Class C Registration Guides
Available routes for Class C
| Route | Conditions |
|---|---|
| Full | No prior approval from any overseas reference agency |
| Abridged | Approval from ≥1 overseas reference agency |
| ECR-1 | ≥1 approval + ≥3 years safe marketing + no safety issues + no prior rejection |
| ECR-2 | ≥2 approvals + no prior rejection/withdrawal |
ECR exclusion: Hip, knee, and shoulder joint replacement non-bioactive implants cannot use ECR — Full or Abridged only.
HSA registration guides for Class C
- Class C Full Registration Guide
- Class C Abridged Registration Guide
- Class C Expedited Registration (ECR) Guide
- Class C Immediate Registration Guide
Official sources
ECR-1: Available when the device has ≥1 approval from a reference agency, ≥3 years of safe marketing history, no known safety issues, and no prior rejection by HSA or the reference agency. ECR-2: Available when the device has ≥2 approvals from different reference agencies and no prior rejection or withdrawal by HSA or any reference agency.
The Immediate route is available for Class C devices that meet specific criteria including approval from overseas reference agencies and safe marketing history. Refer to HSA guidance for detailed eligibility conditions.