Search
214 results for "="
HomeIFA Coding SystemUnique Device Identification (UDI)
Unique Device Identification (UDI)
”A worldwide system for unique identification of medical devices is introduced with European regulation EU 2017 745 on medical devices and EU 2017 746 on in vitro diagnostics IVDR It is based on the UDI unique device identifier a generic term for product“ ... more
HomeIFA for Data RecipientsData provisionDownload link
Download link
”Provision via a download link delivered to an email inbox Provision You will receive an email with a unique individual link for the provision of your Information Service on an internet storage of IFA GmbH The link downloads the delivery as a ZIP archive This delivery“ ... more
HomeFAQ
FAQ
”Are physician samples obliged to FMD? | Yes, physician samples according to AMG are, if the medicinal product itself is obliged to verification, also obliged to verification. They must be serialised just like any other sales pack. All four data elements must be uploaded“ ... more
HomeFAQ
FAQ
”From what point in time do I need a UDI-DI for my medical device? | With the date of the MDR's application on 26.05.2021, a UDI-DI must be assigned to each medical device. For in vitro diagnostic medical devices, this goes from the application of the IVDR (delegated act“ ... more
HomeLegal notice
Legal notice
”Informationsstelle für Arzneispezialitäten – IFA GmbH Hamburger Allee 26 – 2860486 Frankfurt am MainPhone: +49 69 979919-0Email: ifa@ifaffm.deInternet: https://www.ifaffm.de/enGeschäftsführer: Dr. Christian BachVorsitzender des“ ... more
HomeFAQ
FAQ
”What does notifying the attribute 'Verifizierung im Pflichtbetrieb ab Hochladedatum' mean – when and how do I notify it? | With the attribute Verifizierung im Pflichtbetrieb ab Hochladedatum the pharmaceutical entrepreneur determins the medicinal product's obligation to“ ... more
HomeIFA for Data RecipientsNew customersIFA information service – sample products
IFA information service – sample products
”Sample product 10228 is a data stock product i e it contains all data available in the IFA Database at the observation date Sample product 20228 is an update product It contains all new entries changes and deletions in the observation period Both products contain“ ... more
HomeIFA GmbHIFA current information
IFA current information
”27.12.2023 | Extensions of IFA Database as of 01 February 2024 | "... on publication date 01 February 2024 the IFA database will receive new and modified data fields for medicinal products. Relevant information on the changes and the need to notify your products“ ... more
HomeFAQ
FAQ
”Which documents and attributes do I have to submit for the first publication of physician samples into IFA’s Database? | In general, notifying physician samples is not treated differently to medicinal products of the type standard. The following documents have to be“ ... more
HomeFAQ
FAQ
”What special rules apply to the marketing of sterile medical devices? | According to DIN 58953-8:2010-05, sterile medical devices should be delivered, transported and stored in a so-called packaging system, consisting of a primary (sterile barrier system) and an“ ... more
Document Finder