In line with recommendations from the Global Harmonization Task Force, the Singapore Health Sciences Authority (HSA) has implemented two new evaluation routes for Class C and Class D medical devices in Singapore as of January 1, 2013.
Previous Routes:
- Full Evaluation Route: required of devices not previously approved by any of HSA’s medical device reference agencies (US FDA, EU, Health Canada, Japan MHLW, and Australia TGA). The target turn-around time (TAT) for Full Evaluation for Class C devices is 220 working days. The target TAT for Full Evaluation of Class D devices is 310 working days.
- Abridged Evaluation Route: for devices with at least one reference agency’s approval. The target TAT for Abridged Evaluation for Class C devices is 160 working days. The target TAT for Abridged Evaluation for Class D devices is 220 working days.
New Routes:
- Expedited Class C Registration (ECR) – target TAT of 120 days.
- ECR – 1 : available for devices with
- At least one reference agency’s independent approval
- 3+ years of marketing in the independent reference agency’s jurisdiction
- No safety issues globally
- ECR – 2: Available for devices with at least two independent reference agencies’ approvals
- ECR – 1 : available for devices with
- Expedited Class D Registration (EDR) – target TAT of 180 days.
- Available for devices with at least two independent reference agencies’ approvals