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Technical Documents

Overview​

Technical documents form the core of the CSDT dossier, demonstrating that the device is safe, effective, and conforms to applicable standards. The depth of documentation required scales with the device risk class.

Device Description and Specification​

Every dossier must include a comprehensive device description covering:

ElementContent
Device nameTrade name and generic name
Intended usePrecise description including indication, target patient population, user, and clinical setting
ContraindicationsConditions under which the device must not be used
Principle of operationHow the device achieves its intended function
Physical descriptionDimensions, weight, materials, components, accessories
VariantsTable of all variants (sizes, configurations) covered by the submission
Shelf lifeClaimed shelf life and stability data supporting it
SterilityWhether sterile as supplied; if so, sterilisation method and validation

Essential Principles Checklist​

The Essential Principles are the ASEAN equivalent of the EU MDR General Safety and Performance Requirements (GSPR). The dossier must include a checklist confirming compliance with each applicable principle, citing:

  • The applicable standard or test method
  • Test report reference (or justification for non-applicability)
  • Pass/fail result

Key Technical Evidence Areas​

Biocompatibility​

For devices in contact with the human body or its fluids:

  • ISO 10993 series evaluation required
  • Extent of testing depends on contact type, duration, and tissue type
  • For Class A devices with no direct patient contact, biocompatibility testing may not be required

Sterility and Sterilisation Validation​

For devices supplied sterile:

  • Validation of the sterilisation method (ISO 11135, ISO 11137, ISO 17665 as applicable)
  • Bioburden data
  • Sterility assurance level (SAL) demonstration
  • Packaging integrity testing

Electrical Safety​

For active (powered) devices:

  • IEC 60601 series compliance (general and particular standards)
  • EMC testing per IEC 61000 series
  • Test reports from accredited laboratories

Performance Testing​

Device-specific performance standards (e.g. ISO standards for the specific device type) with test reports confirming conformance.

Software (if applicable)​

  • Software life cycle documentation (IEC 62304)
  • Cybersecurity assessment for network-connected devices

Site Master File / Production Flow​

Kemenkes evaluators review the Site Master File (or equivalent production flow documentation) to understand:

  • Where the device is manufactured
  • Key manufacturing steps and critical processes
  • Quality control checkpoints

Ensure the manufacturing site described in the Site Master File matches exactly with the name and address on the ISO 13485 certificate and GMP certificate.