Cost Structure of Medical Device Registration in Japan: Four Budget Blocks

1. Key takeaways

The total cost of Japanese registration is made up of four blocks: official fees, Registered Certification Body fees, local licensed-entity services, and Japanese-language document compilation with consultancy. Official fees are statutory or ordinance amounts that can be verified against published sources; the other three blocks are market-priced. GRZAN recommends building the budget line by line across these four blocks, and labelling each item as an official figure or a practical estimate, so that market quotations are never written into external documents as if they were statutory fees.

• Official fees split into two layers: national fees under the PMD Act-related fee order, and prefectural fees under local fee ordinances.
• Published prefectural examples include Type 1 licence application at 149,800 yen, Type 2 at 131,600 yen and Type 3 at 95,200 yen, with renewals at 140,000, 116,800 and 74,700 yen.
• The same examples include manufacturing site registration at 37,800 yen and its renewal at 29,100 yen, conformity investigation fees of 48,800, 28,700 and 13,300 yen by category, and licence certificate reissuance at 2,000 yen and redelivery at 2,900 yen.
• RCB fees are market-priced by each body and vary significantly with product complexity and the need for additional testing.
• Licensed-entity services and vigilance are recurring costs, so a three-year total cost view is more realistic than a first-year registration figure.
• Labelling every budget line as an official figure or a practical estimate keeps market quotations out of external documents.
• The national and local fee layers rest on different instruments and should never be merged into a single estimate.

2. Legal basis

The fee order related to the PMD Act sets the fees for approval reviews, investigations and related procedures. The specific amounts are subject to the current publication of the PMDA and should be taken from that source rather than from secondary summaries.

Prefectural fee ordinances govern the charges collected locally for the manufacturing and marketing business licence, manufacturing site registration, repair business licence, conformity investigation and similar items. Published examples, to be confirmed against the current ordinance of the prefecture of application, include the following: a Type 1 medical device manufacturing and marketing business licence application at 149,800 yen, Type 2 at 131,600 yen, and Type 3 at 95,200 yen; renewals at 140,000, 116,800 and 74,700 yen respectively; a medical device manufacturing site registration application at 37,800 yen with its renewal at 29,100 yen; the medical device conformity investigation application at approval at 48,800 yen for the sterilisation category, 28,700 yen for the general category, and 13,300 yen for the packaging, labelling and storage category; and a licence certificate reissuance application at 2,000 yen with a redelivery application at 2,900 yen.

Article 23-2, paragraph 1, Article 23-2-3, paragraph 1 and Article 23-2-5, paragraph 7 of the PMD Act correspond to the licence, registration and investigation items on which the above fees are charged. Fees for pre-application consultations and similar services of the PMDA follow the current PMDA publication; as a practical estimate, consultation-type meetings of the common kind run in the order of about 39,400 yen per session. The current statutory basis of the regime is Act No. 145 of 1960, as amended.

3. Expert insights

Insight 1: official fees fall into a national layer and a local layer. Fees connected with approval review and investigations are charged under the fee order related to the PMD Act, while licences, registrations and some investigations are charged by the prefectures under their own fee ordinances. The two layers rest on different legal instruments, and their amounts differ as well. Budgeting that merges the layers into a single estimate loses the ability to verify either one, and makes errors hard to spot when ordinances change.

Insight 2: RCB fees are market-priced, and the spread is significant. The fees of Registered Certification Bodies are not set uniformly by law; each body sets its own schedule, and the amounts relate to the complexity of the product and whether supplementary testing is needed. When GRZAN assists clients with comparing quotations, it normally requires each body to issue a written quotation per product, rather than accepting an estimated range by broad category. Category-level ranges hide the variables that actually drive the cost of the specific device.

Insight 3: local holder services and vigilance are long-term costs, not one-off investments. The service fees of the D-MAH or MAH, vigilance and record retention, and the handling of changes and renewals are all recurring expenditure. Measuring total cost of ownership on a three-year horizon comes much closer to reality than counting only the first-year registration fees, and it is the horizon against which structural choices such as self-holding versus MAH-held models should be compared.

4. Practical recommendations

• Structure the budget in the four blocks of official fees, RCB fees, licensed-entity services and document compilation, labelling every line as an official figure or a practical estimate.
• Verify official local fees against the current ordinance of the actual prefecture of application, since prefectures differ.
• Obtain written RCB quotations per product, and decline to accept ranges quoted at broad category level.
• Model licensed-entity services and vigilance costs on a three-year horizon, bringing changes, renewals and periodic investigations into the annual budget.
• Keep the PMDA consultation fee assumptions tied to the current PMDA publication and refresh them as it is revised.
• Review the budget whenever a prefectural ordinance or an RCB schedule changes, rather than only at project start.

5. Verification checklist

• □ Is the budget divided into the four blocks of official fees, RCB fees, licensed-entity services and document compilation?
• □ Is every line labelled as an official figure or a practical estimate?
• □ Have local fees been checked against the current ordinance of the actual prefecture of application?
• □ Have written per-product RCB quotations been obtained?
• □ Have licensed-entity services and vigilance costs been modelled on a three-year horizon?

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