Ministry of Health investigates AMDM for alleged regulatory irregularities
Accusations of favoritism and unfair competition have led the Ministry of Health to conduct thorough checks at the Agency for Medicines and Medical Devices (AMDM). Ordered on Monday, July 27, the inspection focuses on the registration of medical devices, as well as the circumstances surrounding the agency's decision to withdraw an appeal in a case involving two types of catheters that were banned in 2024.
According to the Ministry of Health, at the request of Minister Alexandru Gasnaș, a control will be carried out regarding the management of medical device evaluation and registration files, compliance with the order of their examination and the legality of contracts concluded with external experts.
At the same time, the reasons why AMDM did not challenge the court decision in the file regarding two types of catheters previously banned will be verified.
The ministry also ordered an emergency assessment of information regarding the quality of intravenous catheters used in pediatric medical institutions in Chisinau. The hospitals concerned will be requested to submit reports and notifications regarding any problems; samples will be taken, and the authorities will identify an accredited laboratory to test the devices.
In parallel, the conflict of interest and confidentiality declarations of specialists involved in the evaluation of medical devices will be analyzed.
"The results of the checks will be made public. Depending on the findings, the measures provided for by law will be applied, and the information falling within the competence of law enforcement bodies or integrity authorities will be transmitted to them", the Ministry of Health reports, which requests medical personnel to report, through the vigilance system, each case in which medical devices with possible quality deficiencies are identified.
The Republic of Moldova cannot test medical devices
The control ordered by the Ministry of Health follows the publication of an investigation that reported possible irregularities in AMDM's activities. The material refers to complaints by medical personnel from children's hospitals in Chisinau regarding the quality of intravenous catheters used, as well as to a dispute in which AMDM gave up challenging the decision of the first instance after, in 2024, it banned the use of two types of catheters due to alleged quality defects. The ban was later cancelled.
The investigation also challenges the way in which medical devices are evaluated and registered and points to possible conflicts of interest within AMDM.
The Ministry of Health has stated that the Republic of Moldova currently lacks the capacity to fully test medical devices at the national level. As a result, a significant portion of the evaluation process depends on the documentation submitted by manufacturers.
In light of this, the authorities have announced their intention to develop a phased reform plan within the next 60 days. This plan aims to strengthen testing capacity for medical devices by collaborating with accredited laboratories in the European Union. Additionally, it will focus on digitizing the registration process, ensuring electronic traceability for each file, establishing a clear and verifiable mechanism for the examination of medical devices, separating the registration process from public procurement procedures, and enhancing the national vigilance system through regular reporting of incidents and the measures taken in response.
According to the Ministry, the reform plan will outline specific implementation deadlines, identify responsible institutions, and detail any financial requirements.
