Quality and Safety Control of Medical Care

The Russian medical device market has been demonstrating sustained growth, while the country’s goal of technological sovereignty is fuelling the trend of import substitution. A top priority is to establish a domestic production base for raw materials and components that are essential to manufacturing finished products. The raw material and component production stage is where the fundamental quality and safety parameters of the final products are established. Whether or not these parameters are effectively controlled depends on the interaction between internal quality management systems and external oversight. Independent testing and certification of raw material manufacturers verify product safety, complementing these systems and laying the groundwork for the entire subsequent control chain. Mandatory labelling and a unified identification information system ensure quality traceability throughout the product lifecycle. Such infrastructure dictates the effectiveness of the risk-based approach, which helps conserve public resources and shifts the focus of inspections toward prevention, thereby fostering a safe business environment and creating long-term market development prospects. How can we evaluate the effectiveness of the risk-based approach in terms of the quality and safety of medical devices? What preventive tools are most useful for all links in the supply chain – from raw material suppliers to the final stage of distribution? How can we align external oversight with internal quality management systems during the production of raw materials and finished goods? How can manufacturers and regulators collaborate to set import substitution goals? What barriers are hindering the shift toward local suppliers, and what state support measures are needed? How do labelling and traceability protect the market against counterfeit products and guarantee the safety and quality of medical devices? What trends will shape the future of the Russian medical device market and the business strategies of its players?