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It is possible to convert air crew licences issued by other ICAO member states ("third countries") to an EASA licence. The applicant must have a valid third country licence and valid medical certificate. They must also hold a valid EASA medical certificate. They must pass all fourteen EASA theoretical exams.
The EUropean DAtabase on MEdical Devices (EUDAMED) is a database to collect and publish information on medical devices and in-vitro-diagnostica. EUDAMED has six modules: Actors registration; UDI/Devices registration; Notified Bodies and Certificates; Clinical Investigations and performance studies; Vigilance and post-market surveillance; Market ...
EASA member states include all European Union member states, as well as the members of the European Free Trade Association, i.e. Liechtenstein, Norway, Switzerland, and Iceland, which have been granted participation under Article 129 of the Basic Regulation (Regulation 2018/1139) and are members of the management board without voting rights. [4]
The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007 .
First Databank (FDB) is a major provider of drug and medical device databases that help inform healthcare professionals to make decisions. [1] FDB partners with information system developers to deliver useful medication- and medical device-related information to clinicians, business associates, and patients.
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Added two types of annual fees: establishment registration fee and product fee 2012: MDUFA III: Safety and Innovation Act of 2012: Expanded the definition of establishments subject to a registration fee, thus increasing the applicable device establishments paying the fee. 2017: MDUFA IV: FDA Reauthorization Act of 2017
On Dec. 6, the family received a phone call from immigration authorities and they were told to report to an office in Greenspoint, Texas, four days later to discuss Salazar-Hinojosa's case ...