プログラムの医療機器該当性に関するガイドライン
厚生労働省は、2021年3月31日付で「プログラムの医療機器該当性に関するガイドライン」(薬生機審発 0331 第1号/薬生監麻発 0331 第 15 号)を発出した。
本ガイドラインではどのようなプログラムが医療機器に該当するのか/しないのかを判断するための基準を示している。
医療機器該当性について医療機器に該当するプログラム
ガイドラインでは、医療機器に該当するプログラムとして以下が挙げられている。
1. 入力情報を基に、疾病候補、疾病リスクを表示するプログラム
2. 疾病の診断・治療・予防を意図したプログラム
- 医療機器で得られたデータ(画像を含む)を加工・処理し、診断又は治療に用いるための指標、画像、グラフ等を作成するプログラム
- 治療計画・方法の決定を支援するためのプログラム(シミュレーションを含む)
- 医療機器の制御を行うプログラム、又は、医療機器データの分析を行うことを目的として、医療機器に接続して医療機器の機能を拡張するプログラム
3. 有体物の医療機器とセットで使用するプログラム
医療機器に該当しないプログラム
また、医療機器に該当しないプログラムとして以下が挙げられている。
1.個人での使用を目的としたプログラム
- データの加工・処理を行わない(表示、保管、転送のみを行う)プログラム
- 運動管理等の医療・健康以外を目的としたプログラム
- 利用者への情報提供を目的としたプログラム
2.医療関係者が使用することを目的としたプログラム
- 医療関係者、患者等への医学的判断に使用しない情報提供のみを目的としたプログラム
- 院内業務支援、メンテナンス用プログラム
- データの保管、転送のみを行うプログラム
- 診断、治療以外を目的とした、データの加工・処理を行うプログラム
- 診断・治療ガイドライン等に従った処理のみを行うプログラム
3.一般医療機器(クラスⅠ医療機器)と同等の処理を行うプログラム(機能の障害等が生じた場合でも人の生命及び健康に影響を与えるおそれがほとんどないもの)
プログラム医療機器に関する相談窓口
ガイドラインが発出されたものの、個別具体的な製品に関して、それが医療機器に該当するのか否か迷うこともあるだろう。
厚生労働省は、2021年4月1日よりプログラム医療機器の開発を目指す事業者を対象とする各種相談(プログラムの医療機器該当性に関する相談、プログラム医療機器の薬事開発に関する相談及び医療保険に関する相談)を受け付ける相談窓口を開設している。
相談窓口に関してはこちらの通知を参照されたい。
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