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(Common Submission Dossier Template) based on the provisions of AMDD. With the implementation of AO 2018-0002, the FDA through the Center for Device Regulation, Radiation Health and Research (CDRRHR) is also mandated to release list of medical devices per classification based on the classification set forth in the ASEAN AMDD.

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  Dossiers, Template, Common, Submissions, Common submission dossier template

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