医療機器プログラムに該当するかどうかの判断

医療機器プログラムに関するパブコメ募集

「プログラムの医療機器該当性に関するガイドライン」に関するパブリックコメントの募集がされている。
期間:令和3年2月3日~3月4日
医療機器の機能を有するプログラムは平成25年の薬事法(現在の薬機法)改正に伴い、医療機器として規制を受けることとなった。本ガイドライン(案)はどのようなプログラムが医療機器として規制を受けるのかについて示したものである。

医療機器プログラムとは?
原則として、以下を満たすものが医療機器として規制を受けるプログラムに該当する。

【性質】
疾病の診断、治療等に寄与するなど、医療機器としての目的性を有しており、かつ、意図したとおりに機能しない場合に患者(又は使用者)の生命及び健康に影響を与えるおそれがあるプログラム

【形態】
1. インストール等することによってデスクトップパソコン等の汎用コンピュータ又はスマートフォン等の携帯情報端末(以下「汎用コンピュータ等」という。)に医療機器としての機能を与えるもの
2. 有体物である医療機器と組み合わせて使用するもの

医療機器に該当するかどうかの判断
以下に該当するプログラムは医療機器に当たらない。
1.患者説明を目的とするプログラム
2.院内業務支援、メンテナンスを目的とするプログラム
3.使用者(患者や健常者)が自らの医療・健康情報を閲覧等することを目的とするプログラム
・個人の健康記録を保存、管理、表示するプログラム
・スポーツや健康維持を目的とするプログラム
4.生命及び健康に影響を与えるリスクが低いと考えられるプログラム(クラスⅠ医療機器に該当するプログラム)

具体的な判断に関しては、本ガイドライン(案)の別添資料およびフローチャートをご確認されたい。

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