Recent Amendments and Effective Dates

PMD Act amendments tracker

Amendment	Key changes	Effective date
2014 amendments	Renamed PAL to PMD Act; three-pathway system formalised; Programme Medical Devices introduced; regenerative medicine product category created	November 2014 (phased)
2019 amendments	SAKIGAKE designation given statutory basis; conditional/time-limited approval expanded to devices; Programme Medical Device framework clarified	December 2019 (phased)
2023 amendments	Digital regulatory infrastructure; enhanced enforcement; advertising provision updates	2023–2024 (phased)

Ministerial Ordinance amendments tracker

Ordinance	Key change	Effective date
MO 169 (QMS Ordinance)	Major revision to align with ISO 13485:2016	April 2021
GCP Ordinance for Devices	Updates to ethics committee requirements	Multiple amendments
Labelling Ordinance	UDI implementation phased requirements	2021 onwards (phased by device class)

MHLW notification updates — recent key publications

MHLW issues new and updated notifications regularly. Recent areas of activity include:

• AI/ML medical devices — classification and post-market change management guidance (2021 onwards)
• Cybersecurity — guidance for networked and software-enabled devices (PMDA notices, 2021 onwards)
• UDI implementation — phased implementation schedule by device class
• eIFU — ongoing policy development (no general permission issued as of knowledge date)
• IMDRF guidance adoption — Japan continues to adopt and adapt IMDRF guidance documents on an ongoing basis

Upcoming changes

Japan's regulatory environment is continuously evolving. Key areas to monitor:

• Finalisation of UDI implementation requirements for all device classes
• Potential eIFU policy formalisation
• IMDRF guidance adoption (Japan participates actively in IMDRF)
• Digital health and AI/ML device regulation refinement

Official source

Monitor MHLW pharmaceutical/device policy page and PMDA What's New for the latest notifications and guidance.