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

• HSA: Class C registration guides
• HSA: Fees and turnaround time