Enforcement & Compliance
Roszdravnadzor · Federal Law No. 323-FZ · Government Decree No. 1684 (March 2025)
Overview
Roszdravnadzor (RZN) — the Federal Service for Surveillance in Healthcare — has broad enforcement powers over medical devices on the Russian market. Enforcement applies to both the Russian Authorized Representative (RUS REP) and, where accessible, to overseas manufacturers. Healthcare facilities, distributors, and importers are also subject to RZN oversight.
Types of Inspections
| Inspection Type | Trigger / Frequency |
|---|---|
| Manufacturing site inspection | Mandatory for Class IIa (sterile), IIb, and III from January 2024 — at registration and periodically |
| Market surveillance | Routine sampling and testing of devices on the market |
| Complaint-triggered inspection | Following adverse event reports or healthcare facility complaints |
| Post-registration audit | To verify continued compliance after registration certificate issuance |
| Border / Customs inspection | Coordination with Federal Customs Service to check import shipments |
| Healthcare facility inspection | Verification that healthcare facilities use only registered devices |
Manufacturing Site Inspections (Class IIa sterile, IIb, III)
From 1 January 2024, manufacturing site inspection by Roszdravnadzor (or an accredited inspection body) is mandatory for Class IIa (sterile), IIb, and Class III devices as part of the registration process. This applies to both new registrations and renewals for these classes.
Inspectors assess:
- ISO 13485 QMS implementation and scope
- GMP compliance at the manufacturing facility
- Technical documentation accuracy
- Sterilisation processes (for sterile devices)
- Record-keeping systems
See Manufacturing Site Inspections for inspection preparation guidance.
Enforcement Actions Available to Roszdravnadzor
| Action | Description |
|---|---|
| Warning letter (предписание) | Formal notice requiring corrective action within a specified period |
| Suspension of registration | Temporary suspension of the State Registration Certificate pending investigation |
| Cancellation of registration | Permanent cancellation of the Registration Certificate for serious violations |
| Market withdrawal order | Direction to withdraw a device from circulation |
| Product seizure | Physical seizure of non-compliant, unregistered, or unsafe devices |
| Import suspension | Prohibition on further importation of a device |
| Administrative fine | Financial penalties imposed under the Code of Administrative Offences |
| Criminal prosecution | For serious violations causing harm to patients |
Administrative Penalties
Under the Code of Administrative Offences of the Russian Federation (KoAP RF):
| Offence | Penalty Range |
|---|---|
| Supply of unregistered medical device | Fine on the organization; possible product seizure |
| Violation of labelling requirements | Fine; may include product withdrawal |
| Falsification of registration documents | Higher fines; potential criminal liability |
| Failure to report adverse events | Administrative fine |
| Non-compliance with Chestny ZNAK marking | Fine; sales blockage |
Exact fine amounts are set in the KoAP and are subject to change. For current penalty ranges, consult a Russian legal advisor.
Criminal Liability
Serious violations — particularly those that cause patient harm or involve deliberate falsification of documents — can result in criminal prosecution of responsible individuals under the Criminal Code of the Russian Federation. Directors and QA officers of the RUS REP can be personally liable.
Unregistered Devices
Supplying a medical device that is not registered in the GRLS state register (or that has an expired or suspended registration) is one of the most serious violations. Roszdravnadzor actively monitors the market for unregistered devices and coordinates with customs to intercept unregistered imports.
Operating on an expired registration is treated as supply of an unregistered device. Monitor registration expiry dates carefully and initiate renewal well in advance.
Responding to Enforcement Actions
If Roszdravnadzor issues a notice or enforcement action:
- Acknowledge the notice in writing within the specified timeframe — non-response may escalate the action
- Engage a Russian regulatory advisor or legal counsel experienced in Roszdravnadzor matters
- Prepare a corrective action response (CAPA) addressing all cited deficiencies with evidence of implementation
- Cease supply of any affected products while the matter is under investigation (unless instructed otherwise by RZN)
- Do not resume supply without written Roszdravnadzor clearance
RUS REP Liability
The Russian Authorized Representative is the primary enforcement target for foreign manufacturers. The RUS REP holds the Registration Certificate and is the entity Roszdravnadzor contacts. Foreign manufacturers without a RUS REP cannot be registered or directly regulated. Ensure your RUS REP has clear contractual obligations to notify you promptly of any enforcement actions.
See Authorized Representative for RUS REP obligations.
Post-Market Signal Response
Roszdravnadzor monitors international safety databases and may issue formal requests for information following safety signals in other markets (FDA, EMA, TGA). The RUS REP must respond to these requests promptly. International FSCAs may trigger mandatory withdrawal action in Russia.
See FSCA and Recalls for the full FSCA notification framework.
Cooperation With Inspectors
During any Roszdravnadzor inspection:
- Designate a competent Russian-speaking point of contact
- Provide requested documentation promptly (all documentation must be available in Russian)
- Do not obstruct or delay the inspection — this is a separate offence
- Request and retain a copy of any inspection report and samples taken