For a medical device to be marketed in Spain or Portugal, it is necessary to have the CE marking with a Notified Body established in the EU and request its registration from the competent national authorities. This is: Spanish Agency for Medicines and Health Products (AEMPS) in Spain or Instituto Nacional da Farmacia e do Medicamento (INFARMED) in Portugal. ​ To Whom Our Services Are Directed? We add value to distribution and import companies with and without a warehouse that commercialize or want to commercialize finished products that have all the necessary certificates for their placing on the market and especially the CE marking. ​ How Do We Manage Your Medical Device Regulatory Affairs Department? ​ To carry out all the necessary procedures with the Spanish and Portuguese health administrations so that the product has access to the market in the shortest possible time with full health guarantees. ​ To carry out the procedures aimed at obtaining import license. ​ To develop, implement and monitor the surveillance system: -  Carry out the internal audits that the system indicates and that of your            supplier companies. -  Manage claims, withdrawals, no-conformities, etc. -  Prepare an annual plan for the training periods, providing initial and                ongoing training to company personnel involved in product quality                  processes, as well as training new employees. ​ In order for GAILUMED to conclude that a product can be marketed, it must be safe, effective and of quality. For this reason, it is very important to take into account the classification of medical devices based on the degree of invasiveness on the person. The greater the invasion into the human body, the greater is the risk clasification. ​ GAILUMED puts at your disposal specialists in the matter who will act as interlocutor personnel before the health authorities, carrying out the administrative procedures necessary to obtain import licenses and the communication of the placing on the market of medical devices. ​ We found four classes of risk: CLASS I Products that only come into contact with the patient topically or through a natural orifice such as the nose and mouth for a limited time. ​ CLASS I STERILE They follow the previous rule, are always single use and come in containers that guarantee sterilization. In this category we can find examination gloves, syringes or surgical instruments (the only case reusable by prior sterilization after previous use). ​ CLASS I WITH EDIT FUNCTION The previous rule continues to be applied, presenting these the variety of their use. For example: non-electronic thermometers or tonometer’s. ​ CLASS IIa SIncluded in this class are medical devices that are introduced into the human body through a body orifice or by surgical means (through the skin) but are not intended to remain within the patient. Likewise, we will include in this class those that supply energy or substances or those that modify physiological processes. Examples: probes, cannulas, catheters, surgical gloves, among others. ​ CLASS IIb EIn this class, the risk increases due to the greater potential for danger in its use or remain inside the body for a long time. Examples: intraocular lenses, blood bags, surgical lasers, among others. ​ CLASS III In this class we already mentioned surgical implants for therapy or diagnosis. Some contain drug. Examples: Heart valves, implantable prostheses, condoms with spermicide, among others.    SUBGROUP OF CUSTOM MADE MEDICAL DEVICES They are medical devices that are implanted in the human body and produce an activity generally through an energy source (pacemakers or defibrillators). ​ These are intended for clinical research, self-diagnosis, “In vitro” diagnosis (IVD) and active implants. What Is A Medical Devices Import License? It is a license that authorizes the holder, for a specified period, to import certain medical devices from countries outside the EU under the control of the Responsible Technician. ​ The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, is the body that grants these licenses to comply with the legislation for the import of health products. ​ The duration of the license for the importation of medical devices is 5 years, after which it must be renewed if you want to continue importing.