“The new fees going into effect this month have an increase of 5% across the board.”
Kenna Rasiklal
Principal Consultant
Asia Actual Singapore
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Singapore’s HSA Increases Medical Device Registration Fees
Published on: July 2nd, 2024
Starting July 1st, 2024, Singapore’s Health Science Authority (HSA) has announced that they will increase their review fees in Singapore for all registration routes. The increased government fees are equivalent to about a 5% increase across the board. For a complete list, please visit the HSA’s official revised schedule of fees. Singapore remains a beacon of regulatory efficiency and market entrance for international medical device manufacturers selling in Asia. With a high standard of living and several leading hospitals in the region, Singapore is an important market for all manufacturer serious about establishing their brand in Asia. Prices listed below are in Singapore Dollars (1 USD= 1.36 SGD according to the exchange rate on July 2nd, 2024)
New HSA Government Review Fees in Singapore
The HSA has announced that they will be increasing fees across the board in July 2024. Most fees have increased by about 5%, some of the updated fees can be found below.
| 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 Health Science Authority has also updated the change notification review fees in Singapore by about 5%. The application fee for Change of Registrant is now $880.
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 |
Grow with Us
Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in Singapore. Contact Asia Actual today if you have questions or need support importing medical products into Singapore.
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