South Korea medical device regulations

MD Annex 3 includes the specified product/company trade-name, product-name, model and graphic/trademark edits, with precise conditions; sterile packaging design is excluded from the graphic exemption. Article 19 distinguishes major changes needing technical review, formal changes without technical review, and minor reports. Its ordinary minor-report/annual route has specified compulsory 30-day exceptions for the listed model/name/foreign commissioner-address changes. These applicant deadlines do not become review SLAs and the IVD quarterly rule is not substituted.

Manufacturers and importers must state on the container or outer packaging: (1) business name and address; (2) for imports, country of origin and manufacturer; (3) approval/certification/notification number and names; (4) lot number and manufacture year-month (use-by date may replace it); (5) weight or packaging unit; (6) the marking 의료기기; (7) for single-use, 일회용 and 재사용 금지 markings; (8) the medical device standard code (UDI) set by MFDS in consultation with the Health Minister; (9) notice of electronically provided attachments with website address, where applicable.

Use the actual Form 30 approval, Form 31 certification or Form 7 notification change application, with proof of the changed particulars and technical evidence where required. Site/QMS evidence is conditional on an actual site addition/move, not merely office stationery. Rule 26 expressly asks for an assignment contract in split/merger facility-and-methods succession; the form includes transferor sanctions disclosure and transferee acknowledgement. A foreign-manufacturer identity change does not itself transfer the Korean importer business licence.

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 current product change forms print approval processing periods of 60 days with clinical/technical review, 42 with technical review, and 10 for other changes; certification and notification change forms print 5 days each. Apply the actual required review category and stated procedural clock rules. The source prints days; no unsupported conversion to elapsed calendar days or project lead time is made. Business-licence 15 days and quality-manager 7 days are separate branches.

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.

Article 19-3 permits an applicant-requested authority allowance for up to six months of old-version manufacture/import from the relevant change approval, certification or notification date, in its enumerated categories and conditions. For the listed manufacturer/commissioner name/address cases, the products must already have been manufactured before that approval, certification or notification. Safety/defect/government-action changes are excluded and the permission is recorded. Formal Notice 2026-34 adds notification changes with its commencement/application rule. This is not automatic unrestricted sale or a grace for every brand/REF/legal transfer.

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.

MD Annex 3 includes the specified product/company trade-name, product-name, model and graphic/trademark edits, with precise conditions; sterile packaging design is excluded from the graphic exemption. Article 19 distinguishes major changes needing technical review, formal changes without technical review, and minor reports. Its ordinary minor-report/annual route has specified compulsory 30-day exceptions for the listed model/name/foreign commissioner-address changes. These applicant deadlines do not become review SLAs and the IVD quarterly rule is not substituted.

Use the actual Form 30 approval, Form 31 certification or Form 7 notification change application, with proof of the changed particulars and technical evidence where required. Site/QMS evidence is conditional on an actual site addition/move, not merely office stationery. Rule 26 expressly asks for an assignment contract in split/merger facility-and-methods succession; the form includes transferor sanctions disclosure and transferee acknowledgement. A foreign-manufacturer identity change does not itself transfer the Korean importer business licence.

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 current product change forms print approval processing periods of 60 days with clinical/technical review, 42 with technical review, and 10 for other changes; certification and notification change forms print 5 days each. Apply the actual required review category and stated procedural clock rules. The source prints days; no unsupported conversion to elapsed calendar days or project lead time is made. Business-licence 15 days and quality-manager 7 days are separate branches.

Manufacturers and importers must state on the container or outer packaging: (1) business name and address; (2) for imports, country of origin and manufacturer; (3) approval/certification/notification number and names; (4) lot number and manufacture year-month (use-by date may replace it); (5) weight or packaging unit; (6) the marking 의료기기; (7) for single-use, 일회용 and 재사용 금지 markings; (8) the medical device standard code (UDI) set by MFDS in consultation with the Health Minister; (9) notice of electronically provided attachments with website address, where applicable.

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.

Article 19-3 permits an applicant-requested authority allowance for up to six months of old-version manufacture/import from the relevant change approval, certification or notification date, in its enumerated categories and conditions. For the listed manufacturer/commissioner name/address cases, the products must already have been manufactured before that approval, certification or notification. Safety/defect/government-action changes are excluded and the permission is recorded. Formal Notice 2026-34 adds notification changes with its commencement/application rule. This is not automatic unrestricted sale or a grace for every brand/REF/legal transfer.

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.

MD Annex 3 includes the specified product/company trade-name, product-name, model and graphic/trademark edits, with precise conditions; sterile packaging design is excluded from the graphic exemption. Article 19 distinguishes major changes needing technical review, formal changes without technical review, and minor reports. Its ordinary minor-report/annual route has specified compulsory 30-day exceptions for the listed model/name/foreign commissioner-address changes. These applicant deadlines do not become review SLAs and the IVD quarterly rule is not substituted.

Use the actual Form 30 approval, Form 31 certification or Form 7 notification change application, with proof of the changed particulars and technical evidence where required. Site/QMS evidence is conditional on an actual site addition/move, not merely office stationery. Rule 26 expressly asks for an assignment contract in split/merger facility-and-methods succession; the form includes transferor sanctions disclosure and transferee acknowledgement. A foreign-manufacturer identity change does not itself transfer the Korean importer business licence.

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 current product change forms print approval processing periods of 60 days with clinical/technical review, 42 with technical review, and 10 for other changes; certification and notification change forms print 5 days each. Apply the actual required review category and stated procedural clock rules. The source prints days; no unsupported conversion to elapsed calendar days or project lead time is made. Business-licence 15 days and quality-manager 7 days are separate branches.

Manufacturers and importers must state on the container or outer packaging: (1) business name and address; (2) for imports, country of origin and manufacturer; (3) approval/certification/notification number and names; (4) lot number and manufacture year-month (use-by date may replace it); (5) weight or packaging unit; (6) the marking 의료기기; (7) for single-use, 일회용 and 재사용 금지 markings; (8) the medical device standard code (UDI) set by MFDS in consultation with the Health Minister; (9) notice of electronically provided attachments with website address, where applicable.

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.

Article 19-3 permits an applicant-requested authority allowance for up to six months of old-version manufacture/import from the relevant change approval, certification or notification date, in its enumerated categories and conditions. For the listed manufacturer/commissioner name/address cases, the products must already have been manufactured before that approval, certification or notification. Safety/defect/government-action changes are excluded and the permission is recorded. Formal Notice 2026-34 adds notification changes with its commencement/application rule. This is not automatic unrestricted sale or a grace for every brand/REF/legal transfer.

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.

MD Annex 3 includes the specified product/company trade-name, product-name, model and graphic/trademark edits, with precise conditions; sterile packaging design is excluded from the graphic exemption. Article 19 distinguishes major changes needing technical review, formal changes without technical review, and minor reports. Its ordinary minor-report/annual route has specified compulsory 30-day exceptions for the listed model/name/foreign commissioner-address changes. These applicant deadlines do not become review SLAs and the IVD quarterly rule is not substituted.

Use the actual Form 30 approval, Form 31 certification or Form 7 notification change application, with proof of the changed particulars and technical evidence where required. Site/QMS evidence is conditional on an actual site addition/move, not merely office stationery. Rule 26 expressly asks for an assignment contract in split/merger facility-and-methods succession; the form includes transferor sanctions disclosure and transferee acknowledgement. A foreign-manufacturer identity change does not itself transfer the Korean importer business licence.

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 current product change forms print approval processing periods of 60 days with clinical/technical review, 42 with technical review, and 10 for other changes; certification and notification change forms print 5 days each. Apply the actual required review category and stated procedural clock rules. The source prints days; no unsupported conversion to elapsed calendar days or project lead time is made. Business-licence 15 days and quality-manager 7 days are separate branches.

Manufacturers and importers must state on the container or outer packaging: (1) business name and address; (2) for imports, country of origin and manufacturer; (3) approval/certification/notification number and names; (4) lot number and manufacture year-month (use-by date may replace it); (5) weight or packaging unit; (6) the marking 의료기기; (7) for single-use, 일회용 and 재사용 금지 markings; (8) the medical device standard code (UDI) set by MFDS in consultation with the Health Minister; (9) notice of electronically provided attachments with website address, where applicable.

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.

Article 19-3 permits an applicant-requested authority allowance for up to six months of old-version manufacture/import from the relevant change approval, certification or notification date, in its enumerated categories and conditions. For the listed manufacturer/commissioner name/address cases, the products must already have been manufactured before that approval, certification or notification. Safety/defect/government-action changes are excluded and the permission is recorded. Formal Notice 2026-34 adds notification changes with its commencement/application rule. This is not automatic unrestricted sale or a grace for every brand/REF/legal transfer.

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.

MD Annex 3 includes the specified product/company trade-name, product-name, model and graphic/trademark edits, with precise conditions; sterile packaging design is excluded from the graphic exemption. Article 19 distinguishes major changes needing technical review, formal changes without technical review, and minor reports. Its ordinary minor-report/annual route has specified compulsory 30-day exceptions for the listed model/name/foreign commissioner-address changes. These applicant deadlines do not become review SLAs and the IVD quarterly rule is not substituted.

Use the actual Form 30 approval, Form 31 certification or Form 7 notification change application, with proof of the changed particulars and technical evidence where required. Site/QMS evidence is conditional on an actual site addition/move, not merely office stationery. Rule 26 expressly asks for an assignment contract in split/merger facility-and-methods succession; the form includes transferor sanctions disclosure and transferee acknowledgement. A foreign-manufacturer identity change does not itself transfer the Korean importer business licence.

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 current product change forms print approval processing periods of 60 days with clinical/technical review, 42 with technical review, and 10 for other changes; certification and notification change forms print 5 days each. Apply the actual required review category and stated procedural clock rules. The source prints days; no unsupported conversion to elapsed calendar days or project lead time is made. Business-licence 15 days and quality-manager 7 days are separate branches.

Manufacturers and importers must state on the container or outer packaging: (1) business name and address; (2) for imports, country of origin and manufacturer; (3) approval/certification/notification number and names; (4) lot number and manufacture year-month (use-by date may replace it); (5) weight or packaging unit; (6) the marking 의료기기; (7) for single-use, 일회용 and 재사용 금지 markings; (8) the medical device standard code (UDI) set by MFDS in consultation with the Health Minister; (9) notice of electronically provided attachments with website address, where applicable.

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.

Article 19-3 permits an applicant-requested authority allowance for up to six months of old-version manufacture/import from the relevant change approval, certification or notification date, in its enumerated categories and conditions. For the listed manufacturer/commissioner name/address cases, the products must already have been manufactured before that approval, certification or notification. Safety/defect/government-action changes are excluded and the permission is recorded. Formal Notice 2026-34 adds notification changes with its commencement/application rule. This is not automatic unrestricted sale or a grace for every brand/REF/legal transfer.

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.

MD Annex 3 includes the specified product/company trade-name, product-name, model and graphic/trademark edits, with precise conditions; sterile packaging design is excluded from the graphic exemption. Article 19 distinguishes major changes needing technical review, formal changes without technical review, and minor reports. Its ordinary minor-report/annual route has specified compulsory 30-day exceptions for the listed model/name/foreign commissioner-address changes. These applicant deadlines do not become review SLAs and the IVD quarterly rule is not substituted.

Use the actual Form 30 approval, Form 31 certification or Form 7 notification change application, with proof of the changed particulars and technical evidence where required. Site/QMS evidence is conditional on an actual site addition/move, not merely office stationery. Rule 26 expressly asks for an assignment contract in split/merger facility-and-methods succession; the form includes transferor sanctions disclosure and transferee acknowledgement. A foreign-manufacturer identity change does not itself transfer the Korean importer business licence.

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 current product change forms print approval processing periods of 60 days with clinical/technical review, 42 with technical review, and 10 for other changes; certification and notification change forms print 5 days each. Apply the actual required review category and stated procedural clock rules. The source prints days; no unsupported conversion to elapsed calendar days or project lead time is made. Business-licence 15 days and quality-manager 7 days are separate branches.

Manufacturers and importers must state on the container or outer packaging: (1) business name and address; (2) for imports, country of origin and manufacturer; (3) approval/certification/notification number and names; (4) lot number and manufacture year-month (use-by date may replace it); (5) weight or packaging unit; (6) the marking 의료기기; (7) for single-use, 일회용 and 재사용 금지 markings; (8) the medical device standard code (UDI) set by MFDS in consultation with the Health Minister; (9) notice of electronically provided attachments with website address, where applicable.

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.

Article 19-3 permits an applicant-requested authority allowance for up to six months of old-version manufacture/import from the relevant change approval, certification or notification date, in its enumerated categories and conditions. For the listed manufacturer/commissioner name/address cases, the products must already have been manufactured before that approval, certification or notification. Safety/defect/government-action changes are excluded and the permission is recorded. Formal Notice 2026-34 adds notification changes with its commencement/application rule. This is not automatic unrestricted sale or a grace for every brand/REF/legal transfer.

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.