🇰🇷 South Korea medical device regulatory data

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 was accepted.

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 certificate keeps its effect.

Renewal applications are filed 270 to 180 days before the expiry date (per e-Medis official guidance; the Act itself only requires renewal before expiry and delegates procedure to the Prime Ministerial Decree).

Archetype

Licensed Importer As Applicant

Name

Korean licensed importer / product authorisation holder

Required For Foreign

yes

Registration Relation

Foreign Device Enters Through Licensed Importer

Importer Relation

Same Core Local Role

Distributor Relation

May Be Separate

Combination

Allowed Subject To Business Licences

Detail

The importer must hold an import business licence from MFDS and is the party that obtains the product-level import approval/certification/notification.

Manufacturing medical devices as a business requires a manufacturing business licence (제조업허가) from the MFDS Commissioner.

Selling or leasing medical devices is a notified business (판매·임대업 신고) with an official notification form (의료기기 판매(임대)업 신고서, [서식 36]) and a notification fee under Enforcement Rule Annex 10.

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 adverse-event reports.

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 the fact.

Medical Device Act (의료기기법), Law No. 21263 of 2025-12-30, in force from 2026-07-01, is the primary statute.

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 standards [별표 2], clinical trial management standards [별표 3], import-establishment standards [별표 4], distribution quality management [별표 6], prohibited advertising scope [별표 7], fees [별표 10] and official forms [서식 1-56].

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, alleviation, treatment or prevention of disease (among other listed purposes).

Manufacturers obtain product-level manufacturing approval (제조허가), manufacturing certification (제조인증) or file manufacturing notification (제조신고). Devices with very low potential harm notified by MFDS are handled per product family (품목류별); all other devices per individual item (품목별).

Importers must obtain import approval (수입허가) or import certification (수입인증), or file import notification (수입신고), for each device they import.

Per-item approval (허가) targets Class 3 and 4 devices, plus listed Class 1-2 exceptions: devices combined with drugs/quasi-drugs, u-healthcare devices, continuously worn respiratory monitors, devices not substantially equivalent or requiring clinical-trial data, devices without notified sub-classification, and new-medical-technology-integrated-review devices.

Market entry follows the class route: Class 1 notification, Class 2 certification, Class 3-4 approval, plus KGMP conformity certification (적합성인정) for the manufacturer/importer as a prerequisite; Class 1 low-risk items may be notified per product family.

Target

geo:kor

SourceApproval

Medical Device Single Audit Program (MDSAP)

EdgeType

Qms Audit Reliance

MarketAccessStrength

Evidence Only

RegulatoryLayer

Qms Audit

LocalApplicationRequired

Yes

TargetDecisionRetained

Yes

Detail

MFDS guideline (민원인안내서 MDSAP 심사결과 활용 가이드라인, 안내서-1349-01, 2024-02-23) governs use of MDSAP audit results when MFDS performs device GMP reviews; it is evidence reuse and does not replace Korean authorisation.

Before applying for import approval/certification or filing import notification, the importer must already have the facilities and manufacturing/quality-management system required for quality inspection under the Prime Ministerial Decree.

Approval applications include, where applicable, the technical-documentation review result notification (기술문서 등의 심사결과통지서) among the required attachments, linking the separate technical-document review to the product application.

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.

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.

Manufacturing-licence applicants/manufacturers and import-business applicants/importers must obtain KGMP conformity certification (적합성인정). The certificate is valid 3 years from issuance; changes such as manufacturing-site (including overseas site) relocation require change conformity certification, and the certificate must be renewed before expiry.

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 Rule Annex 2; ISO 13485-aligned but retained as national conformity.

Iso Role

Plain ISO 13485 does not replace KGMP conformity certification.

Mdsap Role

Affiliate Audit Report And Certificate Use

Mdsap Detail

MFDS guideline (2024) governs reuse of MDSAP audit results in GMP reviews.

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; the procedures and criteria are delegated to the Prime Ministerial Decree.

MFDS may build and operate an electronic information system (의료기기통합정보시스템) that records and manages device information from approval through manufacture, import, distribution and use.

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 information system; MFDS administrative rule 「의료기기 표준코드의 표시 및 관리요령」 (고시 제2023-67호) details marking and management.

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 standards (or imported correspondingly).

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 clock for clinical-data cases at 80 days versus 65 days for technical-document-only cases.

Investigational medical devices for clinical trials may be manufactured or imported without product approval, certification or notification, provided they are made in facilities meeting Prime-Ministerial-Decree criteria (and the trial plan is approved).

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 Prime Ministerial Decree.

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 that range through the Medical Device Committee.

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 must be taken within 30 days.

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 records.

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 serious outcomes (hospitalisation or extension, permanent disability/function loss, congenital anomaly, etc.) within 15 days.

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 may publicise the fact; the standards, methods and publicity methods for hazard-degree-based suspension/recall/disposal are delegated to the Prime Ministerial Decree.

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 report (회수종료보고서, [서식 48]).

Ads for medical devices using enumerated media (TV/radio broadcasting, daily/weekly/internet newspapers, magazines, banners/posters/leaflets, electronic boards, internet media) must undergo prior deliberation (자율심의) on whether they violate Article 24(2)-(3); deliberation is performed by a self-deliberation body registered with MFDS under Article 25-2.

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 a medical device.

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 result may file an objection (이의신청) with the MFDS Commissioner within 30 days of notice.

During preliminary review (예비심사검토) of an application, missing attachment items may be submitted within 5 days.