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The document appears to be a collection of hyperlinks to various forum posts on different Vietnamese websites. While the actual content of the forum posts is not viewable, the URLs and titles suggest the posts are discussing renting out photocopy machines for office use. In summary, the hyperlinks reference multiple online discussions around renting photocopy equipment to offices across several Vietnamese discussion forums and marketplaces.
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Introduction
Classed as innovative and efficacy-impaired, IMDs are put under extreme scrutiny from regulatory authorities because the devices essentially affect the health of patients. Under the auspices of the above, different regulatory frameworks in Europe such as the European Union Medical Device Regulation (EU MDR 2017/745) and in America such as the Food and Drug Administration (FDA) have imposed their own sets of strict regulations concerning the design, manufacture, clinical evaluation, and post-market surveillance of these devices.
Hence, the manufacturers must demonstrate compliance with essential safety and performance requirements and perform all necessary risk assessments, with solid clinical evidence presented for the protection of the patients. Furthermore, the AIMDs would need a long list of tests including but not limited to biocompatibility tests, electromagnetic compatibility tests, and long-term reliability studies to extend support to their lifetime and functioning.
Continuous changes are currently being witnessed in AIMDs owing to their inherent complexities and ongoing innovative materials, miniaturization, and wireless technology advancements aimed at enhancing patient outcome and quality of life.
Due to the high-risk classification of AIMDs, regulatory authorities across the world implement strict guidelines. AIMDs are classified as devices with the highest risk category, thus calling for enhanced scrutiny for any evaluation assessment.
Technical documentation is extensive and a requirement by manufacturers, examples are the clinical evaluation report, the risk management file, and the post-market surveillance plan under EU MDR. AIMDs shall always be assessed by a notified body (NB) prior to CE marking under EU MDR.
Under the United States, FDA regulation majority of AIMDs require a PMA submission whereby they must demonstrate safety and effectiveness under clinical trials. Investigational device exemption (IDE) permits AIMDs to be used in clinical studies prior to being fully approved. AIMDs must be plainly identifiable in order to assist safety monitoring so they must have a UDI carrier.
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