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Design and Manufacturing Information

Required content​

  • Manufacturing sites — names, addresses, scope of activities
  • Manufacturing process — key steps, critical control points
  • Critical components and raw materials — specifications
  • Sterilisation — method and validation summary (for sterile devices)
  • Environmental controls — cleanroom classification where relevant
  • Incoming QC — for critical components

KGMP alignment​

Manufacturing information in the STED must be consistent with the KGMP certificate scope. Discrepancies identified during MFDS review will trigger clarification requests.

Critical components definition ​ Critical components are those whose failure or defect could affect device safety or performance. These must be identified through risk analysis (ISO 14971) and documented with: ​ • Supplier qualification procedures • Specifications and acceptance criteria • Receiving inspection protocols • Change control procedures for supplier substitutions ​ For Grade III/IV devices, supplier audits and stability data may be required.

Change control and post-approval manufacturing changes

Manufacturing changes after 품목허가 approval must follow a documented change control procedure and may require MFDS notification or approval. Notifiable changes include: (1) changes to manufacturing location, equipment, or process parameters affecting product quality or safety; (2) supplier substitutions for critical components; (3) changes to sterilisation method or parameters; and (4) material substitutions. Minor changes (e.g., equipment upgrade with equivalent validation, non-critical vendor changes) may be documented internally but must be reviewed during routine GMP inspections. Major changes typically require prior notification to MFDS or formal approval depending on risk class. Documentation of all changes, validation studies, and risk assessments must be maintained in the quality system.