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Medical Devices

HomeComplianceMedical Devices
Example of a medical device: an MRI scanner in a hospital imaging roomApproval for every product, a Standard Pre-Clearance Report for every shipment

Anyone who imports medical devices or in vitro diagnostic (IVD) medical devices must obtain approval (including certification or notification) from the Minister of Food and Drug Safety (MFDS) for each product. Each shipment may be imported and cleared only after a Standard Pre-Clearance Report (pyojun tonggwan yejeong bogo) has been filed by electronic data interchange (XML) with the head of the requirement-verification body designated and announced by the Minister.

Importer Eligibility

Medical devices and IVD devices

Who may import

  • Medical device importers
  • IVD medical device importers
  • Medical device manufacturers — only if they hold manufacturing product approval (certification or notification) for a product that is imported in functional form and then goes through additional processes such as packaging, sterilization, or cutting
  • IVD medical device manufacturers — only if they hold manufacturing product approval (certification or notification) for a product that is imported in functional form as an IVD device and then goes through additional processes such as packaging, sterilization, or cutting

Any commissioning party (wituakja) must also be one of the four above and must be the same as the importer.

First and repeat imports

Required documents

  • Copy of the import product approval certificate or manufacturing product approval certificate for the goods
  • Products that contain or use materials derived from ruminants such as cattle, sheep, or goats also require one copy of the documents specified in Article 35(12) of the Consolidated Public Notice on Import and Export (Tonghap Gonggo)

Medical Device Import Process

Sent by importerReceived by importer

ImporterAgency
  1. 01
    Class 1 Import notificationNational Institute of Medical Device Safety Information
    Class 2 Import certification applicationNational Institute of Medical Device Safety Information
    Class 3–4 Import approval applicationMinistry of Food and Drug Safety (MFDS)
    Importer license applicationRegional Office of Food and Drug Safety
  2. 02
    OrderManufacturer in exporting country
    Devices arrive at customsManufacturer in exporting country
  3. 03
    Standard Pre-Clearance Report filedKorea Medical Devices Industry Association (KMDIA)
    Pre-Clearance Report receiptKorea Medical Devices Industry Association (KMDIA)
  4. 04
    Import declarationKorea Customs Service
    Import declaration certificateKorea Customs Service
  5. 05
    Cleared and importedImporter

Information Exchanged Between Agencies

  • Ministry of Food and Drug SafetyImporter license and import certification (notification) dataKorea Medical Devices Industry Association
  • Korea Medical Devices Industry AssociationSends Pre-Clearance Report resultsKorea Customs Service and importer
  • Korea Customs ServiceClearance results noticeKorea Medical Devices Industry Association
  • Korea Medical Devices Industry AssociationConsolidated import performance report (annual)Ministry of Food and Drug Safety

Standard Pre-Clearance Report Process

  1. Open a new e-document account
    • Apply to the Korea Customs Service and an ASP service provider
  2. Document review and new company registration (first time only)
    • Business registration certificate
    • Medical device importer license
    • Product DB

    Note: When importing devices for testing or clinical trials without an importer license, submit only the business registration certificate.

  3. Account activated
    • Product DB sent to the importer with notice that the account is active
  4. Product DB review (skipped for fewer than 10 models)
    • Check that the product DB matches the import approval or certification (notification) certificate

      Note: Submit only when registering 10 or more new model names.

    • Upload the reviewed product DB to the association's system
  5. Standard Pre-Clearance Report filed
    • Transmit as an electronic document (XML) through the Korea Customs Service or an ASP service provider website
  6. Standard Pre-Clearance Report review
    • Review of import approval or certification (notification) details
      - Check that the received product details match the association DB
      - Cross-check with the MFDS product register (collaboration system)
    • Check and review documents such as confirmations for test-use medical devices and clinical trial plan approvals
    • Processing time (business hours)
      - Within 8 hours of receipt
      - Within 3 days for filings with BSE documents
      - For filings resubmitted after a correction or error notice, within 8 hours of resubmission
    Items Subject to Stricter Import Checks
    • BSE (TSE) matters
    • Non-precious dental alloys
    • Imports of breast pump products
    • Medical devices made with raw materials that raise safety or efficacy concerns — mercury (except dental use), IV sets containing DEHP, DBP, or BBP, powdered gloves, asbestos, etc.
  7. Approval or error notice
  8. Pre-Clearance Report receipt (approval document)
    • Approval document sent to the Korea Customs Service and the importer
  9. Electronic tax invoice issued
    • Tax invoice issued for Standard Pre-Clearance Reports (once a month)

Tell us the class of the medical device you plan to import and whether it already has product approval, and we will walk you through the approvals you need and the Standard Pre-Clearance Report process.

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Laws and requirements as of October 26, 2026