SERVICES
Medical Devices
We offer senior advice in technical and legal procedures for the biosanitary and Medical Devices industry. We advise you and perform any procedure related to this products in general, and for IVDs (In Vitro Diagnosis).
Authorization for the facilities of manufacturing / importing companies
Companies that carry out any of the activities of manufacturing, importing, grouping and/or sterilizing Medical Devices must have an authorization for their facilities, granted by the General Subdirectorate of Health Products of the AEMPS.
Registration of distribution companies
Companies that distribute Medical Devices must make a Communication, or request an Authorization (depending on the Autonomous Community) to the Health Authorities of the Autonomous Community where the company is located.
Technical File for Medical Devices
Preparation of the Technical Dossier or Technical Documentation for Medical Devices, according to the new Regulation (EU) 2017/745, both for self-certified class I products and for products that require CE certification by a Notified Organism.
Marketing communications
We carry out the necessary procedures for the registration and marketing of Medical Devices (marketing communications)
Authorization for Medical Devices Advertising
In GTF M. Camps, we advise you and cover your needs regarding the preparation and presentation of the request for advertising aimed at the public to the competent Health Authorities.
Did you know that...
- There are more than 500,000 products based on medical technologies. You can find Medical Devices in hospitals, social services and in your own home.
- The European Healthtech directly employs more than 760,000 people. By comparison, the European pharmaceutical industry employs around 795,000 people.
- Germany is the country with the highest number of people employed in the sector, while the number of medtech employees per capita is higher in Ireland and Switzerland.
- In Europe there are more than 33,000 medical technology companies. The largest number of them are also based in Germany, followed by Italy, the United Kingdom, France and Switzerland.
- Small and medium-sized enterprises (SMEs) make up about 95% of the technology industry, most of which employ fewer than 50 people.
- In the European Union, an average of approximately 11% of the Gross Domestic Product (GDP) goes to healthcare, a clearly pioneering, fundamental and constantly growing sector.
