Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

Japan · Last verified: 2026-09-08

Number

昭和三十五年法律第百四十五号

Type

Act

Issuer

日本国会

Status

in_force

Authority

PMDA / 厚生労働省

What this covers

日本医疗器械与药品的主干法（俗称药机法）。规定医疗器械的定义与分级、制造销售业许可、品种注册（承认/认证/届出）、上市后安全管理、广告与罚则，是日本器械准入的总法。

Source: e-Gov Law Search, Japan