Enforcement Regulations (PMD Act)

What the Enforcement Regulations cover

The PMD Act Enforcement Regulations (薬機法施行規則 / Yakki-hō Shikōkisoku) are a Ministerial Ordinance-level instrument that provides the procedural details for implementing the PMD Act. They specify:

• Application forms and required documents for manufacturing licences, MAH licences, Shonin applications, and Ninsho applications
• Administrative procedures for licence renewals, change notifications, and withdrawals
• Timing and format requirements for adverse event reports
• Forms for MHLW notifications relating to recalls

Key provisions relevant to medical devices

Subject	Enforcement Regulation reference
Manufacturing licence application requirements	Articles on manufacturing business applications
MAH licence application requirements	Articles on manufacturing sales business applications
Shonin application content	Articles referencing required dossier content
Adverse event report format	Articles on safety reporting forms
Recall notification format	Articles on recall/corrective action reporting

The Enforcement Regulations are updated more frequently than the PMD Act itself, as they deal with procedural details that need to track changing administrative practices.

Official source

e-Gov — PMD Act Enforcement Regulations (search 薬機法施行規則)