Regulatory Status

Regulatory Pathway & Quality System

Airato is pursuing PMDA registration for its IMRT planning software as a Software as a Medical Device (SaMD) under the Japan Pharmaceutical and Medical Devices Act. This page provides transparent status documentation for hospital procurement teams and clinical compliance officers. PMDA registration has not yet been granted.

Pathway Active

Japan PMDA Registration

Airato is pursuing PMDA registration as a Software as a Medical Device (SaMD) for radiation therapy treatment planning assistance. Pre-consultation submitted. Registration not yet granted.

Japan PMDA detail

Active

Quality Management System

Quality management system designed with ISO 13485 principles as the framework. Documentation, change control, and complaint handling procedures established for software development lifecycle.

In Design

IEC 62304 Software Lifecycle

Software development process designed to align with IEC 62304 medical device software lifecycle requirements. Formal certification in scope for PMDA submission package.

Software Development Lifecycle

Development process designed with IEC 62304 Class B software lifecycle controls: change control, traceability, verification and validation documentation.

Risk Management

Risk management framework aligned with ISO 14971 principles. Risk analysis documented for AI algorithm outputs and clinical decision support use cases.

Post-Market Surveillance

Complaint handling and adverse event reporting procedures established per ISO 13485 requirements. Clinical site feedback systematically collected and reviewed for safety-relevant signals; findings routed to risk management documentation.

Intended Use (Draft — subject to PMDA review): Airato is a software system intended to assist qualified medical physicists in generating initial beam configuration candidates and optimizing dose distribution for Intensity Modulated Radiation Therapy (IMRT) treatment planning. The system is intended for use as a planning assistance tool only — it does not make autonomous treatment decisions. All AI-generated outputs require review, modification where necessary, and explicit approval by a qualified medical physicist before any treatment plan is used clinically. The system is not intended for patient diagnosis or for direct patient treatment delivery control.

This intended use statement is draft and subject to revision during the PMDA registration process. The final approved intended use statement will supersede this draft on registration.

Regulatory questions for procurement?

Our regulatory team can provide documentation packages for hospital procurement review processes.

Contact Regulatory Team