NEWS on implant administration
Germany: Specialty association certifies cochlear implant centers
According to the professional association, around 50,000 people in Germany are deaf, and another 250,000 have at least a 50 percent hearing impairment. If sufficient understanding of speech is not possible with a hearing aid, a CI can restore hearing and understanding in many cases. A CI is not an...
Paris court awards compensation to women for faulty breast implants
For years, the now insolvent manufacturer PIP had produced implants that were susceptible to rupture. The testing organization TÜV Rheinland had certified the process. A French court has now granted compensation to the complainants. The Paris Court of Appeal on Thursday condemned the testing organization TÜV Rheinland for lack of...
FDA’s “Data Effect” Tsunami – Steps To Prepare
The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan (TMAP). Announced on March 3, 2021, DMAP is the agency’s overhaul of technology and data with the objective of bringing together increasingly disparate and diverse data sources to help understand and pinpoint emerging...
A Road Map To China’s Medical Device Registration Process
China has one of the most promising medical markets and its healthcare industry is currently the second largest in the world, following closely behind the U.S. From 2015 to 2019, the CAGR for the Chinese medical devices market has increased significantly, and it is expected to continue rising even more in the...
EU CED: Implantatpass für Zahnimplantate
Das Council of European Dentists beschloss, dass gemäß Medizinprodukteverordnung einem Patienten ein Implantatpass auszuhändigen ist. Dieser soll das Implantat eindeutig identifizieren. Gesundheitsdienstleister werden verpflichtet den Patienten einen solchen Ausweis auszuhändigen. Implant-Register: Der einfachste Weg ist es, den Implantatpass im Register herunterzuladen und auszudrucken. Der download ist hier.
EU CED: Implant certificate for dental implants (passport)
The Council of European Dentists decided in 2020 that, according to the Medical Devices Regulation, an implant passport must be given to a patient. This should clearly identify the implant. Healthcare providers will be obliged to provide patients with such a passport. Implant Register: The easiest way is to download...
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