Singapore Medical Device Registration
Health Sciences Authority (HSA) approval timelines and requirements
Singapore Medical Device Registration Overview
Singapore medical device registration through HSA typically takes 1-2 weeks for Class A devices. The official HSA target is 1 week, but realistic timelines include preparation, documentation review, and potential questions from regulators.Singapore uses a 4-class (A, B, C, D) risk-based classification system. Foreign manufacturers must appoint a Singapore Product Registrant to register devices in Singapore. HSA accepts MDSAP certification, which accepted for qms evidence. Registration is valid for No expiry (ongoing compliance required).
Singapore uses a 4-class (A, B, C, D) risk-based classification system.
Class A
Notification
• Notification only, no review
Class B
IBR/Expedited/Full Route
Accelerated with: FDA + EU (IBR = instant), FDA or EU (Expedited)
• IBR with 2+ reference approvals: <1 hour registration
Class C
IBR/Expedited/Full Route
Accelerated with: FDA + EU (IBR = instant), FDA or EU (Expedited)
• IBR route extremely fast with multiple approvals
Class D
IBR/Expedited/Full Route
Accelerated with: FDA + EU (IBR = instant), FDA or EU (Expedited)
• IBR with 3+ years marketed = instant
Immediate Registration (IBR)
Instant registration with 2+ reference country approvals (3+ years marketed)
Expedited Route
Fast-track with 1 reference country approval
Existing approvals from other regulatory authorities can accelerate your Singapore registration.
- Singapore Product Registrant (for foreign manufacturers)
- PRISM registration
- English labeling (no translation required)
No expiry (ongoing compliance required)
Accepted for QMS evidence
Singapore Medical Device Registration Process
Step-by-step HSA registration process. Total estimated timeline: 1-2 weeks.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by HSA. Appoint a Singapore Product Registrant.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to HSA including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksHSA reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
1 weekIn-depth technical assessment of device safety and performance. HSA may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, HSA issues Singapore market authorization certificate.
Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.