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Technical Documentation

Technical documentation for MDACS listing must demonstrate compliance with the Essential Principles of Safety and Performance (TR-001).

Core Dossier Elements​

Labelling and IFU Proposed HK labelling in English and Chinese; bilingual IFU required for home-use and OTC devices

Essential Principles (TR-001)​

TR-001 covers:

  • General safety and performance requirements
  • Design and construction requirements (chemical, physical, biological properties)
  • Infection and microbial contamination controls
  • Environmental properties
  • Requirements for active devices and measuring functions
  • Protection against radiation

Documentation Depth by Class​

ClassKey Requirements
IIISO 13485; conformity evidence from recognised CB/NB
IIIClass II + full clinical evaluation; design documentation
IVClass III + comprehensive clinical data; often aligned with reference-country PMA/CE dossier
IVD B/C/DPerformance evaluation: sensitivity, specificity, precision, reference method comparisons

Revise the 'Labelling and IFU' row to read: 'Labelling and IFU: Proposed HK labelling in both English and Chinese for all devices; bilingual IFU mandatory for home-use devices and OTC products.'