ASEAN 医療機器指令の概要と各国の 対応状況向調査 - JETRO
プロセスが一定程度整合されること、統一申請様式(Common Submission Dossier Template、 以下CSDT)を活用した申請が可能となることは、労力・時間・コストを削減する点で大き なメリットとなります。一方、現状では、各国のAMDD へ準拠した法令や許認可プロセス
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