Performance and Function Testing

Technical documentation must demonstrate the device performs as intended:

• Bench testing — mechanical, physical, functional performance
• Analytical performance (IVDs) — accuracy, precision, linearity, reference range
• Biocompatibility (ISO 10993 series)
• Shelf life / stability — real-time or accelerated aging
• Sterilisation validation (for sterile devices)
• Software verification and validation (for software components)
• Usability testing — human factors, especially for lay users

Test reports from MFDS-recognised testing laboratories required for standards-mandated tests.

Clinical performance testing — human clinical data, comparative effectiveness, safety outcomes in intended use population

Clinical performance testing requirements vary by device grade and risk level. For Grade III/IV devices, MFDS typically requires clinical data demonstrating safety and efficacy in the intended patient population. Clinical trials must comply with Good Clinical Practice (GCP) guidelines and be conducted under an approved clinical trial protocol. For lower-risk devices, real-world evidence or published literature may be acceptable depending on device type and predicate device availability.