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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: ​ â€ĸ Supplier qualification procedures â€ĸ Specifications and acceptance criteria â€ĸ Receiving inspection protocols â€ĸ Change control procedures for supplier substitutions ​ For Grade III/IV devices, supplier audits and stability data may be required.