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Market Information
Singapore’s healthcare expenditure was projected to reach $21.4 billion in 2020, marking a 9% increase from the previous year's $19.6 billion. The forecast suggests that by 2029, this market is anticipated to surpass double its size, reaching $49.4 billion. Anticipated to include both public and private healthcare expenses, Singapore's healthcare spending is expected to represent 5.9% of the GDP, potentially rising to 9% by 2029.
Market Trend: All Singaporeans have basic medical insurance in the form of MediShield Life. Another 69% have the Integrated Plan on top of the basic insurance.
Singapore’s medical equipment market is expected to display an annual growth rate (CAGR 2023-2028) of 6.48%, leading to a market volume of 1.12 million USD by 2028.
The Health Sciences Authority (HSA) was formed in 2001 when voluntary registration was introduced. HSA regulates medical devices including IVDs under the Health Products Act 2007. All products are approved by the Medical Device Branch of HSA before it can be supplied in Singapore.
Medical Device Regulation
Health Science Authority (HSA), under the MOH.
Regulation of medical devices done under the Health Products Act (HPA) and its Health Products (Medical Devices) Regulations 2010.
Classification, Fees, Timeline
FEES | CLASS B | CLASS C | CLASS D | CLASS D WITH REGISTRABLE DRUG |
|---|---|---|---|---|
Application for any class B, C or D device registration | $560 | $560 | $560 | $560 |
Immediate route | $1,000 | $3,340 | N.A. | N.A. |
Expedited route | N.A. | $3,340 | $5,930 | N.A. |
Abridged route | $2,120 | $3,900 | $6,250 | $10,600 |
Full route | $3,900 | $6,250 | $12,000 | $75,600 |
Full route (Priority Scheme 1) | $4,420 | $7,000 | $13,600 | N.A. |
Full route (Priority Scheme 2) | $5,660 | $9,000 | $17,500 | N.A. |
Annual Retention (in SMDR) | $39 | $67 | $134 | $134 |
PRODUCT REGISTRATION FEES
TURNAROUND TIME (TAT IN WORKING DAYS)
FEES | CLASS B | CLASS C | CLASS D | CLASS D WITH REGISTRABLE DRUG |
|---|---|---|---|---|
Immediate route | Immediate upon submission | Immediate upon submission | N.A. | N.A. |
Expedited route | N.A. | 120 | 180 | N.A. |
Abridged route | 100 | 160 | 220 | 220 |
Full route | 160 | 220 | 310 | 310 |
Full route (Priority Scheme 1) | 104 | 143 | 202 | N.A. |
Full route (Priority Scheme 2) | 104 | 143 | 202 | N.A. |
Annual Retention TAT is when retention payment is successfully paid before the deadline.
Product Registration Routes
Route | Medical Device Class | Conditions |
|---|---|---|
Immediate | Class A | |
Immediate (IBR) | Class B | |
Abridged | Classes B, C & D | |
Expedited (ECR) | Class C | |
Expedited (EDR) | Class D | |
Full route (Priority Scheme Review) | Classes B, C & D |
-
Do not need product registration
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Submit Class A Exemption List
(Under manufacturer / importer license)
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Approved by up to 2 of HSA's reference agencies
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No global safety issues / withdrawals
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Approved by at least 1 HSA reference agency
-
Approved by up to 2 of HSA's reference agencies
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Sold legally for ≥ 3 years
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No global safety issues / withdrawals
-
Approved by up to 2 of HSA's reference agencies
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Sold legally for ≥ 3 years
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No global safety issues / withdrawals
-
No approval from HSA reference agencies
-
Follow Route 1 or 2 per Priority Scheme Review
Useful Information
Validity of License: 12 months (Renewable through GIRO)
License transfer: Change of Registration application needed.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
