Successfully navigating a Quality Management System (QMS) production inspection is a critical milestone for medical device registration in Russia and the EAEU. This mandatory audit verifies that your manufacturing processes and quality systems meet regulatory requirements. Our QMS inspection support service ensures you are fully prepared, minimizing risks and streamlining the path to a positive inspection report.
Who Conducts QMS Inspections?
In Russia, only organizations subordinate to Roszdravnadzor are authorized to perform these inspections. The two designated expert bodies are:
- All-Russian Research and Testing Institute for Medical Equipment (VNIIIMT);
- National Institute of Quality (NIK).
The inspection covers all production sites declared by the manufacturer for the medical devices under review. If a single site produces devices from multiple groups or subgroups, the inspection may cover all relevant categories in one audit. The outcome is a formal inspection report.
For medical devices of potential risk classes 1 and 2a, the production inspection results apply to all medical device groups. For medical devices of potential risk classes 2b and 3, the production inspection results apply to all medical device subgroups.
Types of Inspections:
- Primary: Initial inspection required for registration;
- Scheduled (Periodic): Conducted every 5 years for Russian registration, and every 3 years for EAEU registration, from the date of the primary inspection report;
- Unscheduled: Triggered by specific events or regulatory concerns.
An inspection report issued during national Russian registration cannot be used for EAEU registration.
Our QMS inspection support services help manufacturers maximize the value of their existing quality certifications during the production inspection process.
If a medical device manufacturer has implemented a quality management system in accordance with the Interstate Standard GOST ISO 13485 or equivalent standards, documented evidence of system conformity serves to demonstrate compliance with regulatory requirements regarding QMS processes and procedures. Such evidence includes:
- A certificate of conformity issued by an accredited certification body;
- Quality system audit reports.
In this scenario, the production inspection is limited to verifying compliance with requirements related to:
- Design and development processes;
- Production processes and final product control;
- Customer-related processes (specifically regarding post-market surveillance).
Document management processes and corrective and preventive action (CAPA) processes are not subject to verification during the production inspection when valid certification evidence is provided.
- Document Collection & Analysis: Gathering and preliminary review of all documents required for the production inspection, including for all declared production sites and medical devices
- Inspection Organization: Selection of the inspection organization (VNIIIMT or NIK), preparation and submission of the application and documents for the inspection contract, and coordinate the engagement of certified technical translators if needed
- Contract & Scheduling: Conclusion of the inspection contract and negotiate inspection dates directly with the inspectors, payment of invoices by the Applicant
- On-Site Inspection Support: Our experts accompany you during the inspector’s visit to your production facilities, facilitating communication and clarifying queries
- Inspection Report: Preparing a report based on the inspection results. We analyze the draft inspection report and discuss findings with you
- Corrective Action Management: If non-conformities are identified, we help you develop and document effective corrective action plans
- Final Report Acquisition: We ensure the final positive inspection report is issued and delivered
QMS Inspection Support – Timelines for Medical Device Production Inspection Preparation & Execution:
Approximately 4 to 6 months
QMS Inspection Support – Standard Duration of Production Inspections by Employee Count:
The official cost of the inspection service itself is calculated according to Orders of the Ministry of Health of Russia No. 91n (February 18, 2022) and No. 726n (July 21, 2020).
Our Service Fees for QMS Inspection Support:
From $550
Facing a QMS production inspection? Let our experts guide you through every step. Request inspection support today.
