Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

Japan · Last verified: 2026-09-08

Number

昭和三十六年厚生省令第一号

Type

Regulation

Issuer

厚生労働省

Status

in_force

Authority

PMDA / 厚生労働省

What this covers

药机法施行规则（省令）。规定医疗器械制造销售业/制造业许可申请、承认与认证申请的具体材料与程序、标签记载、不良事件报告等操作层要求。

Source: e-Gov Law Search, Japan