2018-12-17 15:45:06 - 8

CBR participates in a meeting at ANVISA on the revision of RDC 25/2001

The CBR, represented by Dr. Cibele Carvalho, director of Professional Defense, participated in the November meeting at ANVISA which discussed, among other matters, the issue of the sale of used equipment. RDC 25/2001 provides for the import, sale and donation of used and refurbished products aimed at the health segment. 16 Institutions participated, which were entitled to a presentation for 10 minutes to expose their positions on the subject, with an opening for questions afterwards. “Today, in Brazil, any sale of used equipment is prohibited, except when there is a reconditioning of the machine by the manufacturer who is the registration holder, which is practically impossible, as manufacturers prefer to sell new equipment than recondition a semi-new. In addition, the amount charged for reconditioning is very high, making this practice unfeasible. The manufacturer has also determined the useful life of the equipment, which often differs in other countries around the world”, explains Dr. Cybele Carvalho. Such points constitute irregularities, especially in relation to free competition. On the other hand, by conferring the monopoly on reconditioning to the manufacturer, the norm ends up restricting the right to ownership and to be able to enjoy, enjoy and dispose of the acquired good. After several presentations during the meeting, the polarization of the discussion between equipment manufacturers and other institutions became clear, as well as the need to change legislation so that the underprivileged population has access to new technologies through equipment donated or sold with more attractive values, but offering safety and quality. The possibility of reconditioning companies carrying out this reconditioning, providing guarantees of use, was also widely discussed. Some suggestions were pointed out, such as providing a report of full operation and not a reconditioning itself. Such a report could be provided by a duly qualified professional, other than the manufacturer or someone indicated by him. The traceability of the equipment by the manufacturer after being sold or donated would be maintained through ANVISA's control standards. “CBR's participation was fundamental, as we were the only medical society with the right to speak and debate, reinforcing the entity's role in the defense of Radiology and aiming at better assistance to the population”, concludes Dr. Cybele.