Medical devices and medical device manufacturers must register with various registries and databases worldwide. Some of these registrations, such as in the European EUDAMED, the US Food and Drug Administration (FDA) or the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA), are obligatory and must be carried out before marketing in the respective market.
Other registrations and listings, such as in the German list of aids (Hilfsmittelverzeichnis , HMV), the French „List of Reimbursable Products and Services“ (LPPR), the Italian „Repertorio“ and many more, can only be applied for after the product has been placed on the market. Regardless of the registration or listing, each institution involved in registration requires individual proof of qualifications and safety. This concerns your organisation, your staff and your medical device(s).
