South Korea medical device regulations

The current MD/IVD fee tables list other product change approval at KRW 121000 electronic/135000 visit-post where that category applies. Business-change branches are different: site 45000/50000, representative transfer/inheritance 81000/90000, quality-manager 27000/30000. These are not universal fees for changing a foreign manufacturer name or a model; select the actual application and legal actor. Major clinical/document and certification/notification rows remain distinct.

The UDI rule expressly covers MDs and IVDs and excludes export-only products. It assigns codes by model/product-name and packaging level. The current regeneration rule includes domestic-manufactured product-only assignment excluding the business licence, packaging-unit and stated single-use/sterility changes; the old item 2 is deleted. A commercial REF or foreign-company name alone does not establish that domestic-assignment trigger. Match actual approved model and code records before deciding the UDI consequence.

Use Form 18 for the actual important product change and Form 17 for the business change, with the changed-particular evidence, technical evidence where the actual category requires it, and assignment contract for the specified succession branch. The actual forms include transferor administrative-sanction disclosure/transferee acceptance. A no-technical-review assignment/site branch still has a formal change route; quarterly minor reporting is not a substitute.

Current Form 18 prints approval change periods 60 days with clinical/technical review, 42 with technical review, 10 for other changes, and 5 days each for certification/notification. Form 17 business-licence 15 days/quality-manager 7 days is separate. Applicant 30-day important-change filings, quarterly minor reports, query responses and clock resumption are not these product-review periods. The printed days are not converted to an unsupported elapsed-day unit.

IVD Act 13 applies the listed MD Act 20 label particulars with its express exception and adds the IVD marking, intended use and storage conditions. Therefore align actual manufacturer/importer, product/model and authorisation identity under that bridge; this is direct IVD statutory evidence rather than an assumption from ordinary MD labels. It creates no general old-label sell-through right.

KRW 551,000–612,000

Per application

Base tariff: electronic application KRW 551,000; visit/post application KRW 612,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(b) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 1,009,000–1,122,000

Per application

Base tariff: electronic application KRW 1,009,000; visit/post application KRW 1,122,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(a) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 82,000–93,000

Per application

Base tariff: electronic application KRW 82,000; visit/post application KRW 93,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item8 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 39,000–43,000

Per notification

Base tariff: electronic application KRW 39,000; visit/post application KRW 43,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item9 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

The current MD/IVD fee tables list other product change approval at KRW 121000 electronic/135000 visit-post where that category applies. Business-change branches are different: site 45000/50000, representative transfer/inheritance 81000/90000, quality-manager 27000/30000. These are not universal fees for changing a foreign manufacturer name or a model; select the actual application and legal actor. Major clinical/document and certification/notification rows remain distinct.

The UDI rule expressly covers MDs and IVDs and excludes export-only products. It assigns codes by model/product-name and packaging level. The current regeneration rule includes domestic-manufactured product-only assignment excluding the business licence, packaging-unit and stated single-use/sterility changes; the old item 2 is deleted. A commercial REF or foreign-company name alone does not establish that domestic-assignment trigger. Match actual approved model and code records before deciding the UDI consequence.

Use Form 18 for the actual important product change and Form 17 for the business change, with the changed-particular evidence, technical evidence where the actual category requires it, and assignment contract for the specified succession branch. The actual forms include transferor administrative-sanction disclosure/transferee acceptance. A no-technical-review assignment/site branch still has a formal change route; quarterly minor reporting is not a substitute.

Current Form 18 prints approval change periods 60 days with clinical/technical review, 42 with technical review, 10 for other changes, and 5 days each for certification/notification. Form 17 business-licence 15 days/quality-manager 7 days is separate. Applicant 30-day important-change filings, quarterly minor reports, query responses and clock resumption are not these product-review periods. The printed days are not converted to an unsupported elapsed-day unit.

IVD Act 13 applies the listed MD Act 20 label particulars with its express exception and adds the IVD marking, intended use and storage conditions. Therefore align actual manufacturer/importer, product/model and authorisation identity under that bridge; this is direct IVD statutory evidence rather than an assumption from ordinary MD labels. It creates no general old-label sell-through right.

KRW 551,000–612,000

Per application

Base tariff: electronic application KRW 551,000; visit/post application KRW 612,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(b) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 1,009,000–1,122,000

Per application

Base tariff: electronic application KRW 1,009,000; visit/post application KRW 1,122,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(a) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 82,000–93,000

Per application

Base tariff: electronic application KRW 82,000; visit/post application KRW 93,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item8 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 39,000–43,000

Per notification

Base tariff: electronic application KRW 39,000; visit/post application KRW 43,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item9 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

The current MD/IVD fee tables list other product change approval at KRW 121000 electronic/135000 visit-post where that category applies. Business-change branches are different: site 45000/50000, representative transfer/inheritance 81000/90000, quality-manager 27000/30000. These are not universal fees for changing a foreign manufacturer name or a model; select the actual application and legal actor. Major clinical/document and certification/notification rows remain distinct.

The UDI rule expressly covers MDs and IVDs and excludes export-only products. It assigns codes by model/product-name and packaging level. The current regeneration rule includes domestic-manufactured product-only assignment excluding the business licence, packaging-unit and stated single-use/sterility changes; the old item 2 is deleted. A commercial REF or foreign-company name alone does not establish that domestic-assignment trigger. Match actual approved model and code records before deciding the UDI consequence.

Use Form 18 for the actual important product change and Form 17 for the business change, with the changed-particular evidence, technical evidence where the actual category requires it, and assignment contract for the specified succession branch. The actual forms include transferor administrative-sanction disclosure/transferee acceptance. A no-technical-review assignment/site branch still has a formal change route; quarterly minor reporting is not a substitute.

Current Form 18 prints approval change periods 60 days with clinical/technical review, 42 with technical review, 10 for other changes, and 5 days each for certification/notification. Form 17 business-licence 15 days/quality-manager 7 days is separate. Applicant 30-day important-change filings, quarterly minor reports, query responses and clock resumption are not these product-review periods. The printed days are not converted to an unsupported elapsed-day unit.

IVD Act 13 applies the listed MD Act 20 label particulars with its express exception and adds the IVD marking, intended use and storage conditions. Therefore align actual manufacturer/importer, product/model and authorisation identity under that bridge; this is direct IVD statutory evidence rather than an assumption from ordinary MD labels. It creates no general old-label sell-through right.

KRW 551,000–612,000

Per application

Base tariff: electronic application KRW 551,000; visit/post application KRW 612,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(b) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 1,009,000–1,122,000

Per application

Base tariff: electronic application KRW 1,009,000; visit/post application KRW 1,122,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(a) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 82,000–93,000

Per application

Base tariff: electronic application KRW 82,000; visit/post application KRW 93,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item8 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 39,000–43,000

Per notification

Base tariff: electronic application KRW 39,000; visit/post application KRW 43,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item9 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

The current MD/IVD fee tables list other product change approval at KRW 121000 electronic/135000 visit-post where that category applies. Business-change branches are different: site 45000/50000, representative transfer/inheritance 81000/90000, quality-manager 27000/30000. These are not universal fees for changing a foreign manufacturer name or a model; select the actual application and legal actor. Major clinical/document and certification/notification rows remain distinct.

The UDI rule expressly covers MDs and IVDs and excludes export-only products. It assigns codes by model/product-name and packaging level. The current regeneration rule includes domestic-manufactured product-only assignment excluding the business licence, packaging-unit and stated single-use/sterility changes; the old item 2 is deleted. A commercial REF or foreign-company name alone does not establish that domestic-assignment trigger. Match actual approved model and code records before deciding the UDI consequence.

Use Form 18 for the actual important product change and Form 17 for the business change, with the changed-particular evidence, technical evidence where the actual category requires it, and assignment contract for the specified succession branch. The actual forms include transferor administrative-sanction disclosure/transferee acceptance. A no-technical-review assignment/site branch still has a formal change route; quarterly minor reporting is not a substitute.

Current Form 18 prints approval change periods 60 days with clinical/technical review, 42 with technical review, 10 for other changes, and 5 days each for certification/notification. Form 17 business-licence 15 days/quality-manager 7 days is separate. Applicant 30-day important-change filings, quarterly minor reports, query responses and clock resumption are not these product-review periods. The printed days are not converted to an unsupported elapsed-day unit.

IVD Act 13 applies the listed MD Act 20 label particulars with its express exception and adds the IVD marking, intended use and storage conditions. Therefore align actual manufacturer/importer, product/model and authorisation identity under that bridge; this is direct IVD statutory evidence rather than an assumption from ordinary MD labels. It creates no general old-label sell-through right.

KRW 551,000–612,000

Per application

Base tariff: electronic application KRW 551,000; visit/post application KRW 612,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(b) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 1,009,000–1,122,000

Per application

Base tariff: electronic application KRW 1,009,000; visit/post application KRW 1,122,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(a) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 82,000–93,000

Per application

Base tariff: electronic application KRW 82,000; visit/post application KRW 93,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item8 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 39,000–43,000

Per notification

Base tariff: electronic application KRW 39,000; visit/post application KRW 43,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item9 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

The current MD/IVD fee tables list other product change approval at KRW 121000 electronic/135000 visit-post where that category applies. Business-change branches are different: site 45000/50000, representative transfer/inheritance 81000/90000, quality-manager 27000/30000. These are not universal fees for changing a foreign manufacturer name or a model; select the actual application and legal actor. Major clinical/document and certification/notification rows remain distinct.

The UDI rule expressly covers MDs and IVDs and excludes export-only products. It assigns codes by model/product-name and packaging level. The current regeneration rule includes domestic-manufactured product-only assignment excluding the business licence, packaging-unit and stated single-use/sterility changes; the old item 2 is deleted. A commercial REF or foreign-company name alone does not establish that domestic-assignment trigger. Match actual approved model and code records before deciding the UDI consequence.

Use Form 18 for the actual important product change and Form 17 for the business change, with the changed-particular evidence, technical evidence where the actual category requires it, and assignment contract for the specified succession branch. The actual forms include transferor administrative-sanction disclosure/transferee acceptance. A no-technical-review assignment/site branch still has a formal change route; quarterly minor reporting is not a substitute.

Current Form 18 prints approval change periods 60 days with clinical/technical review, 42 with technical review, 10 for other changes, and 5 days each for certification/notification. Form 17 business-licence 15 days/quality-manager 7 days is separate. Applicant 30-day important-change filings, quarterly minor reports, query responses and clock resumption are not these product-review periods. The printed days are not converted to an unsupported elapsed-day unit.

IVD Act 13 applies the listed MD Act 20 label particulars with its express exception and adds the IVD marking, intended use and storage conditions. Therefore align actual manufacturer/importer, product/model and authorisation identity under that bridge; this is direct IVD statutory evidence rather than an assumption from ordinary MD labels. It creates no general old-label sell-through right.

KRW 551,000–612,000

Per application

Base tariff: electronic application KRW 551,000; visit/post application KRW 612,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(b) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 1,009,000–1,122,000

Per application

Base tariff: electronic application KRW 1,009,000; visit/post application KRW 1,122,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(a) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 82,000–93,000

Per application

Base tariff: electronic application KRW 82,000; visit/post application KRW 93,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item8 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 39,000–43,000

Per notification

Base tariff: electronic application KRW 39,000; visit/post application KRW 43,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item9 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

The current MD/IVD fee tables list other product change approval at KRW 121000 electronic/135000 visit-post where that category applies. Business-change branches are different: site 45000/50000, representative transfer/inheritance 81000/90000, quality-manager 27000/30000. These are not universal fees for changing a foreign manufacturer name or a model; select the actual application and legal actor. Major clinical/document and certification/notification rows remain distinct.

The UDI rule expressly covers MDs and IVDs and excludes export-only products. It assigns codes by model/product-name and packaging level. The current regeneration rule includes domestic-manufactured product-only assignment excluding the business licence, packaging-unit and stated single-use/sterility changes; the old item 2 is deleted. A commercial REF or foreign-company name alone does not establish that domestic-assignment trigger. Match actual approved model and code records before deciding the UDI consequence.

Use Form 18 for the actual important product change and Form 17 for the business change, with the changed-particular evidence, technical evidence where the actual category requires it, and assignment contract for the specified succession branch. The actual forms include transferor administrative-sanction disclosure/transferee acceptance. A no-technical-review assignment/site branch still has a formal change route; quarterly minor reporting is not a substitute.

Current Form 18 prints approval change periods 60 days with clinical/technical review, 42 with technical review, 10 for other changes, and 5 days each for certification/notification. Form 17 business-licence 15 days/quality-manager 7 days is separate. Applicant 30-day important-change filings, quarterly minor reports, query responses and clock resumption are not these product-review periods. The printed days are not converted to an unsupported elapsed-day unit.

IVD Act 13 applies the listed MD Act 20 label particulars with its express exception and adds the IVD marking, intended use and storage conditions. Therefore align actual manufacturer/importer, product/model and authorisation identity under that bridge; this is direct IVD statutory evidence rather than an assumption from ordinary MD labels. It creates no general old-label sell-through right.

KRW 551,000–612,000

Per application

Base tariff: electronic application KRW 551,000; visit/post application KRW 612,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(b) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 1,009,000–1,122,000

Per application

Base tariff: electronic application KRW 1,009,000; visit/post application KRW 1,122,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(a) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 82,000–93,000

Per application

Base tariff: electronic application KRW 82,000; visit/post application KRW 93,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item8 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.

KRW 39,000–43,000

Per notification

Base tariff: electronic application KRW 39,000; visit/post application KRW 43,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item9 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row.