through the analysis and evaluation of existing clinical data, which keeps most devices on the documentary path and reserves human trials for genuinely new or materially changed products.

For manufacturers this redrawing of the boundary has a direct planning consequence: the six grounds of p. 31 must be assessed for every new application and, importantly, for change projects as well, because design changes affecting intended use or the principle of action now sit squarely inside the mandatory-trial zone. Companies that institutionalise this assessment as a standard gate in their change-control process avoid late discoveries and can sequence ethics review and trial preparation before the change application is filed.

The documentary path still demands substance. Where the sponsor relies on the analysis and evaluation of existing clinical data, that analysis must be genuine: a structured review of the data, an assessment of its applicability to the Russian intended use and a documented conclusion on effectiveness and safety. A thin literature compilation does not satisfy the requirement, and expert reviewers are experienced in distinguishing reasoned evaluation from decoration. The same rigour applies to the choice of comparators and endpoints when the documentary path is combined with change projects.

2. Legal basis

The instruments defining when human clinical trials are mandatory are summarised below.

3. Expert insights

Insight 1: all six grounds have precise boundaries. They include: novel products for which the nomenclature classification contains no analogous device (item “a”); fundamentally new and complex, unique or special methods and technologies for prevention, diagnosis and treatment (item “b”); design changes affecting the intended use or the principle of action (item “v”); expansion of the list of indications or a change of intended use (item “g”); situations where the analysis and evaluation of existing clinical data cannot confirm effectiveness and safety (item “d”); and materials whose biological effects have not been studied, or known materials used for new organ or tissue types or longer contact durations (item “e”). Each ground should be checked against the concrete product description, not against a general impression, because the wording is technical and the burden of proof lies with the applicant.

Insight 2: the two new grounds affect change projects directly. Under the new rules, a sponsor who wishes to expand indications or alter the principle of action after registration must run a human clinical trial. At the same time, in change scenarios an RZN permit for the clinical trial is not required (the ethics committee conclusion is still needed). This shortens the administrative chain and shifts all the preparatory work onto the clinical protocol itself: sites, endpoints, population and statistics must be right at the first submission to the ethics committee, because the permit stage no longer provides a second filtering gate.

Insight 3: September 1, 2026 is a clearly defined dividing line. The scope of p. 31 covers applications submitted after that date for the system in question, and the decisive criterion is the date of the application to the laboratory or medical organisation, not the date of completion of the trial. Sponsors with projects straddling the boundary should archive the application date evidence and state in the dossier which procedure version applies and why, so that reviewers do not need to reconstruct the chronology themselves.

4. Practical recommendations

1. For products with planned indication expansions, perform an assessment of whether the change falls under items “v” or “g” of p. 31 before filing the change application.
2. Include the ethics committee review time, which can reach 30 working days, in the critical path of the project plan.
3. For transition-period projects, keep dated proof of the application, and state in the dossier the basis on which the previous procedure applies.
4. Prepare the clinical protocol to the level of ethics-committee readiness from the outset, since in change scenarios there is no permit stage to absorb preparatory iterations.
5. Document the analysis of existing clinical data where the documentary path is used, so that the choice not to conduct a trial is traceable to a reasoned evaluation.

5. Verification checklist

• □ The product situation has been assessed against each of the six grounds of p. 31
• □ Projects involving indication expansion or design changes have been confirmed as requiring, or not requiring, human clinical trials
• □ The ethics committee conclusion has been scheduled (including the 30 working day review window)
• □ It has been confirmed whether the situation falls under the permit exemptions of p. 32
• □ Dated proof of the application has been archived to demonstrate the applicable procedure version

Regulatory information verified as of October 29, 2026.

GRZAN advises manufacturers on clinical evaluation strategy under the Russian conformity assessment procedures, including the assessment of the six mandatory-trial grounds of p. 31, the preparation of clinical data analyses and evaluation reports, and the coordination of ethics committee submissions. Our team helps you determine early whether your product or change project needs a human clinical trial. For support with Russian clinical evidence and registration documentation, contact us at info@grzanglobal.com.