Importers of medical devices do not want agency that would certify these products
The importers of medical devices do not back the initiative to create an agency that would certify and register these products brought into Moldova, saying the equipment already has quality certificates from producers. The creation of such an agency is stipulated in a bill, Info-Prim Neo reports.
The bill was discussed in a meeting of the parliamentary commission on social protection, health and family on Tuesday. The commission’s head Vladimir Hotineanu, who is the author of the bill, said that Moldova now does not have a legal framework for implementing European standards in the field of medical devices and protection of the consumers of medical services. The bill was drafted with the aim of adjusting Moldova’s legislation to the European acquis, said the MP.
The bill says that the medical devices can be imported into Moldova and used only if they are certified and registered so as not to affect the patients’ safety and health. Vladimir Hotineanu said the bill will ensure the rational and uniform promotion of the policies on medical devices and this will contribute to increasing the cost-efficiency in using the money intended for modernizing the health system and to protecting the rights of the consumers of medical services.
Ghenadie Tanurcov, the head of the Association of Private Doctors, said the National Institute of Standardization and Metrology can examine these devices. It is true that it does not have the necessary equipment, but the new agency may also not have it, he stressed.
Andrei Botnaru, the representative of an importer, said that the medical devices are already certified and there is no need to create a certification agency. “We now have specialists who are doctors, but are not engineers. This bill is useless as the equipment needed to perform the necessary examinations is absent,” he said.
Vladimir Hotineanu replied that the Technical University of Moldova has a faculty where there are prepared specialists in biomedicine and in medical devices and there are persons who graduated from this faculty in 2010.
The given bill will be discussed again and possibly approved after it is improved.