Korea’s medical device legislation has evolved from “drugs and devices together” to dedicated laws:
Practical impact:
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General active/non-active devices (Class I–IV) → Medical Devices Act -
IVD reagents/equipment (Class I–IV) → In Vitro Diagnostic Medical Devices Act -
Innovative medical devices → can apply for “innovative medical device designation” for acceleration -
Digital therapeutics, AI diagnostic software → Digital Medical Products Act from 2025
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Class I (low risk, e.g. masks, thermometers)
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Class II (moderate risk, e.g. ultrasound, monitors)
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Class III / IV (high/highest risk, e.g. stents, pacemakers)
For substantially equivalent Class II devices, Korea uses an efficient two-stage process:
Stage 1: technical documentation review by a third-party body (KTL/KTR, etc.)
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Submit the review request: technical documents include product performance reports, substantial equivalence comparison data, risk management report, biocompatibility/electrical safety test reports, etc. -
Review + deficiency response: the third party reviews comprehensively and requests additional information where needed. -
Issue of a Letter of Conformity: committed within 25 days (excluding time for deficiency responses).
Stage 2: NIDS certification
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Submit the certification application: with the Letter of Conformity and administrative documents (Korean labeling, IFU, Korean authorized agent information, etc.). -
Administrative review + deficiency response: NIDS only conducts a formal review, without repeating the technical review. -
Issue of the registration certificate: committed within 5 days (excluding time for deficiency responses)
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Review Request: submit a technical documentation review request to MFDS. -
Application: submit the formal application via the NIDS system. -
Review: MFDS review, possibly with requests for additional information.
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Classification and designation -
Approval/certification/notification/evaluation -
Digital medical device GMP (QMS) -
Approval and management of clinical trial protocols -
Cybersecurity -
Certification criteria for an excellent governance system
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Guideline on authorization review of digital medical device software (new) -
Guideline on clinical trial design for AI-based digital medical devices (revised) -
Guideline on authorization review of medical device software (revised) -
Guideline on authorization review of AI-based digital medical devices (revised) -
Guideline on authorization review of digital medical devices using virtual/extended reality technology (revised) -
Guideline on authorization review of digital therapeutics (revised)
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Determine the product classification in advance: check the MFDS Regulation on Medical Device Items and Classes by Item to confirm the risk class. -
Choose the right route
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With an equivalent product → NIDS certification (2–4 months)
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Innovative/digital products → prepare clinical/algorithm data and go through MFDS approval (4–12 months)
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Strengthened post-market surveillance: long-term follow-up requirements for implantable medical devices, effective 31 January 2025. -
Joint KGMP and MDSAP audits, 7 April 2025. Change: KGMP and MDSAP were previously audited separately; joint audits are now offered to foreign manufacturers, reducing the audit burden. -
Handling of sensitive information and collection of real-world data (RWD). Effective 1 August 2025. Content: provides a legal basis for post-market surveillance, allowing collection and analysis of real-world data.
The Korean medical device market has clear entry requirements and mature regulation, making it a high-quality overseas market worth long-term investment. For companies planning to expand globally, mastering the essentials of MFDS registration, the KGMP system and digital health compliance in advance prepares them well for going overseas.
EVERBIZ is well established in Vietnam, Singapore, Thailand, Malaysia, Germany, Austria and other major markets, providing medical device companies with one-stop overseas registration, compliance coaching and market access services. With mature local resources and professional experience, we have helped many Chinese device products enter overseas markets.