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SaMD — MFDS Policy

MFDS has developed a comprehensive SaMD framework aligned with the IMDRF SaMD definition documents (N10 — definition and scope, N12 — lifecycle framework, N23 — validation of AI/ML), with guidance published in 2023.

Classification​

SaMD grade determined by:

  1. Significance of information provided (critical → serious → non-serious)
  2. Healthcare situation (critical → serious → non-serious)

Not regulated​

  • Administrative software (EHR scheduling, billing)
  • General wellness apps with no medical purpose
  • Simple communication tools

Predetermined Change Control Plan (PCCP)​

MFDS is developing PCCP guidance for AI/ML SaMD — allowing manufacturers to pre-define future algorithm changes that do not require a new submission.

Classification matrix ​ SaMD grade is determined by combining two dimensions: ​ • Significance of information: critical (treatment/diagnosis decisions) → serious (patient safety impacts) → non-serious (supportive information) • Healthcare situation: critical (life-threatening) → serious (serious illness) → non-serious (routine care) ​ Critical/critical combinations typically result in Grade III or IV; serious/serious in Grade II or III; non-serious/non-serious in Grade I or exempt.

AI/ML SaMD examples ​ Example use cases for PCCP: • Diagnostic imaging algorithms: pre-defined algorithm retraining based on validation datasets • Patient monitoring apps: predetermined updates to risk stratification models • Clinical decision support: pre-approved modifications to evidence-based scoring systems ​ PCCP is not applicable to fundamental algorithm changes in mechanism of action, new intended uses, or expansion to new patient populations, which require new submissions.

PCCP submission and approval

Manufacturers seeking PCCP approval must submit detailed documentation including: (1) algorithm design specifications and validation datasets; (2) pre-defined parameters for retraining (e.g., data sources, validation thresholds, performance acceptance criteria); (3) a monitoring and evaluation plan outlining how ongoing performance will be assessed; and (4) predefined change triggers and decision trees. MFDS review of PCCP submissions typically requires 6–12 months depending on complexity. Once approved, manufacturers may implement pre-defined changes without additional 품목허가 amendments, provided changes remain within the approved PCCP scope. Changes outside the PCCP scope require a new submission.