Mongolian Medical Equipment Regulations: Challenges in Clinical Engineering Development

To effectively deliver healthcare services, it is essential to strengthen and expand the education system for qualified clinical engineers and technicians. This should be combined with measures such as providing modern equipment to health facilities and making spare parts available. Internationally, one clinical engineer is typically responsible for approximately 100 pieces of equipment, while each large piece of equipment, such as magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET scan), and angiography machines, is assigned to a dedicated engineer. However, in our country, no standard exists linking the number of engineers to the quantity of medical equipment. The Law on Drugs and Medical Devices, adopted in 2024, stipulates that general hospitals, specialized centers, and specialized hospitals must have a dedicated unit responsible for the use and safety of medical equipment, while other healthcare institutions must employ a full-time or subcontracted engineer. However, biomedical engineers and technicians are not classified as “medical specialists” under the Law on Health. Although four universities nationwide train biomedical engineers and technicians, the number of graduates still does not meet the growing market demand. There is also a need to diversify and develop biomedical engineers in line with international standards, including certification. These findings underscore the need for structural reforms in clinical engineering training, legal recognition, and workforce planning in Mongolia.Objective: To assess the human resource needs and legal framework for medical equipment specialists and compare them with the WHO and regional country regulations.Methods: We used analytical, cross-sectional, and descriptive study designs. A total of 272 engineers and technicians were interviewed using a pre-prepared questionnaire that included questions on work experience, postgraduate training, qualification level, and workload. We also reviewed WHO and regional regulations regarding the professional descriptions and certification of biomedical engineers. The data were analyzed using SPSS Statistics 26, and the results are presented in figures and tables. Results: The study population comprised 72.4% males, 95.6% full-time employees, and 68.8% bachelor’s degree holders. However, the majority (90.4%) did not have a specialty degree. Regarding on-the-job and other training, 73.5% had not received any training. The training status of professionals was not dependent on the organization they worked for. However, there was a statistically significant difference between foreign training and manufacturer-provided training. The professionals surveyed had received relatively little training since they started working. As their years of experience increased, the number of manufacturer-organized training sessions also increased. However, there was no relation between years of experience and the number of domestic, foreign, or postgraduate training sessions. Additionally, the number of medical devices managed per engineer varied, and the legal framework regulating social security, rights, and obligations remains insufficient. It also varied compared to WHO recommendations, medical engineering professional descriptions, and certifications across countries in the region.Conclusion: Clinical engineers and technicians face a heavier workload. The lack of postgraduate training opportunities, an insufficient legal framework, and variations in medical engineering professional descriptions and certifications across countries in the region present significant challenges for the sector. Based on these findings, the study proposes strategic recommendations including legal recognition, certification systems, continuing professional development, and workforce planning policies to address these barriers and strengthen clinical engineering in Mongolia.