How Classification Works
Risk-based classification
Russia uses a risk-based four-class system aligned with the European model. Medical devices are assigned to one of four classes based on the degree of potential risk to patients and users:
| Class | Risk level | Examples |
|---|---|---|
| Class I | Low risk | Bandages, hospital beds, non-sterile surgical instruments, stethoscopes |
| Class IIa | Low-to-medium risk | Dental fillings, hearing aids, sutures, short-term implantable devices |
| Class IIb | Medium-to-high risk | Lung ventilators, bone fixation plates, long-term implantable devices |
| Class III | High risk | Active implantable devices, coronary stents, heart valves |
OKPD-2 classification codes
Russia's classification system uses OKPD-2 codes (All-Russian Classifier of Products by Economic Activity). Each registered device must have an assigned OKPD-2 code, which also determines its class. Roszdravnadzor maintains an official list of medical devices with corresponding OKPD-2 codes and risk classes.
Selecting the correct classification code is critical — it determines which registration pathway applies, whether a QMS inspection is required, and what clinical evidence must be provided.
Who determines classification
The applicant selects the classification code from the official OKPD-2 list when preparing the registration dossier. Roszdravnadzor and the FGBU expert institutions review this as part of Phase 1 of the registration process. If the code is disputed or uncertain, you can seek a formal opinion from Roszdravnadzor.
IVD classification
IVD devices follow the same four-class framework. Class is determined by the intended use and the risk to the patient if a false result is obtained. High-risk IVDs (for example, HIV tests, blood typing reagents) fall into higher classes.
Practical implications of class
| Class I | Class IIa | Class IIb | Class III | |
|---|---|---|---|---|
| QMS inspection | Not required | Required if sterile (from Jan 2024) | Required (from Jan 2024) | Required (from Jan 2024) |
| Clinical testing in Russia | May be waived | May be waived if data available | Generally required | Required |
| Registration timeline | 5 working days (fast-track possible) | 6–12 months | 12–18 months | Up to 24 months |
Classification rules: MOH Order No. 4n — minzdrav.gov.ru