PMDA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| PMDA official form sinsa175 | Foreign-manufactured IVD minor-change notification — official blank form Complete 1-page blank official form, including its original table layout and notes, preserved as one exact PDF expression. The captured PMDA form index links this exact URL. No printed issue or commencement date has been established. A blank form does not itself establish the legal classification, current requirements, timing or approval of a particular corporate, product-name or model change. Any other product categories printed in the form remain source context; no drug-specific rule is extended to medical devices or IVD. Present-day legal currentness remains unverified. Complete original page images govern; native extraction is a qualified, potentially incomplete search layer. No whole-country completeness or completed-question claim. | Registration | — | Official |
| PMDA official form sinsa019 | Foreign-manufactured IVD partial-change approval application — official blank form Complete 1-page blank official form, including its original table layout and notes, preserved as one exact PDF expression. The captured PMDA form index links this exact URL. No printed issue or commencement date has been established. A blank form does not itself establish the legal classification, current requirements, timing or approval of a particular corporate, product-name or model change. Any other product categories printed in the form remain source context; no drug-specific rule is extended to medical devices or IVD. Present-day legal currentness remains unverified. Complete original page images govern; native extraction is a qualified, potentially incomplete search layer. No whole-country completeness or completed-question claim. | Registration | — | Official |
| PMDA official form sinsa176 | Foreign-manufactured medical-device and IVD approval succession — official blank form Complete 2-page blank official form, including its original table layout and notes, preserved as one exact PDF expression. The captured PMDA form index links this exact URL. No printed issue or commencement date has been established. A blank form does not itself establish the legal classification, current requirements, timing or approval of a particular corporate, product-name or model change. Any other product categories printed in the form remain source context; no drug-specific rule is extended to medical devices or IVD. Present-day legal currentness remains unverified. Complete original page images govern; native extraction is a qualified, potentially incomplete search layer. No whole-country completeness or completed-question claim. | Registration | — | Official |
| 薬食機参発1121第19号 | IVD certification application instructions — notice of 21 November 2014 Complete 25-page historical official IVD certification notice, including attached standards statements, kit/series instructions and partial-change/minor-change examples. It preserves the original certification-specific product-name, formulation, method and manufacturing-site branches; approval instructions are a different route. It expressly applies from 25 November 2014 and discontinues the cited 2005 notice. Current amendments, submission media, fees and processing periods have not been established by this source-only preservation. Complete original page images govern; native extraction is a qualified, potentially incomplete search layer. No whole-country completeness or completed-question claim. | Registration | — | Official |
| PMDA official form sinsa170 | IVD minor-change notification — official blank form Complete 1-page blank official form, including its original table layout and notes, preserved as one exact PDF expression. The captured PMDA form index links this exact URL. No printed issue or commencement date has been established. A blank form does not itself establish the legal classification, current requirements, timing or approval of a particular corporate, product-name or model change. Any other product categories printed in the form remain source context; no drug-specific rule is extended to medical devices or IVD. Present-day legal currentness remains unverified. Complete original page images govern; native extraction is a qualified, potentially incomplete search layer. No whole-country completeness or completed-question claim. | Registration | — | Official |
| PMDA official form sinsa014 | IVD partial-change approval application — official blank form Complete 1-page blank official form, including its original table layout and notes, preserved as one exact PDF expression. The captured PMDA form index links this exact URL. No printed issue or commencement date has been established. A blank form does not itself establish the legal classification, current requirements, timing or approval of a particular corporate, product-name or model change. Any other product categories printed in the form remain source context; no drug-specific rule is extended to medical devices or IVD. Present-day legal currentness remains unverified. Complete original page images govern; native extraction is a qualified, potentially incomplete search layer. No whole-country completeness or completed-question claim. | Registration | — | Official |
| 医薬機審発1225第1号・医薬監麻発1225第1号 | IVD product transition after partial-change approval or certification — joint notice of 25 December 2025 Complete 3-page joint notice, including its context for regenerative products, retained as one exact original. The IVD branch permits older-product shipment only for its stated technical fields and inventory/record conditions, and explicitly excludes Name, Intended Use and Method of Use. It applies to partial-change applications submitted on or after issue and rescinds the cited 2018 notice. It does not establish general sell-through of old-name labels or a general medical-device rule. Date is the printed notice date; present-day legal currentness remains unverified. Source images govern; native text is a qualified search layer. No whole-country completeness claim. | Registration | — | Official |
| 事務連絡（令和7年12月25日・製品切替えQ&A） | IVD product transition after partial-change approval or certification — Q&A of 25 December 2025 Complete 5-page official administrative communication and attached five-question Q&A, including regenerative-product examples retained in original context. It addresses IFU revisions, successive changes before stock exhaustion, partial implementation, master-file changes and application wording/removal. It rescinds the cited 2018 Q&A. Application to IVD remains subject to the companion notice’s limited field scope; no general old-name-label sell-through or medical-device rule is inferred. Date is the printed communication date; present-day legal currentness remains unverified. Source images govern; native text is a qualified search layer. No whole-country completeness claim. | Registration | — | Official |
| PMDA official form sinsa165 | Marketing notification change — official Form 40 Complete 1-page blank official form, including its original table layout and notes, preserved as one exact PDF expression. The captured PMDA form index links this exact URL. No printed issue or commencement date has been established. A blank form does not itself establish the legal classification, current requirements, timing or approval of a particular corporate, product-name or model change. Any other product categories printed in the form remain source context; no drug-specific rule is extended to medical devices or IVD. Present-day legal currentness remains unverified. Complete original page images govern; native extraction is a qualified, potentially incomplete search layer. No whole-country completeness or completed-question claim. | Registration | — | Official |
| PMDA official form sinsa171 | Medical-device and IVD approval succession — official blank form Complete 1-page blank official form, including its original table layout and notes, preserved as one exact PDF expression. The captured PMDA form index links this exact URL. No printed issue or commencement date has been established. A blank form does not itself establish the legal classification, current requirements, timing or approval of a particular corporate, product-name or model change. Any other product categories printed in the form remain source context; no drug-specific rule is extended to medical devices or IVD. Present-day legal currentness remains unverified. Complete original page images govern; native extraction is a qualified, potentially incomplete search layer. No whole-country completeness or completed-question claim. | Registration | — | Official |
| 薬食機参発0925第1号 (25 September 2014) | Succession procedures for medical-device and IVD certification Complete four-page MHLW notice for succession of MD/IVD certification. This certification-specific procedure is not a universal transfer of every approval, MAH licence or manufacturing site. Held bytes are preserved in full; this is not a current-law or whole-country completeness certification. | Registration | — | Official |
| 薬食機参発1119第7号・薬食監麻発1119第12号 | Medical-device and IVD manufacturing-site changes — joint notice of 19 November 2014 Complete nine-page official joint notice, including the annexed submission list and declaration form. It distinguishes specified manufacturing-site changes from manufacturer name/address notation changes and corporate changes subject to its express legal-personality and unchanged-QMS conditions. It expressly applies from 25 November 2014 and discontinues the cited 2007 notice; no present-day consolidation or current fee/processing-time conclusion is made. The actual PDF contains historical procedures and cross-references, preserved in full. Complete original page images govern; native extraction is a qualified, potentially incomplete search layer. No whole-country completeness or completed-question claim. | Registration | — | Official |
| MHLW FY2025 national pharmaceutical-affairs meeting — reference materials | 令和7年度全国薬務関係主管課長会議（参考資料）— complete 77-page Medical Device Evaluation Division reference Complete 77-page official FY2025 national pharmaceutical-affairs meeting reference PDF issued by the MHLW Medical Device Evaluation Division. Cover and contents are preserved at physical pages 1–2; the 2024 medical-device collaborative review plan is physical pages 3–5 and the separate 2024 IVD plan is pages 6–7. The MD plan section 8 at pages 4–5 states cohort 80th-percentile review targets, including four months for the specified partial-change approval branch; it is not a statutory deadline or a complete elapsed time for every change, transfer or IVD scenario. The IVD plan has its own target branches and is not assigned the MD four-month target. All remaining source reference sections are retained, including regenerative-medicine context, device statistics, certification bodies, cybersecurity and international-regulatory cooperation; their presence does not make each section a device-change obligation. Many pages are scanned or have native text limited to page numbers: all 77 original page images govern, and the unchanged native layer is expressly incomplete for searching rather than silently corrected, OCR-reconstructed or called blank. The document cover gives FY2025, not an exact publication/effective date; no such date or current-law status is inferred. Reuses the exact historical official GET of 20 October 2026 without a fresh retrieval claim. | Registration | — | Official |
| 医薬機審発0507第1号 (7 May 2026) | IVD approval application instructions — 7 May 2026 corrected expression Complete38-page MHLW corrected expression, with correction notice, comparison material and reference instructions. Ordinary-device and IVD change categories remain distinct; prior and revised columns are not interchangeable. Held bytes are preserved in full; this is not a current-law or whole-country completeness certification. The two-column/four-column comparative material is a source comparison, not a licence to combine prior and revised provisions. | Registration | — | Official |
| 厚生省令第一号（昭和三十六年二月一日） | 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律施行規則 — complete official consolidated body and image attachments Complete historical MHLW consolidated Enforcement Rule body held20October2026, including all26 native tables, ruby readings, original source IDs, amendments and supplementary provisions. All418 source-linked original form/annex PNG occurrences are separately preserved from normal official GET captures27October2026 (415 unique images), together with the original external-window UI icon. The instrument spans pharmaceuticals, medical devices, IVDs and regenerative products; MD/IVD scope is limited to the applicable provisions. Image-only attachments remain image originals and are not claimed as fully transcribed searchable text. Capture dates do not establish current legal effect, a universal filing deadline or review duration; no whole-source question mapping is inferred. | General | — | Official |
| PMDA foreign-manufacturer registration procedures | 医療機器等外国製造業者の登録申請について（医療機器、体外診断用医薬品） Complete captured PMDA service guidance for foreign manufacturers of medical devices and IVD, including initial registration, renewal, name/address changes, closure, certificate rewriting/reissue, supporting documents and references. Actual manufacturing-site relocation and address-notation changes remain distinct in the original. Retains all source wording and original links, including conditional and historical statements; no fee, timing, present-day legal-currentness or answered-question determination is inferred. | Registration | — | Official |
| PMDA MD/IVD fee table — revision 20 May 2022 | Medical-device and IVD review fees — complete PMDA table revised 20 May 2022 Complete eight-page Japanese PMDA fee-table expression with its printed revision of 20 May 2022, review/conformity columns, article references and footnotes. This is a historical table expression; it does not establish current fees or a universal fee for every corporate, product-name or model change. The unchanged native extraction preserves a qualified search layer, while full original page images preserve the table layout. No fee data, currentness assertion or completed-question determination is added. | Registration | — | Official |
Exports carry source + retrieval dateSource-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
Verified guidance on
Read each rule with its scope and conditions.
A change to matters actually reported for a notified MD or IVD has a30-day post-change notice under Act23-2-12. Certification-route changes go to the registered certification body through the corresponding partial/minor provisions, including Forms65/66 under Rule118. These distinct procedures do not turn a certification change into a PMDA partial approval or treat every actor-detail edit as a product-field change.
The corrected 7 May2026 IVD instructions classify a sales-name change accompanying a business/trade-name or trademark change as a minor notification. Other sales-name changes require partial-change approval; unifying sales names for corporate identity is explicitly a partial-change example. Changes outside approval matters or extremely minor changes not affecting performance may need neither procedure under section4(4).
Rule 114-24 prescribes Form 63-9 for a partial-change approval application for an approved MD or IVD. Additional statutory evidence applies in the specific Article23-2-8 case. The actual substantive supporting studies depend on what approved matter changes; this form provision is not a universal complete technical checklist.
An orderable REF is not itself a Japanese statutory change category. Compare it with the approved, certified or notified sales name, specifications, model/configuration and actual label. Rule 114-25 separately identifies MD and IVD changes excluded from the minor route; the current MD Annex2 and IVD section4 then distinguish partial approval, minor notice and new approval. A replacement code with no mapped field or technical change cannot be assigned a universal filing or UDI consequence from these provisions.
Approved IVD minor changes are notified within 30 days after the change using the applicable minor-change form. The corrected IVD instructions require a copy of the approval; partial-change applications include an approval copy, specific old/new comparison and reasons, and approval history. A notification deadline is not an authority review duration.
The currently linked Japanese fee table lists JPY 150600 for other-IVD partial approval and JPY 33400 for the IVD series-addition partial category. It also lists separate clinical/technical categories and QMS charges. These are route-specific rows, not a universal IVD brand, succession or bundled-change fee.
PMD Act50 requires the MAH name/address, product name, manufacturing number/code and applicable other particulars on the immediate container or wrapper, subject to Ordinance exceptions; it expressly refers to prescribed IVD standards. Use this IVD/drug-label provision rather than inheriting the MD-only Article63 label rule.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
Verified guidance on
Read each rule with its scope and conditions.
A change to matters actually reported for a notified MD or IVD has a30-day post-change notice under Act23-2-12. Certification-route changes go to the registered certification body through the corresponding partial/minor provisions, including Forms65/66 under Rule118. These distinct procedures do not turn a certification change into a PMDA partial approval or treat every actor-detail edit as a product-field change.
For MDs and IVDs, changes to the same MAH name/address or main office and changes to manufacturer/foreign-manufacturer name/address or site name have actor-record notifications separate from product changes. The relevant Rule 114-69/70 procedure uses Form 6 and corporate registration evidence for a corporate name change; Act23-2-16 gives30 days. An office address is not automatically a relocated factory or a transferred product approval.
The corrected 7 May2026 IVD instructions classify a sales-name change accompanying a business/trade-name or trademark change as a minor notification. Other sales-name changes require partial-change approval; unifying sales names for corporate identity is explicitly a partial-change example. Changes outside approval matters or extremely minor changes not affecting performance may need neither procedure under section4(4).
Rule 114-24 prescribes Form 63-9 for a partial-change approval application for an approved MD or IVD. Additional statutory evidence applies in the specific Article23-2-8 case. The actual substantive supporting studies depend on what approved matter changes; this form provision is not a universal complete technical checklist.
An orderable REF is not itself a Japanese statutory change category. Compare it with the approved, certified or notified sales name, specifications, model/configuration and actual label. Rule 114-25 separately identifies MD and IVD changes excluded from the minor route; the current MD Annex2 and IVD section4 then distinguish partial approval, minor notice and new approval. A replacement code with no mapped field or technical change cannot be assigned a universal filing or UDI consequence from these provisions.
The certification-succession notice permits new and old sales names in the succession form only for replacing or removing the corporate-name element of a sales name in the stated circumstances. Certification matters otherwise pass unchanged; changing the actual manufacturer requires its own change procedure. This is a specific combined-name permission, not approval to bundle every brand, address, REF or technical change with succession.
Approved IVD minor changes are notified within 30 days after the change using the applicable minor-change form. The corrected IVD instructions require a copy of the approval; partial-change applications include an approval copy, specific old/new comparison and reasons, and approval history. A notification deadline is not an authority review duration.
The currently linked Japanese fee table lists JPY 150600 for other-IVD partial approval and JPY 33400 for the IVD series-addition partial category. It also lists separate clinical/technical categories and QMS charges. These are route-specific rows, not a universal IVD brand, succession or bundled-change fee.
PMD Act50 requires the MAH name/address, product name, manufacturing number/code and applicable other particulars on the immediate container or wrapper, subject to Ordinance exceptions; it expressly refers to prescribed IVD standards. Use this IVD/drug-label provision rather than inheriting the MD-only Article63 label rule.
Corrected IVD section4(5) allows a minor notification while a partial-change approval application is pending. If the minor change concerns the same field as the pending partial application, replace that application to include all of the minor-change matters. This precise coexistence rule does not by itself create a single fee or authorise all seven transfer combinations in one filing.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
Verified guidance on
Read each rule with its scope and conditions.
A change to matters actually reported for a notified MD or IVD has a30-day post-change notice under Act23-2-12. Certification-route changes go to the registered certification body through the corresponding partial/minor provisions, including Forms65/66 under Rule118. These distinct procedures do not turn a certification change into a PMDA partial approval or treat every actor-detail edit as a product-field change.
For MDs and IVDs, changes to the same MAH name/address or main office and changes to manufacturer/foreign-manufacturer name/address or site name have actor-record notifications separate from product changes. The relevant Rule 114-69/70 procedure uses Form 6 and corporate registration evidence for a corporate name change; Act23-2-16 gives30 days. An office address is not automatically a relocated factory or a transferred product approval.
The corrected 7 May2026 IVD instructions classify a sales-name change accompanying a business/trade-name or trademark change as a minor notification. Other sales-name changes require partial-change approval; unifying sales names for corporate identity is explicitly a partial-change example. Changes outside approval matters or extremely minor changes not affecting performance may need neither procedure under section4(4).
Rule 114-24 prescribes Form 63-9 for a partial-change approval application for an approved MD or IVD. Additional statutory evidence applies in the specific Article23-2-8 case. The actual substantive supporting studies depend on what approved matter changes; this form provision is not a universal complete technical checklist.
An orderable REF is not itself a Japanese statutory change category. Compare it with the approved, certified or notified sales name, specifications, model/configuration and actual label. Rule 114-25 separately identifies MD and IVD changes excluded from the minor route; the current MD Annex2 and IVD section4 then distinguish partial approval, minor notice and new approval. A replacement code with no mapped field or technical change cannot be assigned a universal filing or UDI consequence from these provisions.
The certification-succession notice permits new and old sales names in the succession form only for replacing or removing the corporate-name element of a sales name in the stated circumstances. Certification matters otherwise pass unchanged; changing the actual manufacturer requires its own change procedure. This is a specific combined-name permission, not approval to bundle every brand, address, REF or technical change with succession.
Approved IVD minor changes are notified within 30 days after the change using the applicable minor-change form. The corrected IVD instructions require a copy of the approval; partial-change applications include an approval copy, specific old/new comparison and reasons, and approval history. A notification deadline is not an authority review duration.
The currently linked Japanese fee table lists JPY 150600 for other-IVD partial approval and JPY 33400 for the IVD series-addition partial category. It also lists separate clinical/technical categories and QMS charges. These are route-specific rows, not a universal IVD brand, succession or bundled-change fee.
PMD Act50 requires the MAH name/address, product name, manufacturing number/code and applicable other particulars on the immediate container or wrapper, subject to Ordinance exceptions; it expressly refers to prescribed IVD standards. Use this IVD/drug-label provision rather than inheriting the MD-only Article63 label rule.
Corrected IVD section4(5) allows a minor notification while a partial-change approval application is pending. If the minor change concerns the same field as the pending partial application, replace that application to include all of the minor-change matters. This precise coexistence rule does not by itself create a single fee or authorise all seven transfer combinations in one filing.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
Verified guidance on
Read each rule with its scope and conditions.
A change to matters actually reported for a notified MD or IVD has a30-day post-change notice under Act23-2-12. Certification-route changes go to the registered certification body through the corresponding partial/minor provisions, including Forms65/66 under Rule118. These distinct procedures do not turn a certification change into a PMDA partial approval or treat every actor-detail edit as a product-field change.
An orderable REF is not itself a Japanese statutory change category. Compare it with the approved, certified or notified sales name, specifications, model/configuration and actual label. Rule 114-25 separately identifies MD and IVD changes excluded from the minor route; the current MD Annex2 and IVD section4 then distinguish partial approval, minor notice and new approval. A replacement code with no mapped field or technical change cannot be assigned a universal filing or UDI consequence from these provisions.
The corrected 7 May2026 IVD instructions classify a sales-name change accompanying a business/trade-name or trademark change as a minor notification. Other sales-name changes require partial-change approval; unifying sales names for corporate identity is explicitly a partial-change example. Changes outside approval matters or extremely minor changes not affecting performance may need neither procedure under section4(4).
Rule 114-24 prescribes Form 63-9 for a partial-change approval application for an approved MD or IVD. Additional statutory evidence applies in the specific Article23-2-8 case. The actual substantive supporting studies depend on what approved matter changes; this form provision is not a universal complete technical checklist.
The certification-succession notice permits new and old sales names in the succession form only for replacing or removing the corporate-name element of a sales name in the stated circumstances. Certification matters otherwise pass unchanged; changing the actual manufacturer requires its own change procedure. This is a specific combined-name permission, not approval to bundle every brand, address, REF or technical change with succession.
Approved IVD minor changes are notified within 30 days after the change using the applicable minor-change form. The corrected IVD instructions require a copy of the approval; partial-change applications include an approval copy, specific old/new comparison and reasons, and approval history. A notification deadline is not an authority review duration.
The currently linked Japanese fee table lists JPY 150600 for other-IVD partial approval and JPY 33400 for the IVD series-addition partial category. It also lists separate clinical/technical categories and QMS charges. These are route-specific rows, not a universal IVD brand, succession or bundled-change fee.
PMD Act50 requires the MAH name/address, product name, manufacturing number/code and applicable other particulars on the immediate container or wrapper, subject to Ordinance exceptions; it expressly refers to prescribed IVD standards. Use this IVD/drug-label provision rather than inheriting the MD-only Article63 label rule.
Corrected IVD section4(5) allows a minor notification while a partial-change approval application is pending. If the minor change concerns the same field as the pending partial application, replace that application to include all of the minor-change matters. This precise coexistence rule does not by itself create a single fee or authorise all seven transfer combinations in one filing.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
Verified guidance on
Read each rule with its scope and conditions.
A change to matters actually reported for a notified MD or IVD has a30-day post-change notice under Act23-2-12. Certification-route changes go to the registered certification body through the corresponding partial/minor provisions, including Forms65/66 under Rule118. These distinct procedures do not turn a certification change into a PMDA partial approval or treat every actor-detail edit as a product-field change.
PMD Act23-2-11 expressly provides succession to MD/IVD approval-holder status on inheritance, merger, qualifying division, or transfer of the prescribed product data with the purpose of succeeding to that status. Notify before succession except inheritance, which is notified promptly afterward. Rule 114-46 requires Form 63-20, proof of successor status and transfer of the specified registration/approval, quality and post-market information.
The MD/IVD certification-succession notice requires Form 68-5 to the existing certification body, with succession-contract/inheritance evidence, the predecessor undertaking to transfer the specified data and certification copies. For non-inheritance events the indicative filing point is one month before succession; inheritance is notified promptly after. Where actual manufacturing is unchanged, holder succession is distinct from changing manufacturing to another manufacturer.
The corrected 7 May2026 IVD instructions classify a sales-name change accompanying a business/trade-name or trademark change as a minor notification. Other sales-name changes require partial-change approval; unifying sales names for corporate identity is explicitly a partial-change example. Changes outside approval matters or extremely minor changes not affecting performance may need neither procedure under section4(4).
Rule 114-24 prescribes Form 63-9 for a partial-change approval application for an approved MD or IVD. Additional statutory evidence applies in the specific Article23-2-8 case. The actual substantive supporting studies depend on what approved matter changes; this form provision is not a universal complete technical checklist.
An orderable REF is not itself a Japanese statutory change category. Compare it with the approved, certified or notified sales name, specifications, model/configuration and actual label. Rule 114-25 separately identifies MD and IVD changes excluded from the minor route; the current MD Annex2 and IVD section4 then distinguish partial approval, minor notice and new approval. A replacement code with no mapped field or technical change cannot be assigned a universal filing or UDI consequence from these provisions.
The certification-succession notice permits new and old sales names in the succession form only for replacing or removing the corporate-name element of a sales name in the stated circumstances. Certification matters otherwise pass unchanged; changing the actual manufacturer requires its own change procedure. This is a specific combined-name permission, not approval to bundle every brand, address, REF or technical change with succession.
Approved IVD minor changes are notified within 30 days after the change using the applicable minor-change form. The corrected IVD instructions require a copy of the approval; partial-change applications include an approval copy, specific old/new comparison and reasons, and approval history. A notification deadline is not an authority review duration.
The currently linked Japanese fee table lists JPY 150600 for other-IVD partial approval and JPY 33400 for the IVD series-addition partial category. It also lists separate clinical/technical categories and QMS charges. These are route-specific rows, not a universal IVD brand, succession or bundled-change fee.
PMD Act50 requires the MAH name/address, product name, manufacturing number/code and applicable other particulars on the immediate container or wrapper, subject to Ordinance exceptions; it expressly refers to prescribed IVD standards. Use this IVD/drug-label provision rather than inheriting the MD-only Article63 label rule.
Corrected IVD section4(5) allows a minor notification while a partial-change approval application is pending. If the minor change concerns the same field as the pending partial application, replace that application to include all of the minor-change matters. This precise coexistence rule does not by itself create a single fee or authorise all seven transfer combinations in one filing.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
Verified guidance on
Read each rule with its scope and conditions.
A change to matters actually reported for a notified MD or IVD has a30-day post-change notice under Act23-2-12. Certification-route changes go to the registered certification body through the corresponding partial/minor provisions, including Forms65/66 under Rule118. These distinct procedures do not turn a certification change into a PMDA partial approval or treat every actor-detail edit as a product-field change.
For MDs and IVDs, changes to the same MAH name/address or main office and changes to manufacturer/foreign-manufacturer name/address or site name have actor-record notifications separate from product changes. The relevant Rule 114-69/70 procedure uses Form 6 and corporate registration evidence for a corporate name change; Act23-2-16 gives30 days. An office address is not automatically a relocated factory or a transferred product approval.
An orderable REF is not itself a Japanese statutory change category. Compare it with the approved, certified or notified sales name, specifications, model/configuration and actual label. Rule 114-25 separately identifies MD and IVD changes excluded from the minor route; the current MD Annex2 and IVD section4 then distinguish partial approval, minor notice and new approval. A replacement code with no mapped field or technical change cannot be assigned a universal filing or UDI consequence from these provisions.
PMD Act23-2-11 expressly provides succession to MD/IVD approval-holder status on inheritance, merger, qualifying division, or transfer of the prescribed product data with the purpose of succeeding to that status. Notify before succession except inheritance, which is notified promptly afterward. Rule 114-46 requires Form 63-20, proof of successor status and transfer of the specified registration/approval, quality and post-market information.
The MD/IVD certification-succession notice requires Form 68-5 to the existing certification body, with succession-contract/inheritance evidence, the predecessor undertaking to transfer the specified data and certification copies. For non-inheritance events the indicative filing point is one month before succession; inheritance is notified promptly after. Where actual manufacturing is unchanged, holder succession is distinct from changing manufacturing to another manufacturer.
The corrected 7 May2026 IVD instructions classify a sales-name change accompanying a business/trade-name or trademark change as a minor notification. Other sales-name changes require partial-change approval; unifying sales names for corporate identity is explicitly a partial-change example. Changes outside approval matters or extremely minor changes not affecting performance may need neither procedure under section4(4).
Rule 114-24 prescribes Form 63-9 for a partial-change approval application for an approved MD or IVD. Additional statutory evidence applies in the specific Article23-2-8 case. The actual substantive supporting studies depend on what approved matter changes; this form provision is not a universal complete technical checklist.
The certification-succession notice permits new and old sales names in the succession form only for replacing or removing the corporate-name element of a sales name in the stated circumstances. Certification matters otherwise pass unchanged; changing the actual manufacturer requires its own change procedure. This is a specific combined-name permission, not approval to bundle every brand, address, REF or technical change with succession.
Approved IVD minor changes are notified within 30 days after the change using the applicable minor-change form. The corrected IVD instructions require a copy of the approval; partial-change applications include an approval copy, specific old/new comparison and reasons, and approval history. A notification deadline is not an authority review duration.
The currently linked Japanese fee table lists JPY 150600 for other-IVD partial approval and JPY 33400 for the IVD series-addition partial category. It also lists separate clinical/technical categories and QMS charges. These are route-specific rows, not a universal IVD brand, succession or bundled-change fee.
PMD Act50 requires the MAH name/address, product name, manufacturing number/code and applicable other particulars on the immediate container or wrapper, subject to Ordinance exceptions; it expressly refers to prescribed IVD standards. Use this IVD/drug-label provision rather than inheriting the MD-only Article63 label rule.
Corrected IVD section4(5) allows a minor notification while a partial-change approval application is pending. If the minor change concerns the same field as the pending partial application, replace that application to include all of the minor-change matters. This precise coexistence rule does not by itself create a single fee or authorise all seven transfer combinations in one filing.
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
Keep Japan as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Check a preliminary PMDA risk class.
Inspect public PMDA records.
Search the same product in multiple country registries.
Estimate pathway, government fees, preparation, and review time.
Structure company, product, model, approval, and evidence facts once.
Compare existing evidence against Japan needs.
Connect route, evidence, labels, representatives, and launch dependencies.
Test a current PMDA update against one product and its evidence.
