Japan medical device regulations

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.

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 currently linked Japanese fee table lists JPY 182200 for review in the other-medical-device partial-approval category. Its listed conformity-assessment component is JPY 48400 where applicable(totalJPY230600), with JPY 182200 shown where conformity assessment is not required. Adding a sales name has a distinct JPY 37300 review row. These amounts are conditional on that exact application category; other technical review, QMS, travel or certification-body charges may be separate.

Minor (軽微な) changes to approved items are notified to MHLW within 30 days after making the change.

The 2024 medical-device collaborative plan sets a four-month total review target for follow-on-device partial-approval applications, measured at the 80th percentile of the application cohort. It is a target for that review category, not a guaranteed duration for all brand, office, succession or combined changes. A30-day minor-notice deadline is a different measure.

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.

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.

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 currently linked Japanese fee table lists JPY 182200 for review in the other-medical-device partial-approval category. Its listed conformity-assessment component is JPY 48400 where applicable(totalJPY230600), with JPY 182200 shown where conformity assessment is not required. Adding a sales name has a distinct JPY 37300 review row. These amounts are conditional on that exact application category; other technical review, QMS, travel or certification-body charges may be separate.

Minor (軽微な) changes to approved items are notified to MHLW within 30 days after making the change.

The 2024 medical-device collaborative plan sets a four-month total review target for follow-on-device partial-approval applications, measured at the 80th percentile of the application cohort. It is a target for that review category, not a guaranteed duration for all brand, office, succession or combined changes. A30-day minor-notice deadline is a different measure.

The device or its immediate container/wrapper must state: MAH name and address; name; manufacturing lot number or code; content quantity for designated devices; items required by Art. 41(3)/42(2) standards; and the use-by/expiry period for devices designated by MHLW.

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.

The published PMDA medical-device FAQ says each partial-change application incurs its own fee and a second partial application while one is pending should be discussed with the reviewer. Changes with different minor-change dates use separate notices. The FAQ says notifications have no fee; this is notification guidance, not permission to combine every change or an exemption for certification-body service charges.

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.

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 currently linked Japanese fee table lists JPY 182200 for review in the other-medical-device partial-approval category. Its listed conformity-assessment component is JPY 48400 where applicable(totalJPY230600), with JPY 182200 shown where conformity assessment is not required. Adding a sales name has a distinct JPY 37300 review row. These amounts are conditional on that exact application category; other technical review, QMS, travel or certification-body charges may be separate.

Minor (軽微な) changes to approved items are notified to MHLW within 30 days after making the change.

The 2024 medical-device collaborative plan sets a four-month total review target for follow-on-device partial-approval applications, measured at the 80th percentile of the application cohort. It is a target for that review category, not a guaranteed duration for all brand, office, succession or combined changes. A30-day minor-notice deadline is a different measure.

The device or its immediate container/wrapper must state: MAH name and address; name; manufacturing lot number or code; content quantity for designated devices; items required by Art. 41(3)/42(2) standards; and the use-by/expiry period for devices designated by MHLW.

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.

The published PMDA medical-device FAQ says each partial-change application incurs its own fee and a second partial application while one is pending should be discussed with the reviewer. Changes with different minor-change dates use separate notices. The FAQ says notifications have no fee; this is notification guidance, not permission to combine every change or an exemption for certification-body service charges.

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.

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 currently linked Japanese fee table lists JPY 182200 for review in the other-medical-device partial-approval category. Its listed conformity-assessment component is JPY 48400 where applicable(totalJPY230600), with JPY 182200 shown where conformity assessment is not required. Adding a sales name has a distinct JPY 37300 review row. These amounts are conditional on that exact application category; other technical review, QMS, travel or certification-body charges may be separate.

Minor (軽微な) changes to approved items are notified to MHLW within 30 days after making the change.

The 2024 medical-device collaborative plan sets a four-month total review target for follow-on-device partial-approval applications, measured at the 80th percentile of the application cohort. It is a target for that review category, not a guaranteed duration for all brand, office, succession or combined changes. A30-day minor-notice deadline is a different measure.

The device or its immediate container/wrapper must state: MAH name and address; name; manufacturing lot number or code; content quantity for designated devices; items required by Art. 41(3)/42(2) standards; and the use-by/expiry period for devices designated by MHLW.

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.

The published PMDA medical-device FAQ says each partial-change application incurs its own fee and a second partial application while one is pending should be discussed with the reviewer. Changes with different minor-change dates use separate notices. The FAQ says notifications have no fee; this is notification guidance, not permission to combine every change or an exemption for certification-body service charges.

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.

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 currently linked Japanese fee table lists JPY 182200 for review in the other-medical-device partial-approval category. Its listed conformity-assessment component is JPY 48400 where applicable(totalJPY230600), with JPY 182200 shown where conformity assessment is not required. Adding a sales name has a distinct JPY 37300 review row. These amounts are conditional on that exact application category; other technical review, QMS, travel or certification-body charges may be separate.

Minor (軽微な) changes to approved items are notified to MHLW within 30 days after making the change.

The 2024 medical-device collaborative plan sets a four-month total review target for follow-on-device partial-approval applications, measured at the 80th percentile of the application cohort. It is a target for that review category, not a guaranteed duration for all brand, office, succession or combined changes. A30-day minor-notice deadline is a different measure.

The device or its immediate container/wrapper must state: MAH name and address; name; manufacturing lot number or code; content quantity for designated devices; items required by Art. 41(3)/42(2) standards; and the use-by/expiry period for devices designated by MHLW.

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.

The published PMDA medical-device FAQ says each partial-change application incurs its own fee and a second partial application while one is pending should be discussed with the reviewer. Changes with different minor-change dates use separate notices. The FAQ says notifications have no fee; this is notification guidance, not permission to combine every change or an exemption for certification-body service charges.

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.

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 currently linked Japanese fee table lists JPY 182200 for review in the other-medical-device partial-approval category. Its listed conformity-assessment component is JPY 48400 where applicable(totalJPY230600), with JPY 182200 shown where conformity assessment is not required. Adding a sales name has a distinct JPY 37300 review row. These amounts are conditional on that exact application category; other technical review, QMS, travel or certification-body charges may be separate.

Minor (軽微な) changes to approved items are notified to MHLW within 30 days after making the change.

The 2024 medical-device collaborative plan sets a four-month total review target for follow-on-device partial-approval applications, measured at the 80th percentile of the application cohort. It is a target for that review category, not a guaranteed duration for all brand, office, succession or combined changes. A30-day minor-notice deadline is a different measure.

The device or its immediate container/wrapper must state: MAH name and address; name; manufacturing lot number or code; content quantity for designated devices; items required by Art. 41(3)/42(2) standards; and the use-by/expiry period for devices designated by MHLW.

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.

The published PMDA medical-device FAQ says each partial-change application incurs its own fee and a second partial application while one is pending should be discussed with the reviewer. Changes with different minor-change dates use separate notices. The FAQ says notifications have no fee; this is notification guidance, not permission to combine every change or an exemption for certification-body service charges.