Asturex informs companies about the legal requirements for exporting medical devices to the United States

Webinar in collaboration with Kaeltia Consulting

The webinar also offered information about all product procedures before the FDA and the registration and list of exporters, in addition to answering the individual questions of each participant.

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With the aim of informing Asturian companies about the conditions and legal requirements for the export of medical devices to the United States, Asturex organized, on June 12, a webinar in collaboration with Kaeltia Consulting, focused on the requirements that this type of products must meet before the United States Food and Drug Administration (FDA).

For the FDA, a medical device is an instrument, apparatus, machine, implant, diagnostic reagents, software or any other item used for the diagnosis, treatment or prevention of disease in humans, or to modify the structure or function of the body. This includes everything from simple medical supplies to complex diagnostic systems and surgical equipment. Hence the importance of knowing all the regulations that the regulatory entity requires of equipment imported into this market.

The 13 participating companies highlighted the importance of this day in which Dr. Elisa Capellán Montoto, CEO and senior consultant of Regulatory Affairs, reviewed the different categories of medical devices, labeling standards and import requirements, among other notable topics. .