How do you determine Class I, IIa, IIb or III?

Author:Sonictec · 2026-09-11 Updated

Intended use is the starting point for classification

Common non-IVD classes include I, IIa, IIb and III. Manufacturers determine classification from intended use and applicable rules with a reasonable rationale. Terms such as monitoring equipment or surgical instrument are insufficient on their own.

Key questions to check

Assessment generally considers whether a device is active or invasive, contact location and duration, and its influence on diagnosis or treatment. More than one rule may apply, and some products have specific provisions. Assess the actual rules together.

Similar products may have different classifications

Similar appearance, materials or technology may lead to different assessments because of use methods, intended purposes or risks. Competitor products or overseas classifications cannot replace an Australian classification rationale.

Check IVDs and medical software separately

IVDs use a separate Class 1 to Class 4 system. For medical software, first establish whether it is a regulated medical device and whether any exclusion or exemption applies, then assess requirements against its intended use and influence on clinical decisions.

Why classification affects project planning

Classification affects evidence, assessment and application requirements. Establishing the rationale early helps plan documentation and budget and reduces time spent on unsuitable pathways.

Provide product information that supports assessment

Prepare intended use, instructions, use settings, operating principle, model differences and existing authorizations. Sonictec can discuss classification questions and registration preparation on that basis; final assessment requires complete information and applicable rules.