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July 16, 2025
Approximately 5 minutes
IVD Device Registration in Singapore: HSA's Risk-Based Reliance Pathways
IVD Device Registration in Singapore: HSA's Risk-Based Reliance Pathways
The registration and approval of In Vitro Diagnostic (IVD) devices in Singapore are overseen by the Health Sciences Authority (HSA). The process is known for being transparent and highly reliant on prior approvals in major regulatory jurisdictions, referred to as Reference Countries. All applications must be managed and submitted by a local entity that holds the license, known as the Registrant.
Classification and Basic Requirements
- Classification: HSA follows the Global Harmonization Task Force (GHTF) guidelines, classifying IVD devices into four risk classes: Class A (lowest risk) to Class D (highest risk).
- Class A IVDs: General Class A IVD devices do not require pre-market registration but must be listed with the HSA annually by the licensed importer. Sterile Class A IVDs, however, must be registered (Fee: S$25; Processing Time: 30 working days).
IVD Registration Pathways, Timelines, and Fees
The registration route for Class B, C, and D IVD devices is determined by the device's classification and its approval history in Reference Countries, which significantly impacts the processing time and fees.
| Class | Pathway | Reference Country Criteria | Review Time | Fee (S$) |
|---|---|---|---|---|
| B | Immediate (IBR) | 2 approvals, each > 3 years without safety concerns | 0 working days | S$1,400 |
| B | Expedited (EBR) | 2 approvals OR 1 approval > 3 years without safety concerns | 60 working days | S$1,400 |
| B | Abridged | 1 approval | 100 working days | S$2,300 |
| B | Full | None | 160 working days | S$4,000 |
| C | Expedited (ECR) | 2 approvals OR 1 approval > 3 years without safety concerns | 120 working days | S$3,500 |
| C | Abridged | 1 approval | 160 working days | S$4,000 |
| C | Full | None | 220 working days | S$6,200 |
| D | Expedited | 2 approvals OR 1 approval > 3 years without safety concerns | 180 working days | S$6,100 |
| D | Abridged | 1 approval | 220 working days | S$6,300 |
| D | Full | None | 310 working days | S$11,900 |
Note: All fees listed are application and evaluation fees. An additional one-time application fee of S$560 applies to all Class B, C, and D registrations.
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