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全球>东盟>
市场信息
Indonesia’s healthcare expenditure was IDR 490.3 trillion ($33.4 billion) in 2019 and is projected to rise to IDR1,224 trillion ($78.0 billion) by 2027.
Market Trend: In 2022, the Indonesian Social Security Administrator for Health, or BPJS Kesehatan, recorded about 248 million beneficiaries of the Indonesian national health insurance-Indonesian health card (JKN-KIS)
Indonesia’s medical equipment market is expected to show an annual growth rate (CAGR 2023-2028) of 6.80%, resulting in a market volume of US$2.71bn by 2028.
The Indonesian Ministry of Health’s Directorate General of Pharmaceuticals and Medical Devices (Ditjen Farmalkes) regulates medical devices through its Directorate of Medical Device and Household Health Supplies Supervision. It oversees device classification, registration, import permits, and post-market surveillance based on a risk-based system from Class A to D. Registration is conducted via the online SiRegAlkes portal, with recognition of approvals from trusted regulatory authorities for certain products.
分类、费用、时间表
MEDICAL DEVICES & In Vitro Diagnostics (IVD)
DEVICE CLASS | FEES | TIMELINE (LOCAL) | TIMELINE (IMPORT) |
|---|---|---|---|
Class A | 1,500,000 RP | 30 days | 35 days |
Class B | 3,000,000 RP | 40 days | 50 days |
Class C | 3,000,000 RP | 40 days | 50 days |
Class D | 5,000,000 RP | 55 days | 70 days |
PERBEKALAN KESEHATAN RUMAH TANGGA (PKRT) - Household Health Supplies
DEVICE CLASS | FEES | TIMELINE |
|---|---|---|
Class 1 | 1,000,000 RP | 45 days |
Class 2 | 2,000,000 RP | 60 days |
Class 3 | 3,000,000 RP | 75 days |
产品注册途径
Must be registered with the Ministry of Health via the Online Medical Device Registration platform.
MEDICAL DEVICES & In Vitro Diagnostics (IVD)
DEVICE CLASS | DESCRIPTION |
|---|---|
Class A | Low risk |
Class B | Low to moderate risk |
Class C | Moderate to high risk |
Class D | High risk |
PERBEKALAN KESEHATAN RUMAH TANGGA (PKRT) - Household Health Supplies
DEVICE CLASS | DESCRIPTION |
|---|---|
有用信息
执照有效期：2至5年（取决于授权书的有效期）。
执照转让：取消原执照并提交新的申请。
进口商和分销商：必须获得IDAK/MDDL或SDAK/MDDC。
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