IVD Registration in Russia: One Track, Two Testing Paths

1. Key takeaways

In vitro diagnostic devices (IVD) in Russia do not follow a separate licensing track. They fall under the same registration system as other medical devices and likewise receive a national registration certificate. The difference lies in the form of conformity assessment: the technical content and performance of an IVD are examined through clinical laboratory testing, and the structure of the supporting studies differs accordingly from the testing programs used for instruments and physical devices.

A significant change took effect on September 1, 2026: certain IVD reagents, calibrators, quality control materials, wash solutions, diluents, and culture media no longer require the technical testing stage under adjustments introduced by Order No. 421n. For manufacturers of reagent-based products, this shortens the assessment path considerably, while instruments and complete systems continue to bear the fuller burden. The practical task for every IVD project is therefore to determine, at the outset, which side of the exemption line the product falls on, and to schedule the remaining evidence work accordingly.

The classification work also matters as much as the testing work. IVD products receive their type codes from the same nomenclature catalogue as other devices, and the code determines the recommended risk class, which in turn shapes the expert review fee and the depth of the dossier. Because the 2025 amendment to the union classification rules changed the treatment of in vitro diagnostic devices, IVD conclusions reached under the earlier approach should be re-verified rather than reused. A project that combines a current classification basis with a correct reading of the exemption list starts with an accurate budget, and an accurate budget is what keeps an IVD program funded through expert review without renegotiation.

2. Legal basis

3. Expert insights

Insight 1: Exemption from technical testing does not mean less evidence. The exemption applies to specific IVD formats: reagents, reagent kits, calibrators, quality control materials, wash solutions, diluents, certain plastic consumables, and culture media. For these, performance evidence shifts to clinical laboratory testing, while instrument-type IVD products generally still require technical testing. When scheduling a project, first confirm whether the product falls within the exemption list or needs testing on both sides, because the sequencing, the laboratories involved, and the timeline differ substantially between the two situations.

Insight 2: Biological material must come from a local Russian reference population. Order No. 421n requires that the patient biological material used in IVD clinical laboratory testing be obtained from the relevant reference population within Russia, and it permits the use of residual, archived, or specially collected samples. This means that overseas clinical data cannot fully substitute the local verification stage. Planning for sample access, ethics arrangements, and laboratory agreements should therefore start early, since sourcing is the element least controllable from abroad and most likely to consume calendar time.

Insight 3: The transition node is divided by the date of application submission. Conformity assessment for which the application was submitted to a testing laboratory or medical institution before September 1, 2026 continues to be governed by Order No. 885n. For IVD projects currently in execution, documents evidencing the application date should be preserved as the basis for applying the earlier procedure. A dated submission receipt, an email confirmation from the laboratory, or a formal acceptance record all serve this purpose if kept alongside the project file.

4. Practical recommendations

1. Place local biological material acquisition on the critical path of the project schedule. Among all IVD project elements, this is one of the most frequently underestimated in terms of time, and delays here block clinical laboratory testing entirely.
2. For IVD products related to emerging and re-emerging infections, take note that Order No. 421n allows genetic engineering samples to be used as reference materials in addition to engineered strains, which can ease sourcing for difficult pathogens.
3. For projects in progress around September 1, 2026, retain evidence of the application date and re-assess the testing scope against the exemption list; this may reduce testing expenditure for reagent-format products.
4. Agree the form and language of test result documents with the laboratories in advance so that the reporting format matches what the registration dossier requires.

5. Verification checklist

• □ It has been confirmed whether the product is an exempt-format IVD without technical testing, or requires the full two-sided testing
• □ The source of biological material from the Russian local reference population has been secured with a written agreement
• □ Transition-period projects have retained proof of the application submission date to the testing institution
• □ The form of results and documents complies with the appendices of Order No. 421n (electronic form permitted)
• □ Results and data have been incorporated into the reporting arrangements of the RZN automated information system

GRZAN manages IVD registration projects in Russia end to end, from exemption analysis under Order No. 421n and selection of local laboratories to coordination of clinical laboratory testing with Russian reference populations. Our team tracks the transition between Order No. 885n and Order No. 421n for in-flight projects, preserves the evidence of application dates, and structures IVD dossiers for smooth expert review. For IVD registration and RZN compliance support, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.