We provided assistance to Draeger Peru regarding and administrative sanctioning proceeding for spare parts of medical devices. In this case, the competent regulatory authority (DIGEMID) took an arbitrary position, and our defence consisted of demonstrating the legality of obtaining the sanitary registration and the compliance with the applicable regulations. The case has been complex since it involved the deep understating of the functioning of the medical devices that were questioned, and the special regulation applicable to such devices. For this effect, we had to work directly with the technicians’ experts of the client, to describe the exact composition of the parts objected by the authority, its functions on the equipment, determine if they could be considered as perishables parts or not, or if they are just replacements of the equipment. With that analysis we were able to structure the position and defence of our client. This was a case without much prior pronunciations of the authority, and in that sense imply not only a defence argument position, but also an explanation of the equipment, parts, and functionality, from a legal perspective supporting our position
We have also represented our client in the hearing held to defend our position, with favourable results.
The case is pending to be resolved.
