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Quality of imported medical devices to be monitored based on new law


https://www.ipn.md/en/quality-of-imported-medical-devices-to-be-monitored-based-on-7967_1035024.html

The business entities will be able to bring only high-quality and safe medical equipment into the country. At the same time, all the diagnostic and treatment devices will be periodically tested to avoid medical errors and incidents in the process of investigating patients and performing medical procedures. The measures are stipulated in the Law on Medical Devices that was adopted by Parliament in the final reading on June 9, IPN reports.

Deputy Minister of Health Liliana Iasan said that owing to this law the import or use of medical equipment of a poor quality in the Republic of Moldova, which endangers the patients’ health, will be impossible. Also, the quality of equipment certified by the European community will be immediately recognized, while the registration procedure for equipment made in other states was simplified.

The law also provides that the used medical devices will be tested periodically. In parallel with the carried out tests, the process of managing the equipment will be monitored through the information medical devices management system. This is a database implemented at public medical institutions, the Ministry of Health and the Agency for Medicines and Medical Devices. The system will ensure the observance of the rules concerning the correct use of equipment.

The law was drafted by the Ministry of Health and represents a novelty for Moldova. It is also a measure defined in the national plan of action for implementing the Moldova – EU Association Agreement.