HSA announces fee increase for Health Products
Singapore, 2 July 2024 – The Health Sciences Authority (HSA) is responsible for regulating health products to ensure they meet the required standards of quality, safety, and efficacy. To support this mission, various fees are in place for the registration, licensing, notification, and permit issuance for therapeutic products, medical devices, Chinese proprietary medicines, cosmetic products, cell tissue and gene therapy products, oral dental gums, and retail pharmacies.
Effective from 1 July 2024, HSA will implement a fee increase averaging 5%. The adjustment will feature a minimum increase of $1 and will be capped at $200 per fee item. This fee revision is deemed necessary to recover part of the costs associated with the services provided to businesses.
For a comprehensive list of the updated fees, please refer to the following link: HSA Fee Changes.
NEW HSA GOVERNMENT REVIEW FEES IN SINGAPORE
| REGISTRATION ROUTE | CLASS B | CLASS C | CLASS D | CLASS D W REGISTRABLE DRUG |
|---|---|---|---|---|
| Application Fee | $560 | $560 | $560 | $560 |
| Immediate Route Fee | $1,000 | $3,340 | N/A | N/A |
| 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 | N/A |
| Full Route (Priority Review Scheme* Route 2) | $5,660 | $9,000 | $17,500 | N/A |
NEW CHANGE NOTIFICATION REVIEW FEES IN SINGAPORE
The updated change notification fees are as follows:
| CHANGE NOTIFICATION TYPE | CLASS B | CLASS C | CLASS D (INCLUDING DEVICES WITH A REGISTRABLE DRUG) |
|---|---|---|---|
| Administrative Changes | $560 | $560 | $560 |
| Technical Changes | N/A | $1,890 | $3,120 |
| Review Changes | $560 | N/A | N/A |
NEW RETENTION FEES IN SINGAPORE
Singapore’s Health Science Authority requires license holder pay an annual retention fees to maintain the SMDR listing and has also slightly increased these fees.
| DEVICE CLASSIFICATION | OLD FEES | REVISED FEES (EFFECTIVE JUST 1ST, 2024) |
|---|---|---|
| Class B | $37 | $39 |
| Class C | $64 | $67 |
| Class D | $128 | $134 |
| Class D w Registrable Drug | $128 | $134 |
