Korea Medical Device Approval Lookup (MFDS 의료기기 품목허가)

Check whether a medical device is approved, certified or notified for sale in South Korea, using the official product approval list of the Ministry of Food and Drug Safety (식품의약품안전처, MFDS) — about 214,000 device records since 1998, updated daily. Each record gives:

• the approval number and date, and the regulatory pathway — approval (허가), certification (인증) or notification (신고) — plus whether the device is made in Korea or imported and whether it is an in-vitro diagnostic
• the Korean risk class (1-4) and MFDS classification code
• the Korean license holder (manufacturer or importer) and its business registration number
• the legal manufacturer / brand owner and the manufacturing site for imported and contract-made devices (usually in English, e.g. Becton, Dickinson and Company)
• the registered models, the intended use, and whether the approval is still active

Search by Korean company, business number, device name, model number or approval number — or leave every filter empty to get the newest approvals (a daily feed of what MFDS approved this week). No API key or Korean account needed.

Typical uses

• Regulatory affairs (RA) consultants and foreign manufacturers — confirm that a competitor's or partner's device is registered in Korea, and under which class and pathway.
• Distributors, hospitals and e-commerce platforms — verify the approval number a seller quotes before listing or buying a device.
• Market intelligence — watch new Korean approvals by device type or company every week.
• AI agents — "Is Medtronic's model 8815642001 still registered in Korea?", "What medical devices did MFDS approve this week?"

Input

Field	Description
companyName	Part of the Korean license holder name, e.g. 메드트로닉 (Medtronic Korea). Spaces are ignored; leave out (주)/(유).
businessNumber	10-digit business registration number of the license holder, e.g. 120-86-07387.
productName	Part of the Korean generic device name, e.g. 봉합사 (suture), 스텐트 (stent).
modelName	Part of a registered model name or catalogue number, e.g. 8815642001.
approvalNumber	MFDS number, e.g. 제허 26-745 호 or 수인20-4327호 (spaces optional).
approvedWithinDays	Only approvals dated in the last N days. With no other filter: newest approvals, default 7, at most 365. With a filter: optional (all years).
activeOnly	true = leave out cancelled, withdrawn or lapsed approvals. Default false.
maxResults	Stop after this many records, newest approval first (1-1000). Default 50.

Filters combine (AND). Examples:

{ "companyName": "메드트로닉", "modelName": "8815642001" }

{ "approvedWithinDays": 7, "maxResults": 300 }

Output

One item per approval record, newest approval first:

{
  "status": "active",
  "productName": "유세포분석용혈구검사시약",
  "approvalNumber": "체외 수인 26-4702 호",
  "approvalDate": "2026-10-08",
  "pathway": "certification",
  "pathwayKo": "인증",
  "origin": "imported",
  "inVitroDiagnostic": true,
  "riskClass": 2,
  "classificationCode": "J09040.01",
  "models": "664452",
  "intendedUse": "사람의 말초혈액(EDTA처리 전혈)에서 CD117 항원 발현세포의 백분율을 유세포분석법으로 정성하여 혈액성분분석에 도움을 주는 체외진단의료기기",
  "licenseHolder": "벡톤디킨슨코리아(주)",
  "businessNumber": "201-81-45458",
  "legalManufacturer": "Becton, Dickinson and Company, BD Biosciences",
  "manufacturingSite": "Becton Dickinson Caribe, Ltd.",
  "inactive": null,
  "itemSeq": "2026006972",
  "lastChanged": "2026-10-08",
  "source": "Ministry of Food and Drug Safety (식품의약품안전처) medical device product approval list, via data.go.kr 15057456",
  "checkedAt": "2026-10-12T13:40:11+00:00"
}

status	Meaning
active	The approval is in force (billed).
inactive	The approval was cancelled, withdrawn or has lapsed; inactive.code and inactive.date say when (billed).
lookup_failed	The official list did not answer; retry later (free).

An invalid input (malformed business or approval number, out-of-range numbers) stops the run with a message and is free. No match means an empty result and no charge.

Field notes:

• pathway and origin are read from the approval number: 제 = made in Korea, 수 = imported; 허 = approval (mostly class 3-4), 인 = certification (class 2), 신 = notification (class 1). Very old numbers without the 제/수 prefix give origin: null.
• legalManufacturer is the company that ordered the manufacture (제조의뢰자) — for imports usually the foreign brand owner; manufacturingSite is the producer (제조자). Both are empty for most devices made in Korea.
• models is the model list as published; long lists end with 외 N건 (= "and N more").

Limits — what is not included

• Search terms must be Korean (company and device names), except model numbers and approval numbers. Foreign manufacturer names (e.g. "Medtronic") are returned but cannot be searched at the source — search the Korean importer (메드트로닉) or a model number instead.
• Device names, intended use and company names are in Korean, as published; field names and labels are English.
• MFDS does not publish the meaning of the inactive codes (inactive.code 1, 2, 5, 6), so the Actor reports them as-is rather than guessing between cancellation, withdrawal and expiry. In the data, code 5 records typically end exactly five years after approval (lapsed without renewal).
• Not included: UDI/barcodes, approval conditions and attached documents, change history, recalls (see Korea Drug & Medical Device Recalls) and GMP certificates.
• A run reads at most 15,000 source rows; very broad searches (e.g. one letter of a device name) stop there — narrow the filters.

Pricing

Pay per record returned: $0.002 per device approval record (device-record), active or inactive. Use maxResults to cap a run. Empty results, invalid inputs and failed lookups are free.

Use as an MCP tool (Claude, Cursor, other AI agents)

Add the Apify MCP server with this Actor:

https://mcp.apify.com?tools=kr-data/korea-medical-device-approval

Source and license

식품의약품안전처_의료기기 품목허가 정보 (data.go.kr 15057456), 이용허락범위 제한 없음. Data is passed through unchanged except for English field names and labels, the pathway/origin/IVD labels read from the approval number, and date and business-number formatting.

More Korean data from KR Data

• Korea Drug & Medical Device Recalls — recent MFDS recalls and sales suspensions
• Korea HS Code Import Requirements — customs permits and certificates per HS code
• Korea Business Check (KYB) — business registration status, company profile, financials
• Korea Company Headcount — monthly National Pension headcount, hires and leavers
• Korea Online Seller Registration Check — mail-order business registration (통신판매업) by business number
• Korea Financial Company Lookup — Korean banks, brokers and insurers with IDs and audit opinion
• Korean Address to English — official English address and postal code
• Korean Law in English — official English text of Korean statutes
• Korea Flood-Damaged Car Check — flood-damage insurance records by license plate