Class B Registration Guides
Available routes for Class B
Class B medical devices (low-to-medium risk) can be registered via three evaluation routes:
| Route | Conditions |
|---|---|
| Full | No prior approval from any overseas reference agency |
| Abridged | Approval from ≥1 overseas reference agency |
| Immediate (IBR) | Approval from ≥1 reference agency + 3 years marketing, or ≥2 approvals |
See Evaluation Routes for the full conditions for each route.
HSA registration guides for Class B
HSA publishes detailed guides for each Class B route specifying the required documents, format requirements, and submission checklist:
- Class B Full Registration Guide
- Class B Abridged Registration Guide
- Class B Immediate Registration (IBR) Guide
Always use the current version of the guide published on the HSA website. Do not rely on cached or previously downloaded versions, as HSA updates its guides when requirements change.
Typical documentation requirements
While exact requirements are specified in the registration guides, Class B applications typically require:
For Full and Abridged routes:
- Device description and specification
- Intended purpose statement
- Classification justification
- Manufacturing information (site details, QMS evidence)
- Risk management summary (ISO 14971)
- Design verification and validation evidence
- Clinical evidence (where applicable)
- Labelling (draft or final)
- Declaration of conformity (where applicable)
For Immediate (IBR) route:
- Evidence of qualifying overseas approval(s)
- Safe marketing history evidence (for IBR Condition 1)
- Device description and labelling
- Significantly reduced technical documentation compared to Full