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医療機器といっても医師が使用する高度な機会とは違って、家庭用医療機器は薬事法の上ではクラス の 管理医療機器 に分類されています。 クラス の定義は、薬事法第２条 定義 ６項に この法律で 管理医療機器 とは高度管理医療機器以外の医療機器であって、副作用又は機能の障害が生じた場合において人の生命や健康に影響を与えるおそれがあることからその適切な管理が必要なもの とされています。 協会では、家庭用医療機器は 健康管理や疾病予防 治療等 に使用するものとして定義しています。 何かあったときには生命や健康に影響を与えるおそれがある と薬事法で定義されても、消費者が 自らの責任で選択し、購入して使用 しなければなりません。 家庭用医療機器には 承認 認証 番号 が割り振られています。 例えば、低周波治療器は効能 効果のひとつに 肩こりの緩解 かんかい とあります。 広告に効能 効果を謳いながらも承認 認証 番号がない家庭用医療機器には注意が必要ですね。 Return to page top.
