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市场信息
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.
医疗器械法规
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.
分类、费用、时间表
产品注册费
CLASS C
费用
CLASS B
费用
CLASS B
Immediate route
CLASS C
CLASS D WITH A REGISTRABLE DRUG
Full route
Full route (Priority Scheme 1)
$560
N.A.
N.A.
$3,340
$67
$134
$7,000
$560
N.A.
Expedited route
Full route (Priority Scheme 2)
Annual Retention (in SMDR)
$560
$560
N.A.
N.A.
Application for any
class B. C or D device
N.A.
$1,000
$3,340
$2,120
$3,340
$5,930
$2,120
$3,900
$6,250
$10,600
$3,900
$6,250
$12,000
$75,600
$4,420
$13,600
$5,660
$9,000
$17,500
$39
$134
CLASS D
Abridged route
$5,930
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 |
TURNAROUND TIME (TAT IN WORKING DAYS)
CLASS D WITH REGISTERABLE DRUG
CLASS D
Immediate route
Expedited route
Abridged route
Full route
Full route (Priority Scheme 1)
Immediate upon submission
Immediate upon submission
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
120
180
100
160
220
160
202
310
220
104
202
310
104
143
143
Full route (Priority Scheme 2)
N.A.
220
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.
产品注册途径
Route
Conditions
Immediate (IBR)
Medical Device Class
Immediate
Abridged
Expedited (ECR)
Expedited (EDR)
Full route (Priority Scheme Review)
Class A
Class B
Classes B,C & D
Classes B,C & D
Class C
-
Do not need product registration
-
Submit Class A Exemption List (Under manufacturer / importer license)
- Approved by at least 1 HSA reference agency
Class D
-
Approved by up to 2 of HSA's reference agencies
-
Sold legally for ≥ 3 years
-
No global safety issues / withdrawals
-
Approved by up to 2 of HSA's reference agencies
-
No global safety issues / withdrawals
-
Approved by up to 2 of HSA's reference agencies
-
Sold legally for ≥ 3 years
-
No global safety issues / withdrawals
-
No approval from HSA reference agencies
-
Follow Route 1 or 2 per Priority Scheme Review
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
-
Submit Class A Exemption List
(Under manufacturer / importer license)
-
Approved by up to 2 of HSA's reference agencies
-
No global safety issues / withdrawals
-
Approved by at least 1 HSA reference agency
-
Approved by up to 2 of HSA's reference agencies
-
Sold legally for ≥ 3 years
-
No global safety issues / withdrawals
-
Approved by up to 2 of HSA's reference agencies
-
Sold legally for ≥ 3 years
-
No global safety issues / withdrawals
-
No approval from HSA reference agencies
-
Follow Route 1 or 2 per Priority Scheme Review
有用信息
许可证有效期：12个月（可通过GIRO续期）
许可证转让：需要申请变更注册。
进口商和分销商：本地许可证持有人代表产品所有者负责指定进口商和分销商。
