Singapore HSA(Health Sciences Authority) applies Review Fee Increase Effective July 1, 2024. With effect from 1 July 2024, a fee increase averaging 5% will be implemented, with a minimum increase of $1 and capped at $200 per fee item.
The increased medical device fees are briefly as follows.
1. Medical Device Registration
| Product registration and evaluation fee | Class B | Class C | Class D | Class D with a registrable drug |
| Application fee | $560 | $560 | $560 | $560 |
| Immediate route fee | $1,000 | $3,340 | - | - |
| Expedited route fee | - | $3,340 | $5,930 | - |
| Abridged route fee | $2,010 | $3,900 | $6,250 | $10,600 |
| Full route fee | $3,900 | $6,250 | $12,000 | $75,600 |
| Full route (Priority Review Scheme* Route 1) |
$4,420 | $7,000 | $13,600 | - |
| Full route (Priority Review Scheme* Route 2) |
$5,660 | $9,000 | $17,500 | - |
2. Annual retention fees for medical devices Listed on Singapore Medical Devices Register (SMDR)
- Class B: $39
- Class C: $67
- Class D: $134
- Class D with a registrable drug: $134
Please refer to the attached file below for more information.
If you have any questions about medical device,
Please contact us with the below.
info@jnmglobal.net
ra@jnmglobal.net