Approval Process of Medical Devices in South Korea (MFDS)

South Korea regulates medical devices under a hierarchy of rules that includes the Medical Device Act (MDA), its enforcement decree/regulations, and MFDS notifications that provide detailed technical requirements and operational procedures. ([MFDS][1])

Regulatory pathways at a glance

MFDS explains three main premarket pathways, depending on risk class:

• Class I: Notification
• Class II: Certification or Approval
• Class III & IV: Approval ([MFDS][1])

In principle, Class I & II devices are handled via certification by organizations such as MDITAC and NIDS, while Class III & IV devices are approved by MFDS. MFDS also notes that some Class I & II categories must be approved by MFDS (for example, where clinical test reports are required, digital healthcare-related products like telemedicine systems, undefined nomenclature/classification, or products combined with pharmaceuticals). ([MFDS][1])

Device classification (risk-based)

MFDS uses four classes (I–IV) based on potential risk to human health, harmonized with GHTF/IMDRF rules. ([MFDS][1]) The MFDS page also lists counts of recognized device/IVD items under the applicable product classification regulations. ([MFDS][1])

Technical documentation: what MFDS expects

MFDS requires submission of Technical Documents for certification/approval. ([MFDS][1]) These documents cover device quality, including performance and safety, and typically include information such as:

• intended use
• mechanism of action (MoA)
• operational/functional structure
• raw materials
• instructions for use
• test specifications ([MFDS][1])

Two review tracks: General review vs SER

MFDS describes two technical-document review tracks:

• General Technical Document Review: if a device is substantially equivalent to legally marketed devices, clinical trial reports are not required. ([MFDS][1])
• Safety and Efficacy Review (SER): the technical document including clinical trial reports is thoroughly reviewed. MFDS indicates clinical trial reports are required when differences (e.g., intended use, MoA, raw materials) could significantly affect safety and efficacy. ([MFDS][1])

Indicative timelines shown by MFDS

The MFDS overview diagram provides indicative review timelines, including:

• Certification (Class II): shown as 5 days
• Approval: shown as 10 days
• Technical document review: shown as 55 days
• Clinical report review: shown as 70 days ([MFDS][1])

MFDS also explains that NIDS is established under the Medical Device Act and is entrusted with tasks related to notification/certification, and that NIFDS (an affiliated agency) approves novel Class II devices and Class III & IV devices. ([MFDS][1])

Business licenses (manufacturing and import)

Separately from the product pathway, MFDS states that anyone intending to manufacture devices in Korea or import devices from overseas must obtain:

• a manufacturing business license, and/or
• an import business license ([MFDS][1])

MFDS notes:

• business license approval is handled by the regional office where the business site is located, and
• business license and product license processes are conducted contemporaneously because at least one product license is needed. ([MFDS][1]) MFDS also lists example document requirements (medical certificates, quality manager qualifications) and indicates a 25-day review for business license approval. ([MFDS][1])

Post-market: tracking and control (selected devices)

MFDS indicates that 52 device items are designated as subject to tracking and control because adverse events or defects could cause fatal harm, including implanted devices used for over one year and certain life-sustaining items used outside medical facilities. ([MFDS][1]) MFDS also outlines recordkeeping expectations for handlers (manufacturers/importers, distributors/lessors, repairers, users) to enable traceability. ([MFDS][1])

Q&A

What decides whether a device follows notification, certification, or approval?

MFDS bases the pathway on risk class: Class I uses notification, Class II uses certification or approval, and Class III/IV use approval. ([MFDS][1])

Who handles Class II certification, and who handles approvals?

MFDS explains that Class I & II are, in principle, certified through organizations such as MDITAC/NIDS, while approvals (especially Class III/IV) are under MFDS, and NIFDS (affiliated with MFDS) approves novel Class II and Class III/IV devices. ([MFDS][1])

What is the key difference between the general review and SER?

The distinguishing factor is whether clinical trial reports are mandatory:

• General review: substantial equivalence, no clinical trial reports required
• SER: clinical trial reports included and thoroughly reviewed ([MFDS][1])

When does MFDS say clinical trial reports are required?

MFDS indicates they are required when differences such as intended use, MoA, or raw materials could significantly affect safety and efficacy. ([MFDS][1])

What timelines does MFDS show for review?

MFDS’s overview diagram shows indicative durations such as 5 days (certification), 10 days (approval), 55 days (technical document review), and 70 days (clinical report review). ([MFDS][1])

Is a business license separate from a product license?

Yes. MFDS describes manufacturing/import business licenses and notes they are processed alongside the product license process (since at least one product license is needed). ([MFDS][1])

References (official)

• MFDS — Approval Process (Medical Devices) ([MFDS][1])