『保健医療科学』 2022 第71巻 第2号 p.156-162（2022年5月）
特集：最近の薬事行政の話題と改正GMP省令について <総説>
医療機器規制の概要と最近の取組み
村上まどか
厚生労働省医薬・生活衛生局医療機器審査管理課プログラム医療機器審査管理室
Overview of medical device regulations and recent updates
MURAKAMI Madoka
Office of Software as a Medical Device Evaluation, Medical Device Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare
抄録
平成25年に薬事法(昭和35年法律第145号)が改正され，医薬品，医療機器等の品質，有効性及び 安全性の確保等に関する法律と名称を変え，さらに令和元年にも改正がなされた.これらの改正では，医療の目的を持つ単体プログラムをプログラム医療機器として位置付け規制の対象とし，また，革新的な医療機器へのアクセス改善を目的とした承認プロセスの迅速化や，プロダクトライフサイクルの早いプログラム医療機器を含む医療機器の変更の手続きを合理化するための制度が法制化された.
本稿では，本邦における医療機器規制の概要を説明するとともに，令和元年の法改正による法規制のうち，患者アクセスの迅速化に資するものとして「先駆的医療機器指定制度」，「特定用途医療 機器指定制度」，「条件付き承認制度」，「医療機器の特性に応じた変更計画の事前確認制度」(通称: IDATEN(Improvement Design within Approval for Timely Evaluation and Notice))について解説する. また，プログラム医療機器に関して，「経済財政運営と改革の基本方針2021」(令和3年6月18日閣議決定)等において承認審査の迅速化を図ることとされたことを受け，厚生労働省が令和2年11月に公表した「プログラム医療機器実用化促進パッケージ戦略」(通称:DASH for SaMD，DX(Digital Transformation)Action Strategies in Healthcare for SaMD(Software as a Medical Device)に基づく取組みについて説明する.
キーワード: 医療機器規制，先駆的医療機器，変更計画，特定用途，条件付き承認，プログラム医療機器
Abstract
In 2013, Pharmaceutical Affairs Law (Act No. 145 of 1960) was amended and changed its name to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Then there was another amendment to the act in 2019. In those amendments, standalone software intended for medical use which is called Software as a medical device (SaMD) was subject to the medical device regulations and processes which enable patients to access earlier to the medical device with cutting-edge technology were enshrined in to law. The system to streamline the change process for medical devices including SaMD which have shorter product life cycle was also legalized.
This report describes the overview of medical device regulations in Japan and some of the review systems adopted in the amendment of the act in 2019 including “Sakigake designation system”, “priority review for specific use of medical devices”, “conditional approval system” “Post-Approval Change Management Protocol (PACMP)” (So-called IDATEN (Improvement Design within Approval for Timely Evaluation and Notice)) for early patient access. This report also overviews current efforts based on “DASH for SaMD”(DX (Digital Transformation) Action Strategies in Healthcare for SaMD) which Ministry of Health, Labour and Welfare has published in November 2020, reflecting the governmental policy to accelerate the premarket review of SaMD which is mentioned in the Basic Policy of Economic and Financial Management and Reform (decided by the Cabinet on June 18, 2021).
keywords: Medical Device Regulations, Sakigake Designation system, PACMP, priority review for specific use medical devices, conditional approval system, SaMD
