Import, Distribution Licensing and NHI Reimbursement for Devices in Japan

1. Key takeaways

In Japan, obtaining an approval or certification answers only the question of whether the product may be sold; it does not answer whether hospitals will buy it. The distribution stage carries its own sales and rental business licence or notification requirements, and access to mainstream hospital procurement additionally involves National Health Insurance listing, which belongs to a separate legal domain. GRZAN recommends splitting a Japan project into three parallel lines: regulatory compliance, distribution qualifications, and insurance and market access.

• Sales and rental of highly controlled medical devices require a licence from the prefectural governor under Article 39, paragraph 1 of the PMD Act.
• Sales and rental of controlled medical devices require only a notification to the prefectural governor under Article 39-3, paragraph 1.
• The medical device repair business licence, under Article 40-2, paragraph 1, is issued by the local welfare bureau director or the prefectural governor.
• Approval, under Article 23-2-5, paragraph 1, governs whether manufacturing and marketing is permitted and sits in a different provision from the distribution-stage licences.
• Insurance listing belongs to the health insurance law framework and the deliberations of the Central Social Insurance Medical Council, and its provisions and cycles should be confirmed against current MHLW and Council materials, as a practical estimate.
• The three lines, regulatory compliance, distribution qualifications and insurance access, have different timelines and should be tracked separately.
• Partner qualification must be checked against the product classification, since licence-based and notification-based businesses cover different device tiers.
• Devices needing on-site servicing raise the separate question of the repair business licence.

2. Legal basis

Article 39, paragraph 1 of the PMD Act requires a licence from the prefectural governor to operate the sales or rental business for highly controlled medical devices. Article 39-3, paragraph 1 requires notification to the prefectural governor for the sales or rental business of controlled medical devices. Article 40-2, paragraph 1 provides the medical device repair business licence, granted by the local welfare bureau director or the prefectural governor.

Article 160, paragraph 1 and Article 163 of the Implementing Rules set out the application forms and required particulars for the licences and notifications above. Article 23-2-5, paragraph 1 of the PMD Act governs approval, which resolves whether manufacturing and marketing is permitted; it belongs to a different provision from the sales-stage licensing regime.

Insurance listing falls within the framework of the health insurance law, in particular the medical fee rules and the deliberations of the Central Social Insurance Medical Council. The specific provisions and cycles should be confirmed against current materials of the Ministry of Health, Labour and Welfare and the Council; this is stated as a practical estimate pending verification. The current statutory basis of the regime is Act No. 145 of 1960, as amended.

3. Expert insights

Insight 1: manufacturing and marketing, sales and rental, and repair are three different regulated businesses. The manufacturing and marketing business licence under Article 23-2, paragraph 1, the sales and rental business licence or notification under Article 39, paragraph 1 and Article 39-3, paragraph 1, and the repair business licence under Article 40-2, paragraph 1 each address a different stage. Holding the manufacturing and marketing business licence does not automatically confer qualification at the distribution stage. A project plan that assumes the licensed entity can also distribute, or that the distributor needs nothing beyond a trading licence, misreads the structure of the regime.

Insight 2: distribution requirements are tiered by device classification. Highly controlled medical devices require a licence, while controlled medical devices require only a notification. This tiering tracks product risk, and it has direct commercial consequences: when selecting distribution partners, the partner’s qualification must be checked to confirm that it covers the classification of the target product. A partner qualified only for notified devices cannot lawfully handle a highly controlled product, however strong its channel otherwise is.

Insight 3: insurance listing and regulatory approval are two separate procedures. The PMD Act governs whether manufacturing and marketing is permitted; insurance listing determines whether medical institutions can use the product with insurance reimbursement. The two are handled in different legal domains under different procedures, and their pacing differs as well. GRZAN normally manages insurance listing as a market access work package independent of registration, with the listing cycle and specific classification to be confirmed against current MHLW materials, as a practical estimate pending verification.

4. Practical recommendations

• Plan the project along three lines, with separate milestones for regulatory compliance, distribution qualifications, and insurance and market access.
• Check the qualifications of distribution partners against the specific product, confirming that their sales or rental business licence or notification covers the target classification.
• Assess the repair business licence separately for devices requiring on-site servicing, especially large equipment and devices under specified maintenance control.
• Bring the insurance listing evaluation forward to the registration stage, so that product positioning and pricing strategy are considered already during document preparation.
• Keep the three lines on separate trackers, since their timelines and responsible parties rarely coincide.
• Confirm the application forms and particulars for each distribution licence or notification against the Implementing Rules.
• Document the split between regulatory approval and insurance listing in the project charter, so that neither line is assumed to deliver the other.
• Re-confirm insurance listing provisions and cycles against current MHLW and Council materials at each planning round.

5. Verification checklist

• □ Has it been confirmed that distribution partners hold the Article 39, paragraph 1 licence or have completed the Article 39-3, paragraph 1 notification?
• □ Do those qualifications cover the classification of the target product, highly controlled or controlled?
• □ Has the Article 40-2, paragraph 1 repair business licence been assessed for devices requiring on-site servicing?
• □ Is insurance listing managed as a work package independent of regulatory registration?
• □ Has the assumption that obtaining approval equals access to hospital sales been avoided?

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, in-country representative and local testing support for the Japanese market. Our team coordinates In-Country Representative arrangements, marketing authorisation holder duties, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com