Licenses and authorizations for the manufacture, distribution and commersialitation of medical devices.
According to Real Decreto 1591/2009, a medical device is any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such mean. In parallel, exists the legislation applied to in vitro diagnostic medical devices and to active implantable medical devices.
Urdí-Solé & Associats, S.L. offers the service to process the following procedures in the medical devices area:
- License for the Manufacture and/or Import of Medical Devices.
- Communication of the activity of distribution and/or sell of medical devices.
- Responsibles Register of Medical Devices Class I, Custom-made devices and in vitro Diagnostic Medical Devices manufactured in Spain.
- Communication of commercialisation of a medical device.
- Communication of commercialisation of medical devices IIa, IIb y III, active implantable medical devices and in vitro Diagnostic Medical Devices included in Annex II of Real Decreto 1662/2000 and modifications.
- Inclusion of a Medical Device in the Reimbursement System of the National Public Health.
- Processing of National Code for medical devices commercialized in the pharmacy channel.