MFDS market access

South Korea medical device registration resources

Research MFDS registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every South Korea medical device resource.

197,939 license records11 free resources25/25 requirements covered4 regulations trackedAug 2026 fees reviewed

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Medical device registration database

Search official MFDS device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official MFDS regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current MFDS application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely MFDS pathway, government fees, dossier preparation time, review timeline, and registration steps.

AI medical device classifier

Describe your device and get a preliminary MFDS risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other South Korea requirements.

AI similar registered product finder

Describe a device and find comparable products in the MFDS registration database.

Medical device regulation news

Follow recent MFDS policy, guidance, safety, and compliance updates.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 39 source-linked facts →

25 of 25 research dimensions currently covered · 27 official sources · latest verification 2026-08-30

Market entry

D01

Authority & regime

Verified

Competent authority: MFDS (식품의약품안전처, Ministry of Food and Drug Safety) is the competent authority: it grants manufacturing business licences, product approvals/certifications and import licences, and receives a…
Local-government market-surveillance powers: Besides MFDS, special self governing city/province mayors and city/county/district heads can order sales suspension, recall, disposal or other measures for hazardous devices and publicise t…

2 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Primary legislation: Medical Device Act (의료기기법), Law No. 21263 of 2025 12 30, in force from 2026 07 01, is the primary statute.
Subordinate legislation: Medical Device Act Enforcement Rule (의료기기법 시행규칙), Prime Ministerial Decree No. 2127, in force from 2026 07 01, carries the annexes: grade classification criteria [별표 1], facility and QMS st…

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Device definition and scope: A medical device (의료기기) is any instrument, machine, apparatus, material or software or similar product used alone or in combination on humans or animals for diagnosis, treatment, alleviatio…

1 source-linked fact

Checked 2026-08-25

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D04

Classification rules

Verified

Risk classes I through IV.: Class I, Class II, Class III, Class IV

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Manufacturing authorisation routes: Manufacturers obtain product level manufacturing approval (제조허가), manufacturing certification (제조인증) or file manufacturing notification (제조신고). Devices with very low potential harm notified…
Import authorisation routes: Importers must obtain import approval (수입허가) or import certification (수입인증), or file import notification (수입신고), for each device they import.

4 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

MDSAP audit-result reliance (QMS): target: geo:kor · sourceApproval: Medical Device Single Audit Program (MDSAP) · edgeType: qms audit reliance · marketAccessStrength: evidence only · regulatoryLayer: qms audit · localApplic…

1 source-linked fact

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Local market-entry role: archetype: licensed importer as applicant · name: Korean licensed importer / product authorisation holder · required for foreign: yes · registration relation: foreign device enters through…
Manufacturer licence requirement: Manufacturing medical devices as a business requires a manufacturing business licence (제조업허가) from the MFDS Commissioner.

3 source-linked facts

Checked 2026-08-26

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D08

Establishment, import & distribution

Verified

Import establishment prerequisites: Before applying for import approval/certification or filing import notification, the importer must already have the facilities and manufacturing/quality management system required for quali…

1 source-linked fact

Checked 2026-08-25

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D09

Dossier requirements

Verified

Technical documentation review in dossier: Approval applications include, where applicable, the technical documentation review result notification (기술문서 등의 심사결과통지서) among the required attachments, linking the separate technical docu…

1 source-linked fact

Checked 2026-08-25

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D10

Official forms & portals

Verified

Electronic submission portal: e Medis (의료기기전자민원시스템, emedi.mfds.go.kr) is the official electronic civil affairs system through which product permits/certifications/notifications and renewals are filed and processed.

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Container/outer-packaging marking items: 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/no…

1 source-linked fact

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

KGMP conformity certification: Manufacturing licence applicants/manufacturers and import business applicants/importers must obtain KGMP conformity certification (적합성인정). The certificate is valid 3 years from issuance; ch…
QMS and audit evidence for market access: iso relation: national qms aligned with iso additions · local regime: KGMP: national conformity certification (적합성인정) under Article 28 of the Act with facility/QMS standards in Enforcement…

2 source-linked facts

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Verified

MFDS electrical/EMC evidence: Electrical safety
RRA KC conformity certification/registration/interim certification: Wireless / radio
Safety Korea product-safety KC: Adapters / components

3 maintained overlays

Checked 2026-08-29

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D14

Fees

Verified

Product application without technical review: KRW 158,000–176,000
Product application with technical documents: KRW 719,000–799,000

21 maintained fee lines

Checked 2026-08-25

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D15

Review clocks

Verified

Class I (1등급) · Manufacture/import notification (제조·수입 신고): 0 days
Class II (2등급) · Certification (인증) by the Korea Institute of Medical Device Safety Information: 5 working days
Approval — no technical-document review · MFDS approval (허가): 10 working days

5 maintained pathways

Checked 2026-08-30

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D16

Approval validity & renewal

Verified

Authorization duration: type: fixed term · description: Manufacturing approval, certification or notification (제조허가등) is valid for 5 years from the date the approval/certification was granted or the notification w…
Expiry or lapse consequence: The holder must renew the approval/certification/notification with the MFDS Commissioner before the 5 year validity ends; on renewal the validity is newly granted for 5 years and the permit…

3 source-linked facts

Checked 2026-08-26

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Lifecycle & post-market

D17

Change control

Verified

Change-control routes: Changes to approved/certified/notified particulars (e.g. location changes) require change approval (변경허가), change certification (변경인증) or change notification (변경신고) to the MFDS Commissioner…

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Integrated device information system: MFDS may build and operate an electronic information system (의료기기통합정보시스템) that records and manages device information from approval through manufacture, import, distribution and use.
UDI (standard code) registration duty: Manufacturers/importers (제조업자등) must register the medical device standard code (의료기기 표준코드, i.e. UDI) and device information prescribed by Prime Ministerial Decree into the integrated device…

2 source-linked facts

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical trial plan approval: Clinical trials of medical devices run under an MFDS approved clinical trial plan (임상시험계획 승인); investigational devices must be manufactured in facilities meeting Prime Ministerial Decree st…
Local clinical-data triggers: Devices that are not substantially equivalent, or for which clinical trial data submission is required, need approval (even in Class 1 2) with clinical data; e Medis shows the approval cloc…

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Investigational-device exemption: Investigational medical devices for clinical trials may be manufactured or imported without product approval, certification or notification, provided they are made in facilities meeting Pri…
Ban on unapproved devices: No person may repair, sell, lease, gift or use devices lacking the approval, certification or notification required under Articles 6(2) or 15(2); an exhibition exception is delegated to the…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Post-market survey and re-examination period: At product approval MFDS sets the post market survey (시판 후 조사) period, generally 3 months; the re examination (재심사) period runs within 4 to 7 years after approval and may be extended within…
PMS result reporting deadline: Re examination target manufacturers/importers report survey results annually, within 2 months after each 1 year period from the marketing date; after result notification, follow up measures…

2 source-linked facts

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Act-level reporting duty: Device handlers (의료기기취급자) who become aware of death or serious adverse effects occurring or likely to occur during device use must report immediately to the MFDS Commissioner and keep recor…
Vigilance reporting deadlines: Under Enforcement Rule Article 51: death or life threatening adverse effects must be reported within 7 days, with a detailed follow up report within 8 days of the first report; other seriou…

2 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Recall and suspension order authority: MFDS (or the listed local government heads) order manufacturers etc., by hazard degree, to suspend sales, recall, dispose of by public health protective means, or take other measures, and m…
Recall reporting forms: The Enforcement Rule prescribes official recall forms: recall plan (회수계획서, [서식 43]), recall confirmation (회수확인서, [서식 44]), recall evaluation report (회수평가보고서, [서식 45]) and recall termination…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Prior advertising self-deliberation: Ads for medical devices using enumerated media (TV/radio broadcasting, daily/weekly/internet newspapers, magazines, banners/posters/leaflets, electronic boards, internet media) must undergo…
Quasi-device advertising ban: No one may mark or advertise non device products on their exterior, packaging or accompanying documents in a way likely to mislead that they have performance, efficacy or effects similar to…

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Advertising deliberation appeal: An advertiser disagreeing with a deliberation result may request re deliberation (재심의) to the self deliberation body within 30 days of notice; a person disagreeing with the re deliberation…
Preliminary-review supplement window: During preliminary review (예비심사검토) of an application, missing attachment items may be submitted within 5 days.

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (21 lines) →

MFDS registration fees in KRW · reviewed 2026-08-25

Fee line	Amount	Provenance
Product application without technical review	KRW 158,000–176,000	Verified
Product application with technical documents	KRW 719,000–799,000	Verified
Product application with clinical data	KRW 1,495,000–1,662,000	Verified
Separate technical-document evaluation	KRW 561,000–624,000	Verified

17 more fee lines on the full schedule · 21 of 21 rows source-verified

Registration timeline

Full registration timeline →

Ministry of Food and Drug Safety (MFDS) review clocks and planning ranges · 4-class (I, II, III, IV) classification

Class / pathway	Review clock	Planning total	Provenance
Class I (1등급)(Manufacture/import notification (제조·수입 신고))	0 days	0 days	Verified
Class II (2등급)(Certification (인증) by the Korea Institute of Medical Device Safety Information)	5 working days	3-6 months	Verified
Approval — no technical-document review(MFDS approval (허가))	10 working days	10-20 working days	Verified
Approval — technical-document review(MFDS approval (허가))	65 working days	6-12 months	Verified