In Ukraine came into force the new technical regulations for medical devices

Since July of 2017 entered into force the decree of the Cabinet of Ministers of Ukraine, which approved the new technical regulations for the importation of medical equipment. Now to import and sell medical equipment on the territory of our country can only official distributors, and the quality of the product confirms the Declaration of conformity.

As experts explain, earlier, to bring equipment into Ukraine, any product required certificate of registration and certificate of conformity. Now the procedure has changed somewhat. If the product belongs to the first class security (equipment low risk), you must obtain the Declaration of conformity of such products with the technical documentation generated in accordance with the technical regulations.

Medical products of other classes are subject to more stringent control. After collecting the documents the manufacturer shall apply to the certification bodies who assess the quality of the equipment. This process can be quite lengthy and must be repeated for each consignment. But the procedure ensures product quality and safety of medical products for doctors and patients.

“The introduction of the control system guarantees the production of quality products, what interested any consumer,” – says the auditor of the conformity of medical devices with technical regulations to LLC “Ukrainian center for medical certification and prognostication” Alla Asaulenko.

The new technical regulations import of medical equipment designed to protect patients from non-certified products, which had previously been used and enters Ukraine from abroad. Due to the low value of the old equipment is in demand in the market, though it has no guarantees from the manufacturer. But now to the documents in its import would be impossible.

One of the largest world manufacturers of medical equipment Toshiba Medical supplies to the Ukrainian market new devices and also offers a quality alternative b/a products – restored technique of “Secondlife”. The software “Secondlife” provides the factory restore the devices that were already in use.

Devices that are returned in the hands of Toshiba Medical, completely subject to verification at the manufacturer’s works and all components of such equipment inventoryservice and recorded. Only then starts the procedure of recovery. Thus, for example, ultrasound machines, computer and magnetic resonance tomographs can live your second life with the updated software and parts.

The equipment is made in Japan and restore in Denmark at the factory Toshiba Medical Systems Europe. Devices are tested for performance and quality in accordance with industry standards. Just check program includes more than 30 items. In the process of rebuilding the company uses only original spare parts and new sensors for ultrasound machines. After repair and cleaning restored equipment does not differ from new, but it comes on the market but at a more attractive price for the consumer. In addition, the manufacturer gives her annual factory warranty and assumes responsibility for completing the necessary verification procedures.

“Toshiba Medical accessibility does not mean loss of quality. Thanks to the program “Secondlife” medical equipment remains high-quality and modern, and has a factory warranty from the manufacturer. Its price is available that guarantees Ukrainians the opportunity to receive a quality medical examination”, – explains Oleg Sweet, Director of the company “INMED UKRAINE”, the official distributor of Toshiba Medical in Ukraine.