At the same time, Health Minister Alexandru Gasnash ordered a thematic audit of the Agency for Medicines and Medical Devices (AMDM) following press reports about the agency’s activities. The audit will cover the procedures for reviewing and registering medical devices, compliance with the order of priority for reviewing relevant dossiers, and the legal basis for entering into contracts with external experts.
The Ministry will also review the conflict-of-interest and confidentiality declarations submitted by specialists involved in the evaluation of medical devices, including those who simultaneously work at other institutions within the healthcare system.
The results of the audits will be made public. Depending on the findings, the authorities will take the measures provided for by law, and materials falling within the jurisdiction of law enforcement agencies or integrity bodies will be forwarded to the appropriate agencies.
Within 60 days, the Ministry of Health will present a phased reform plan aimed at strengthening national capacity for testing medical devices, including through cooperation with EU-accredited laboratories, the digitization of the registration process and the assurance of electronic traceability for each dossier, the implementation of a transparent and verifiable document review procedure, the functional separation of medical device registration and public procurement processes, and the strengthening of the national incident monitoring and reporting system. The plan will specify implementation deadlines, responsible agencies, and the necessary funding.
The decision was made following the publication on Monday of a journalistic investigation alleging that the catheters in use may be of poor quality. In addition, the report details alleged violations that are said to have been committed at the highest levels of the Agency for Medicines and Medical Devices.
