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Class I · IIa · IIb · III Overview

Class I — Low Risk​

Class I devices present the lowest risk to patients and users. They are typically non-invasive, do not contact the body, or only contact intact skin.

Typical Class I devices:

  • Bandages and wound dressings (non-sterile)
  • Hospital beds and furniture
  • Stethoscopes
  • Non-powered surgical instruments
  • Corrective eyeglass frames

Regulatory implications: Class I devices require a full registration dossier under the national or EAEU pathway. No QMS inspection is required. Where adequate clinical documentation exists, clinical testing in Russia may be waived. Timelines are generally shorter — fast-track registration (5 working days) may be available for certain Class I devices.

Class IIa — Low to Medium Risk​

Class IIa includes devices that are short-term invasive, active diagnostic devices, or devices that interact with body fluids.

Typical Class IIa devices:

  • Dental drills and filling materials
  • Hearing aids
  • Surgical sutures
  • Short-term intravascular catheters
  • Ultrasound imaging devices

Regulatory implications: Class IIa sterile devices require a mandatory QMS inspection before submission, in force since January 2024.

Class IIb — Medium to High Risk​

Class IIb devices present higher risk — they may be long-term implantable or support vital physiological functions.

Typical Class IIb devices:

  • Lung ventilators and anaesthesia machines
  • Orthopaedic implants (hip, knee)
  • Long-term intravascular catheters
  • Infusion pumps
  • Blood bags

Regulatory implications: Mandatory QMS inspection is required since January 2024. For IIb implantable devices registered after January 2021, an annual clinical post-market monitoring report must be submitted to Roszdravnadzor.

Class III — High Risk​

Class III includes active implantable devices and the highest-risk devices with direct contact with the central nervous system, heart, or central circulation.

Typical Class III devices:

  • Cardiac pacemakers
  • Implantable defibrillators
  • Coronary and vascular stents
  • Heart valves
  • Cochlear implants
  • Neural stimulators

Regulatory implications: Mandatory QMS inspection before registration submission. Clinical testing in Russia is almost always required. Annual clinical post-market monitoring reports must be submitted to Roszdravnadzor for devices registered after January 2021. Registration timelines can be up to 24 months.

Official sources
  • Classification: MOH Order No. 4n
  • QMS mandatory requirements: Government Decree No. 135 and No. 136
  • Annual PM monitoring: Regulation No. 1113