Effective January 1, 2024, a mandatory inspection procedure for the production of sterile medical devices classified as risk class 2a, as well as all medical devices in risk classes 2b and 3, is required. This involves assessing the manufacturing conditions and the quality management system of the medical device manufacturer to ensure compliance with established Requirements. Production inspection is a critical step in obtaining a registration certificate for a medical device.

Types of Production Inspections:

• Initial Inspection: Conducted as part of the registration process for medical devices.
• Periodic Inspection: Routine inspections are to be carried out every three years.
• Unscheduled Inspection: Carried out in response to adverse events posing a threat to patient health and safety.

Documentation and implementation of the quality management system must comply with ISO 13485: 2003/GOST ISO 13485-2011. This standard outlines comprehensive requirements, ranging from management processes to infrastructure, procurement control measures, and corrective actions.

Creating and integrating appropriate systems necessitates thorough internal analysis of all procedures, control measures, equipment, training, and accountability. It also requires the development of new, proven processes along with evidence of their effectiveness.

Production inspections are conducted by organizations subordinate to Roszdravnadzor.

The duration of the inspection depends on the type of inspection, the risk class of the medical device, the actual number of employees at the inspection site, the location of the production, the size of the production area, and is determined on a case-by-case basis.

Regulations stipulate that the duration of the inspection should not exceed 90 working days, and an additional 60 days are allowed for addressing any identified issues.

At NVR Consult Group, we offer comprehensive support to guide your company through the production inspection process.