Clinical Data Requirements for MFDS Medical Device Approval in South Korea
South Korea’s medical device regulatory system, governed by the Ministry of Food and Drug Safety (MFDS), places strong emphasis on clinical evidence to demonstrate safety and efficacy.
However, clinical data is not always required for every device.
Understanding when clinical trials are mandatory, what type of clinical evidence is acceptable, and how MFDS evaluates data is critical for successful market entry.
This guide explains the complete MFDS clinical data requirements for medical devices in South Korea, based on official regulatory frameworks.
What Are MFDS Clinical Data Requirements?
MFDS requires clinical data as part of the technical documentation submission, particularly under the Safety and Efficacy Review (SER) pathway.
Clinical data is included in supplementary evidence, alongside performance testing, risk analysis, and safety data.
👉 The key purpose:
Demonstrate clinical safety
Prove device performance in real-world use
Support benefit-risk evaluation
When Is Clinical Data Required by MFDS?
This is the most important ranking section (decision-based content)
1. Based on Device Classification
Device Class | Clinical Data Requirement |
Class I | Not required |
Class II | Required only if no equivalence |
Class III | Usually required |
Class IV | Mandatory |
👉 High-risk devices (Class III & IV) typically require clinical trial data to prove safety and effectiveness.
2. Based on Device Novelty
MFDS requires clinical data when there are significant differences in:
Intended use
Mechanism of action
Raw materials
Performance characteristics
If these differences impact safety or efficacy → clinical trial reports are required.
3. Safety and Efficacy Review (SER) Pathway
Clinical data is mandatory under SER
Used for:
Novel devices
High-risk devices
Devices without predicate equivalence
👉 In contrast:
General Technical File Review → No clinical data required
Types of Clinical Evidence Accepted by MFDS
MFDS allows multiple forms of clinical evidence, not just local trials:
1. Clinical Trial Data (Highest Level Evidence)
Required for:
New Class III & IV devices
Innovative or high-risk devices
Requirements:
Conducted at MFDS-approved clinical trial centers
Must follow Good Clinical Practice (GCP)
Requires MFDS approval before initiation
2. Foreign Clinical Data
MFDS may accept clinical data from:
US (FDA)
EU (CE-marked devices)
Japan, Canada, OECD countries
👉 Conditions:
Must meet international standards (e.g., ISO 14155)
May require additional Korean population data
3. Clinical Literature & Published Studies
Accepted when:
Device is equivalent to existing products
Supported by peer-reviewed scientific literature
👉 Common for:
Class I & II devices
Devices with established clinical history
4. Clinical Evaluation (Equivalence-Based)
Manufacturers can avoid trials if they demonstrate:
Substantial equivalence to predicate device
Comparable safety and performance
👉 Requires:
Detailed comparison table
Scientific justification
5. Real-World Evidence (RWE) – Emerging Trend
MFDS increasingly accepts:
Post-market data
Patient registries
Long-term follow-up data
👉 Especially for:
Implantable devices
High-risk technologies
Clinical Trial Requirements in South Korea
If clinical trials are required, the sponsor must submit:
Clinical trial protocol
Investigator’s brochure
Risk analysis & safety monitoring plan
Informed consent forms (Korean)
Preclinical data
Statistical analysis plan
👉 Trials must be conducted at MFDS-designated institutions
👉 Approval timeline:
Typically 30–60 days
Key Factors MFDS Uses to Evaluate Clinical Data
MFDS assesses clinical evidence based on:
Safety outcomes
Clinical performance
Risk-benefit profile
Comparison with predicate devices
Study design and statistical validity
👉 The agency may request additional data if evidence is insufficient.
Common Mistakes to Avoid
🚫 Submitting insufficient equivalence justification
🚫 Using foreign data without localization strategy
🚫 Ignoring MFDS-specific formatting (Korean language requirement)
🚫 Lack of GCP compliance in trials
🚫 Missing clinical evaluation report (CER)
Pro Tips to Get Faster MFDS Approval
✔ Use equivalence route when possible
✔ Request pre-submission consultation with MFDS
✔ Align clinical data with SER expectations early
✔ Combine literature + real-world evidence strategically
Conclusion
Clinical data requirements for MFDS medical device approval depend on device classification, novelty, and risk level.
Low-risk devices → No clinical data
Equivalent devices → Literature or existing data
High-risk/novel devices → Clinical trials required
Understanding this decision pathway helps manufacturers:
Reduce regulatory delays
Avoid unnecessary trials
Optimize approval strategy in South Korea
