KFDA (MFDS)

The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is South Korea's regulatory authority responsible for ensuring the safety, efficacy, and quality of medical devices marketed in South Korea. The agency oversees the entire lifecycle of medical devices from pre-market approval to post-market surveillance.

Agency background and history:

Name evolution:
- 1998-2013 - Korea Food and Drug Administration (KFDA)
- 2013-present - Ministry of Food and Drug Safety (MFDS)

The name change in 2013 elevated the agency from an administration under the Ministry of Health and Welfare to an independent ministry, reflecting increased responsibilities and authority over food and drug safety.

Headquarters: Cheongju, North Chungcheong Province
Seoul office: Located in Yangcheon-gu for stakeholder meetings
Website: www.mfds.go.kr (Korean), https://www.mfds.go.kr/eng/ (English)

MFDS organizational structure:

Medical Device Safety Bureau:
- Medical Device Policy Division
- Medical Device Management Division
- Medical Device Review Division
- Medical Device Post-Market Division

Regional offices:
Six regional MFDS offices throughout South Korea for inspections and enforcement.

Medical device classification system:

South Korea classifies medical devices into four risk-based classes similar to EU and other major markets:

Class I - Low risk:
- General medical devices
- Minimal potential for harm
- Examples: bandages, tongue depressors, examination gloves, simple patient monitors
- Regulatory pathway: Notification (simplified registration)

Class II - Low-to-moderate risk:
- Moderate potential for harm
- Examples: infusion pumps, blood pressure monitors, surgical instruments, contact lenses
- Regulatory pathway: Technical Document Review

Class III - Moderate-to-high risk:
- Higher potential for harm
- Examples: ventilators, defibrillators, bone plates, HIV test kits
- Regulatory pathway: Technical Document Review with Clinical Data

Class IV - High risk:
- Critical or life-sustaining devices
- Highest potential for harm
- Examples: pacemakers, heart valves, stents, drug-eluting devices, brain implants
- Regulatory pathway: Rigorous Technical Document Review with Extensive Clinical Data

Classification is determined by:
- Intended use and purpose
- Contact duration with body
- Invasiveness
- Active vs. passive device
- Body system/area affected

Medical device regulatory pathways:

1. Class I Notification (신고)
- Simplified procedure for low-risk devices
- Manufacturer submits notification documentation
- MFDS issues notification within 15-30 working days
- No clinical data typically required
- Quality management system certification required

2. Manufacturing License (제조업허가)
All manufacturers producing devices in South Korea must obtain:
- Manufacturing facility license from MFDS
- KGMP (Korean Good Manufacturing Practice) compliance
- Facility inspection before license issuance
- Periodic re-inspection every 3-5 years

3. Product Registration (품목허가/신고)

For Class II, III, IV devices:
- Submit technical documentation to MFDS
- Product-specific registration required for each device model
- Review timeline: 60-180 days depending on class and completeness
- Clinical data requirements increase with device class

Required documentation:
- Application form (MFDS standardized format)
- Device description and specifications
- Manufacturing process information
- Quality management system certification (ISO 13485 or KGMP)
- Biocompatibility testing per ISO 10993 (if applicable)
- Electrical safety and EMC testing per IEC standards (if applicable)
- Performance and safety testing data
- Clinical evaluation report or clinical trial data
- Labeling and instructions for use (Korean language required)
- Foreign marketing approval certificates (if applicable - FDA, CE, TGA, PMDA)

Korean Good Manufacturing Practice (KGMP):

KGMP requirements:
Similar to ISO 13485 but with Korea-specific elements:
- Quality management system documentation
- Design controls and development processes
- Production and process controls
- Corrective and preventive actions (CAPA)
- Complaint handling and adverse event reporting
- Internal audits and management reviews
- Supplier and contract manufacturer controls

KGMP certification:
- Issued by MFDS or designated certification bodies
- Valid for 3 years
- Re-certification required before expiration
- Surveillance audits may occur during validity period

For foreign manufacturers:
- ISO 13485 certification generally acceptable
- May still require KGMP inspection for high-risk devices
- Korean manufacturing site license if producing in Korea

Local representative requirements:

Korea Import License (수입업허가):
Foreign manufacturers must designate an importer/distributor with:
- Import business license from MFDS
- Legal entity registered in South Korea
- Qualified personnel with medical device knowledge
- Adequate storage facilities meeting KGMP requirements
- Quality management system in place

Responsibilities of Korean importer:
- Submit registration applications on behalf of foreign manufacturer
- Maintain technical documentation in Korea
- Handle adverse event reporting to MFDS
- Manage product recalls and field safety corrective actions
- Serve as contact point for MFDS communications
- Maintain import records and traceability
- Ensure labeling compliance with Korean regulations

Importer cannot be changed easily:
- Requires re-registration of medical device
- New importer must submit updated documentation
- MFDS review and approval required

Clinical trial and data requirements:

Clinical trials in Korea:
For Class III and IV devices, especially novel or high-risk devices:
- Clinical trial approval required from MFDS before starting
- Institutional Review Board (IRB) approval
- Good Clinical Practice (GCP) compliance
- Trial registration in Korean clinical trial database
- Qualified clinical investigators at approved sites

Clinical trial application contents:
- Investigator's brochure
- Clinical trial protocol
- Informed consent forms (Korean language)
- Device technical information
- Pre-clinical testing results
- Risk analysis and safety monitoring plan
- Statistical analysis plan
- Insurance for trial subjects

Clinical trial approval timeline: 30-60 days from complete submission

Foreign clinical data acceptance:
- Clinical data from FDA, CE, or other recognized jurisdictions may be acceptable
- MFDS may request additional Korean clinical data for ethnic differences
- Literature review and clinical evaluation reports considered
- Equivalence to predicate devices helps support clinical safety/efficacy

Post-market surveillance and vigilance:

Adverse event reporting:
Manufacturers and importers must report to MFDS:
- Death or serious injury: Report within 15 days of awareness
- Device malfunction with potential for harm: Report within 15 days
- Quarterly summary reports of all adverse events
- Annual safety update reports

Post-Market Surveillance (PMS) requirements:
- Class III and IV devices require PMS plans
- Collect real-world safety and performance data
- Review and update risk assessments
- Track complaints and trends
- Submit periodic PMS reports to MFDS

Field Safety Corrective Actions (FSCA):
If safety issue identified:
- Notify MFDS before implementing recall or corrective action
- Submit FSCA plan and timeline
- Issue safety notice to users and customers
- Report completion and effectiveness of corrective action
- MFDS may require mandatory recall if manufacturer does not act

Medical device reimbursement:

National Health Insurance (NHI):
South Korea has universal healthcare coverage through NHI:
- Medical devices used in healthcare facilities may be reimbursed
- Reimbursement codes and amounts set by NHI
- Separate application to Health Insurance Review and Assessment Service (HIRA)
- Not all approved devices receive reimbursement
- Price negotiation based on clinical value and cost-effectiveness

MFDS vs. HIRA:
- MFDS - Safety and efficacy approval (regulatory approval)
- HIRA - Reimbursement and pricing decisions (market access)
- Both approvals often needed for commercial success

Recent regulatory updates:

Medical Device Act amendments:
South Korea continuously updates regulations:
- Increased focus on software as medical device (SaMD) and AI devices
- Unique Device Identification (UDI) implementation (phased approach)
- Strengthened post-market surveillance requirements
- Enhanced cybersecurity requirements for connected devices
- Fast-track pathways for innovative medical devices

Innovative Medical Device Priority Review:
MFDS offers expedited review for:
- Devices addressing unmet medical needs
- Significantly improved clinical outcomes
- Novel technologies
- Orphan/rare disease devices
- Review timeline reduced by 30-50%

Unique Device Identification (UDI):
Phased implementation started in 2019:
- High-risk devices (Class III, IV) first
- Gradual rollout to lower-risk classes
- UDI labeling and database registration required
- Based on international standards (GS1, HIBCC)

Regulatory timelines:

Typical approval timelines from submission:
- Class I notification: 15-30 days
- Class II registration: 60-90 days
- Class III registration: 90-150 days
- Class IV registration: 120-180 days
- Clinical trial approval: 30-60 days

Timelines assume complete and adequate documentation. Deficiency questions or requests for additional data extend timelines.

Total time-to-market including preparation:
- Document preparation: 3-6 months
- Testing and clinical data: 6-12 months
- Regulatory review: 2-6 months
- Total: 12-24 months for new device registration

Comparison to other regulatory systems:

MFDS vs. FDA:
- Similar risk-based classification (4 classes)
- MFDS requires Korean language labeling and local representative
- FDA has 510(k) substantial equivalence pathway; Korea does not
- Both require clinical data for high-risk devices
- MFDS acceptance of foreign data depends on device risk

MFDS vs. EU MDR:
- Both use 4-tier classification systems
- MFDS centralized government review; EU uses Notified Bodies
- Korea requires product-specific registration; EU uses broader technical files
- Both emphasize post-market surveillance and vigilance

MFDS harmonization efforts:
South Korea participates in international harmonization:
- IMDRF (International Medical Device Regulators Forum) member
- Aligns standards with ISO, IEC international standards
- Mutual recognition discussions with other countries
- Accepts ISO 13485 certificates from accredited bodies

Common challenges for foreign manufacturers:

Korean language requirements:
- All labeling, instructions for use, and packaging must be in Korean
- Technical documentation can be in English with Korean summaries
- Clinical trial documents must be in Korean

Testing requirements:
- MFDS may require Korea-specific testing even with foreign approvals
- Electrical safety and EMC testing at Korean-approved labs sometimes required
- Biocompatibility testing to ISO 10993 from recognized labs acceptable

Importer dependency:
- Strong reliance on Korean importer for regulatory interactions
- Importer changes require re-registration (time and cost)
- Finding qualified, reliable importer crucial

Approval unpredictability:
- Review timelines can extend due to questions and requests
- Clinical data requirements not always clear upfront
- Reviewer discretion in requesting additional information

Best practices for MFDS registration:

Early planning:
- Engage Korean regulatory consultant or importer early
- Understand classification and applicable standards
- Plan testing and clinical data collection in advance

Thorough documentation:
- Provide comprehensive technical files upfront
- Anticipate potential questions and address proactively
- Ensure Korean translations are accurate and complete

Leverage foreign approvals:
- Submit FDA, CE, or other major market approvals as supporting evidence
- Provide regulatory correspondence and approval letters
- Cite acceptance of device in other markets

Choose importer carefully:
- Experienced importer with medical device expertise
- Strong relationships with MFDS and healthcare stakeholders
- Adequate resources for post-market responsibilities
- Alignment with company's commercial strategy

Post-approval management:
- Maintain communication with MFDS and importer
- Comply with adverse event reporting timelines
- Plan for periodic re-certification and renewals
- Monitor Korean regulatory changes affecting devices

South Korea is a significant medical device market with a robust and evolving regulatory system. MFDS emphasizes patient safety while supporting innovation, making Korea both challenging and rewarding for medical device manufacturers seeking Asian market access.