ENFORCEMENT RULE OF THE MEDICAL DEVICES ACT

Korea · Last verified: 2026-09-08

Number

2026년 2127호(총리령)

Type

Regulation

Issuer

국무총리(식품의약품안전처)

Status

in_force

Authority

MFDS

What this covers

医疗器械法施行规则（总理令）。规定品目许可/申报的申报材料、技术文件、GMP 审查、变更与再审查的具体操作要求，是韩国注册实务最常查的一部。

Source: e-Gov Law Search, Japan