Medical Device Marketing Compliance Skill

Purpose

Evaluate whether medical device marketing activities comply with the KMDIA Fair Competition Code (의료기기 거래에 관한 공정경쟁규약). This is a pure analysis unit that receives activity descriptions and returns structured compliance judgments.

Input: Marketing activity description, activity type, involved parties Output: Compliance judgment (Permitted/Not permitted/Conditional/Case-by-case), applicable articles, rationale, related precedents Knowledge Base Date: 2024-07

Assessment Workflow

Mode 1: Q&A Compliance Judgment

When a user asks whether a specific activity is permitted:

1. •Identify the activity type and map to the relevant regulation article
2. •Read the matching reference file section for detailed rules
3. •Check the "Committee Guidance (2024 revision)" subsections in references/activity-guide.md for interpretive guidance
4. •Check "Violation Cases and Precedents" section in references/faq.md for similar past cases
5. •Apply the decision framework below
6. •Provide judgment with article citation, rationale, and relevant precedent cases

Mode 2: Activity Review Report

When a user submits a marketing plan or activity for comprehensive review:

1. •Read the full activity description
2. •Map each element to relevant regulation articles
3. •Read references/activity-guide.md for thresholds, checklists, and Committee interpretive guidance
4. •Cross-reference with "Violation Cases and Precedents" in references/faq.md for risk patterns
5. •Generate structured compliance report (see Report Template below)

Article Index by Activity Type

Decision Framework

Apply this 4-step framework for every compliance question:

Step 1: Subject Classification

Determine who is involved:

• •Healthcare professional (보건의료인): Regulated under the Code
• •Medical institution (의료기관): Regulated under the Code
• •Non-HCP hospital staff (코디네이터, 구매과 등): Generally NOT covered, but indirect provision rules may apply
• •Foreign HCP (해외 보건의료인): NOT covered unless affiliated with a domestic institution
• •Special relationships (가족, 친인척): Treated as provision to the HCP/institution

Step 2: Activity Mapping

Map the activity to a specific article. If the activity does not fall under Articles 6-17, it defaults to the general prohibition under Article 5 (restriction on provision of economic benefits).

Step 3: Threshold Check

Read references/activity-guide.md for:

• •Monetary limits (금액 한도)
• •Frequency limits (횟수 제한)
• •Prior approval requirements (사전심의/신고)
• •Documentation requirements (증빙서류)

Step 3.5: Committee Guidance and Precedent Check

Check "Committee Guidance (2024 revision)" subsections in references/activity-guide.md for:

• •Committee interpretive guidance on the relevant article
• •Specific procedural rules beyond the Code text (e.g., simple change exemption table, presenter limits)
• •Additional restrictions or exemptions from internal rules

Check "Violation Cases and Precedents" section in references/faq.md for:

• •Similar past violation cases and outcomes
• •Common pitfalls and enforcement patterns
• •Practical risk factors to flag

Step 4: Judgment

Provide one of these verdicts:

• •Permitted (허용): Clearly within regulation scope with specific article reference
• •Not permitted (불가): Explicitly prohibited or not covered by any exception
• •Case-by-case review required (사안별 개별 검토 요함): Depends on specific circumstances
• •Conditionally permitted (조건부 허용): Permitted if specific conditions are met

Response Format

Q&A Response

## Judgment: [Permitted/Not permitted/Case-by-case/Conditional]

### Applicable Regulation
- Code Article: [number and title]
- Operating Standard Article: [number and title]

### Rationale
[Explanation based on regulation text]

### Key Conditions (if applicable)
- [condition 1]
- [condition 2]

### Committee Guidance (if applicable)
- [relevant interpretive rule from activity-guide.md Committee Guidance sections]

### Related Violation Cases (if applicable)
- Case [letter-number]: [brief summary from faq.md Violation Cases section]

### Related FAQ
- FAQ #[number]: [brief summary if a matching FAQ exists]

Activity Review Report

## Compliance Review Report

### Activity Summary
[Brief description of the marketing activity]

### Compliance Assessment

| Item | Article | Verdict | Notes |
|------|---------|---------|-------|
| [item 1] | Art. X | OK/NG/Review | [detail] |
| [item 2] | Art. Y | OK/NG/Review | [detail] |

### Risk Areas (cross-referenced with faq.md Violation Cases)
1. [risk description, similar violation case reference, and mitigation]

### Required Procedures
- [ ] Prior approval (사전심의)
- [ ] Post-report (사후신고)
- [ ] Documentation (증빙서류)

### Recommendation
[Overall assessment and recommended actions]

Key Principles

These overarching principles from Article 2 (Basic Principles) apply to ALL activities:

1. •Marketing activities must be within the scope of fair trade law and accepted business customs
2. •Scientific/educational information delivery must NOT compromise HCP independence in device selection
3. •Activities must take place at appropriate venues matching their purpose
4. •All financial records must be accurate, transparent, and properly documented

References

• •references/regulation.md - Full text of the Fair Competition Code and Operating Standards (2017.11.10 base), organized by chapter and article
• •references/activity-guide.md - Activity-by-activity compliance checklist with monetary limits, frequency limits, procedural requirements, AND "Committee Guidance (2024 revision)" subsections containing the latest KMDIA Review Committee interpretive rules (2024.07.12 revision integrated inline)
• •references/faq.md - 70+ official FAQ items from KMDIA 2022 organized by article, PLUS "Violation Cases and Precedents" section with real warning actions and enforcement patterns (2023.05.02 cases integrated, duplicates with existing FAQ removed)

Disclaimer

This skill provides AI-generated reference information only and does not constitute regulatory advice, legal guidance, or official regulatory determination. All compliance decisions must be validated by qualified regulatory affairs professionals.