Japan Regulatory

Japan PMDA Pathway for Airato

Airato is pursuing PMDA registration for its IMRT treatment planning software as a Software as a Medical Device under the PMD Act. This page describes the regulatory pathway being followed and does not constitute a claim of current PMDA approval.

Regulatory Transparency Notice: Airato is pursuing PMDA registration for its radiation therapy planning software. This page describes the regulatory pathway and current status. It does not constitute a claim of current PMDA approval or marketing authorization. All clinical use of Airato is conducted under institutional review and with full understanding that PMDA registration has not yet been granted.
PMDA Pathway

Japan SaMD Regulatory Pathway

Software as a Medical Device (SaMD) in Japan is regulated under the Pharmaceutical and Medical Devices Act (PMD Act) with PMDA as the review authority.

Device Classification

Airato is evaluating classification under Class II (controlled medical device) as a treatment planning assistance software. Final classification determined by PMDA in consultation process.

Pre-Consultation

PMDA pre-consultation (jizen-soudan) submitted for classification confirmation and intended use review. Consultation process ongoing.

Submission Package

Regulatory submission package in preparation: software documentation per IEC 62304, clinical performance data, risk management file per ISO 14971.

Registration Timeline

Pathway Milestones

Planned milestones. Actual dates subject to PMDA review timelines and consultation outcomes.

✓

Quality System Establishment

ISO 13485-aligned QMS design complete. IEC 62304 software lifecycle documentation established. Completed 2024.

✓

PMDA Pre-Consultation (jizen-soudan)

Pre-consultation for device classification and intended use review. Submitted early 2025, response anticipated mid-2025.

3

Clinical Data Package Completion

Dosimetric performance validation study completion and Japanese-language clinical evaluation report.

4

Formal PMDA Submission

Full regulatory submission to PMDA. Review period typically 12–18 months for Class II SaMD.

5

PMDA Registration

Marketing authorization (ninsho) granted. Commercial deployment under approved intended use. Target 2027.

Regulatory documentation for procurement.

Hospital procurement teams can request a regulatory status summary document for internal review.

Request Regulatory Documentation