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市场信息
Malaysia’s healthcare expenditure was a total of RM78.2 billion in 2021 and is forecasted to steadily increase by 7.7% annually from 2023 to 2027.
Market Trend: The healthcare insurance market is projected to grow from $3.26 Bn in 2022 to $5.94 Bn by 2030,
Malaysia’s medical equipment market is expected to be worth US$2.0 billion in 2022, with a CAGR of 7.5%.
MDA, a federal statutory agency operating under the Ministry of Health Malaysia, holds the responsibility of overseeing the Malaysian medical device industry. Its mandate involves the enforcement of the Medical Device Act 2012 (Act 737) and aims to ensure public health and safety concerning medical devices while fostering the growth of the medical device trade and industry.
Medical Device Regulation
Medical Device Authority (MDA), under the MOH.
Regulation of medical devices done under the Medical Device Authority Act 2012 (Act 738) and its Medical Device Act (Act 737)
分类、费用、时间表
100 RM
750 RM
500 RM
3,000 RM
250 RM
Registration
Combination
N.A.
N.A.
Application
产品费用
1,000 RM
2,000 RM
5,000 RM
FEE | CLASS A | CLASS B | CLASS C | CLASS D | COMBINATION |
|---|---|---|---|---|---|
Application | 100 RM | 250 RM | 500 RM | 750 RM | N.A. |
Registration | N.A. | 1,000 RM | 2,000 RM | 3,000 RM | 5,000 RM |
TURNAROUND TIME (TAT)
DEVICE CLASS | TAT |
|---|---|
Class A | 1.5 - 2 months |
Class B | 3 - 6 months |
Class C | 3 - 6 months |
Class D | 3 - 6 months |
产品注册途径
DEVICE CLASS | CONDITIONS |
|---|---|
Class A | |
Classes B, C & D |
-
Completed submission in MedC@St2.0 system
-
Completed application of Common Submission Dossier Template (CSDT)
-
Submit application directly to MDA
-
Completed submission in MedC@St2.0 system
-
Completed application of Common Submission Dossier Template (CSDT)
-
Submit application a local accredited conformity assessment body (CAB) before submission to MDA
DEVICE CLASS | CONDITIONS |
|---|---|
Class A | |
Classes B, C & D |
-
Completed submission in MedC@St2.0 system
-
Completed application of Common Submission Dossier Template (CSDT)
-
Submit application directly to MDA
-
Completed submission in MedC@St2.0 system
-
Completed application of Common Submission Dossier Template (CSDT)
-
Submit application a local accredited conformity assessment body (CAB) before submission to MDA
有用信息
许可证有效期：5年。
许可证转让：许可证可通过“所有权变更”流程进行转让。
进口商和分销商：双方均须取得营业执照。
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