Technical Testing Requirements for Medical Device Registration in Russia

1. Key takeaways

Technical testing must be carried out by a laboratory or testing centre that holds accreditation with the relevant scope within the Russian national accreditation system, and the results are presented as a technical test report in the format recommended by the annexes of Order No. 421n. From September 1, 2026, certain in vitro diagnostic reagents and accessories are exempt from technical testing, while instruments and ordinary devices continue to undergo it in full. The exemption does not shorten the overall registration path by itself: it simply moves the evidentiary weight towards clinical laboratory testing for the affected IVD categories, and sponsors should plan the evidence package accordingly.

Because the choice of the testing organisation lies with the applicant, the accreditation scope check is a project-critical step. A centre whose accreditation does not cover the product type, or whose report does not follow the recommended format, produces results that may be challenged during expert review. Verifying scope, experience with similar products and format compliance before signing a contract costs little; discovering a defect in the report after submission costs a full supplementation cycle inside the review timeline.

The scope exemption of 2026 also changes how budgets should be read: a sponsor of an exempted reagent does not pay for bench testing of that reagent, but the clinical laboratory programme that replaces it has its own costs in protocol design, specimen acquisition and laboratory fees. Conversely, instruments and general devices see no relief at all, and their testing plans should be made under the assumption that the full technical testing cycle applies. Reading the exemption list category by category, rather than assuming that IVD means exemption, is the first task of the evidence plan.

2. Legal basis

The instruments governing technical testing under the new procedures are summarised below.

3. Expert insights

Insight 1: the choice belongs to the applicant, and so does the responsibility. The manufacturer or its authorised representative may independently determine the testing organisation, provided that the accreditation scope covers the product and the relevant requirements of Resolution No. 1684 are met. If the wrong centre is selected or the accreditation scope proves insufficient, the consequences are borne by the applicant, and they typically surface only at the expert review stage, when the calendar cost of correcting the file is highest. A documented scope verification at the contracting stage is therefore not bureaucracy but risk control.

Insight 2: the results are tied to the national standardisation system. The technical test report must be prepared in accordance with the current documents of the Russian national standardisation system, namely the GOST series. This differs from the CE framework, where the manufacturer often validates internal methods: the Russian approach emphasises methodological alignment with national standards rather than purely in-house verification. Teams arriving from an EU-focused process should plan for method translation and, where needed, additional testing to satisfy GOST-based expectations, and should discuss this openly with the testing centre before the test programme is fixed.

Insight 3: the transition node is anchored to the date of the application to the laboratory. Conformity assessment for which an application was submitted to a testing laboratory, testing centre or medical organisation before September 1, 2026 continues under the previous procedures. Keeping dated proof of the application therefore has direct financial and scheduling value: it preserves the old scope of testing where that is favourable and avoids partial rework. The evidence should be archived together with the correspondence that shows the product and scope stated in the application, so that the applicable procedure version can be demonstrated without ambiguity.

Format compliance deserves its own line in the project plan. A report that contains the right results but omits elements recommended by Annex 1 of Order No. 421n can be challenged on formal grounds alone, and re-issuing the report may take weeks depending on the laboratory’s internal procedures. Before accepting delivery of a report, compare it against the recommended format clause by clause, including the IVD-adapted version where applicable, and agree any corrections with the laboratory while the testing file is still open.

4. Practical recommendations

1. Confirm three things with the testing organisation before contracting: whether the accreditation scope covers the product, whether the centre has experience with similar devices, and whether it can issue a report in the format recommended by the annexes of Order No. 421n.
2. Import the test samples under a single-use import permit following Order No. 661n, and complete the permitting before the testing schedule is fixed, because samples without a permit cannot legally enter testing.
3. Discuss possible extensions with the laboratory in advance: the new procedures allow an extension where methods or methodological requirements are extended, commonly in the order of 20 working days, with the laboratory’s own procedures governing the specifics.
4. Align the sample version identifiers in the test report with all other dossier documents, so that the version chain remains unbroken from testing through to labelling.
5. Archive the dated application to the laboratory as the anchor for determining the applicable procedure version for transition-period projects.

5. Verification checklist

• □ The accreditation scope of the testing organisation covers this product
• □ The test report format complies with Annex 1 of Order No. 421n (including the IVD-adapted version)
• □ The sample import permit has been obtained (Order No. 661n)
• □ Transition-period projects hold dated proof of the application to the laboratory
• □ The sample version numbers in the test report match the other dossier documents

Regulatory information verified as of October 29, 2026.

GRZAN assists manufacturers with technical testing strategy for the Russian market, from selecting accredited testing organisations and verifying their accreditation scope to preparing sample import permits and aligning test reports with the formats required by the current conformity assessment procedures. Our consultants coordinate with laboratories so that the evidence package is right the first time. For support with Russian testing and registration documentation, contact us at info@grzanglobal.com.