Inspection of medical equipment manufacturers

Inspection of medical devices is a form of state control that is applied at the stages of production, handling and operation of medical devices. It applies to both manufacturers and importers, distributors and medical organizations. It is worth noting that the main purpose of the inspection is to verify the manufacturer's ability to consistently produce medical products that meet the requirements of the registration dossier and regulatory documentation.
During the inspection, the following are evaluated:
1. compliance with the requirements of the quality management system;
2. compliance of production processes with established standards;
3. Production, storage and product control conditions;
4. Staff qualifications;
5. the correctness of the documentation.
At the same time, special attention is paid to changes in the design, materials or software of the product during the inspection. If such changes were made without the approval of the regulator, this will be considered a violation.
The inspection procedure itself is based on the requirements for the implementation and maintenance of a quality management system, usually in accordance with the principles of the ISO 13485 standard, as well as national regulations. The inspection can be carried out as planned or unscheduled. Complaints, reports of undesirable events, identified risks to patients, or inconsistencies found during monitoring of medical device circulation are most often the basis for an unscheduled inspection. Based on the results of the inspection, Roszdravnadzor has the right to issue an order to eliminate violations, suspend the circulation of the product or prohibit its use altogether. In more serious cases, the materials may be transferred for administrative prosecution.