Technical Documentation
Technical documentation for MDACS listing must demonstrate compliance with the Essential Principles of Safety and Performance (TR-001).
Core Dossier Elements
| Document | Purpose |
|---|---|
| Device description | Name, model, materials, intended use, principle of operation |
| Essential principles checklist | Maps TR-001 requirements to compliance evidence |
| Risk management file | ISO 14971 process — hazard identification, risk controls, residual risk |
| Clinical/performance evaluation | Clinical evidence of safety and performance |
| QMS certificate | ISO 13485 from accredited certification body |
| Labelling and IFU | Proposed HK labelling (bilingual for home-use devices) |
| Manufacturing site / GMP evidence | GMP certificate or ISO 13485 site certification |
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
| Class | Key Requirements |
|---|---|
| II | ISO 13485; conformity evidence from recognised CB/NB |
| III | Class II + full clinical evaluation; design documentation |
| IV | Class III + comprehensive clinical data; often aligned with reference-country PMA/CE dossier |
| IVD B/C/D | Performance evaluation: sensitivity, specificity, precision, reference method comparisons |