Services for Spain
We study your company's needs and provide you with a department that will manage all regulatory matters for the marketing of your medical devices in Spain.
REGULATORY AFFAIRS MANAGEMENT FOR MEDICAL DEVICES
For a medical device to be marketed in Spain, it must have the CE marking from a Notified Body established in the EU and must apply for registration with the competent national authorities. This is the Spanish Agency for Medicines and Medical Devices (AEMPS). GAILUMED provides specialists in the field who will act as contacts with the health authorities, carrying out the necessary administrative procedures for obtaining import licenses and communicating the marketing of medical devices. Who are our services aimed at? We provide value to distribution and import companies with or without a warehouse that market or wish to market medical devices that have all the necessary certifications for marketing, especially the CE marking. For GAILUMED to conclude that a product can be marketed, it must be safe, effective, and of high quality. For this reason, it is very important to consider the classification of medical devices based on their degree of invasiveness. The greater the invasion into the human body, the higher the risk classification. There are four risk classes: 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 These follow the previous rule: they are always single-use and come in packaging that guarantees sterilization. In this category, we can find examination gloves, syringes, or surgical instruments (the only case reusable after prior sterilization after one previous use). CLASS I WITH EDITING FUNCTION The previous rule still applies, but these present a variety of uses. For example: non-electronic thermometers or tonometers. CLASS IIa This class includes medical devices that are introduced into the human body through a body orifice or surgically (through the skin), but are not intended to remain inside the patient. Likewise, we will include in this class those that supply energy or substances or that modify physiological processes. Examples: probes, cannulas, catheters, surgical gloves, among others. CLASS IIb In this class, the risk increases due to the greater potential for danger when used or when left inside the body for prolonged periods. 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 drugs. Examples: heart valves, implantable prostheses, condoms with spermicide, among others. CUSTOMIZED MEDICAL DEVICES SUBGROUP These are medical devices that are implanted in the human body and produce activity, generally through an energy source (pacemakers or defibrillators). They are intended for clinical research, self-diagnosis, in vitro diagnostics (IVD), and active implants.
TECHNICAL ADVICE
IN REGULATORY MATTERS
We put our Regulatory Affairs department at your disposal to cover the needs of your company, thus resolving any eventuality that may arise.
Specialized technical advice on Regulatory Affairs.
Lack of technical personnel due to business volume, sick leave or vacation.
LICENCIA DE IMPORTACIÓN
PARA PRODUCTO SANITARIO
We prepare applications for import and distribution licenses for sanitary products, IVD, biocides for the Spanish, Portuguese and European markets.
Product's import licenses
We draw up the SOPs (standard operating procedures) and process the application for the different licenses required (for health products, including IVD, biocides and cosmetics) by the AEMPS (Spanish Agency for Medicines and Health Products).
Distribution of sanitary products
We process the request for the authorization of distribution of products to the health authorities in the CCAA (Autonomous Communities).
We carry out the communication of placing on the market of SP (Sanitary products) to the AEMPS, for risk classes 2a 2b and 3.
We assist in the monitoring and traceability of a product by providing reports of market behavior to its manufacturer.
EEC MARKING
When a medical device manufacturer wants to enter the European healthcare market, they must comply with a series of standards and requirements, both for themselves and for the products they wish to market. Specifically, they need to obtain the CE marking for their medical devices, as without it, they will not comply with current regulations. What is the CE marking? Many people may think that the CE marking on a medical device shows that it was manufactured in a European Union country. However, the CE marking verifies that the product has undergone a series of tests and inspections to ensure it meets the quality, safety, and efficacy requirements established by the regulations. This way, the product can be marketed throughout Europe without any problems. Something to keep in mind is that depending on the country where the product will be marketed, the health laws that govern it may be different from those in another country. Therefore, the CE marking regulations allow the requirements of all European Union member countries to be better encompassed. Which countries use the CE marking? Since the CE marking is required for the consumption of products in European Union member countries, all member countries must obtain it. Other countries such as Iceland, Norway, and Liechtenstein must also be included in this list. On the other hand, we must keep in mind that many of the companies that market these types of products, despite being European, may have their factories or subcontract to a manufacturer located on the other side of the world, such as any country in Asia. Therefore, it is necessary for both the contracting company and the manufacturer to ensure that the products ultimately marketed comply with CE regulations and can be sold without any risk of penalties. What standards are used to base the CE marking? As we have mentioned, the product that will subsequently be marketed does not necessarily have to have been manufactured in a European Union country, so the importing country must ensure with certainty that the company that carried out the entire manufacturing process complied with the CE marking regulations. In the event of a problem, we can consider two different situations. On the one hand, the importing company will only be the distributor of the product among the different European countries, and in the event of a problem with the CE marking, the manufacturer will be responsible for the problem, as the specifications regarding the CE marking regulations must be clearly stated in the order form. On the other hand, if the importing company uses its own name when naming and marketing the product, they themselves will be responsible for the manufacturer's responsibilities. Regarding the standards that must be met to obtain the CE marking, we find: - Product manufacturers must independently investigate the CE marking regulations in each country in order to comply with the established conditions. - The final product may only be marketed if the established requirements are met and the process is carried out appropriately in terms of time and form. - The manufacturer will be responsible for adding the CE marking to the product. - To avoid any problems and ensure that the process has been carried out correctly, the company itself may hire another evaluator to ensure that the manufacturer's assessment is satisfactory and that there will therefore be no problems later when selling the products. - It is essential that once the product has the CE marking, even if new controls are carried out or a new label with a different meaning is applied, the CE marking must always be clearly visible. When obtaining the CE marking, are there any fees to pay? As with liability, we can consider two different scenarios. On the one hand, if the company that will market the product is responsible for its manufacture, it has the option of carrying out all the necessary procedures to comply with CE marking regulations. However, if the product is manufactured by another company, it must hire a notified body to carry out this task; therefore, this service will have to be paid for, either directly or indirectly. How should the CE marking be placed on the product? As we mentioned above, the main requirement once we have the CE marking on the product is that it can be clearly and legibly observed. However, depending on the product, we may encounter different situations: - The size of the CE letters may change depending on the size of the product, which is irrelevant as long as the size of both letters is the same. - In some cases, it is not possible to place the CE marking on the product itself, so an alternative solution must be found. For example, there are some products that cannot be CE marked, but since they are packaged, the symbol can be placed on the packaging itself. Even if packaging is not available, it would be possible to place the symbol on any type of document accompanying the product. - Although the CE marking can vary in size, although the letters must always be in the same proportion, the maximum size that the symbol can be is 5 mm. A different size may be possible, but only if it is specified within the CE marking regulations for that particular product.