Editorial Policy

Sources

For regulatory requirements, procedures, standards and administrative practice, we prioritize primary sources whenever possible.

Key sources include Japan's Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), laws and official notices, public databases, and official reimbursement materials.

When discussing overseas regulatory systems, we prioritize materials published by the relevant regulatory authorities and public institutions.

Where secondary sources are used, material regulatory points are checked against primary sources whenever practical.

Writing and review

Articles and guides on this website are written and edited by MK Consulting K.K.

Our articles and guides are structured to make regulatory requirements easier to apply in practice, including the relationship among device characteristics, regulatory pathways, clinical use, QMS and reimbursement.

Japan-specific terms and procedures—including Japanese Medical Device Nomenclature (JMDN) codes, approval, certification, notification, PMDA consultation, QMS conformity assessment, clinical evaluation and reimbursement—are described in a way that preserves their meaning under the Japanese regulatory system.

Updates

When laws, official notices, PMDA information or reimbursement rules change, we assess whether existing content is affected and update it when necessary.

Publication and update dates reflect actual publication and substantive content updates. We do not change dates solely to create an appearance of freshness.

Corrections

If we identify an error or unclear statement, we review the relevant source materials and make an appropriate correction.

To report an issue, please contact us through the contact page.

Disclaimer

The information on this website is provided for general information on medical device regulation and market entry.

The procedures, testing, submission documentation and reimbursement treatment required for a specific product depend on factors including intended use, design and operating principle, Japanese generic device name, classification, differences from existing products, and current laws and official notices.

For an actual submission or regulatory decision, confirm the latest official information and, where appropriate, consult PMDA, a Registered Certification Body, the relevant Marketing Authorization Holder (MAH), or other appropriate parties.