ASEAN
INDONESIA
Market Information
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 devices in Indonesia are regulated by the National Agency of Drug and Food Control (NADFC) functioning under the Indonesian Ministry of Health (MoH).
Medical Device Regulation
Classification, Fees, Timeline
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Product Registration Routes
Class A, B, C, D (Medical Device & IVD)
Class 1, 2, 3 (PKRT - Household Health Supplies)
Must be registered with the Ministry of Health via the Online Medical Device Registration platform.
Useful Information
Validity of License: 2 to 5 years (depending on the validity period of Letter of Authorization).
License transfer: Cancel the original license and file a new application.
Importer and Distributor: Must obtain an IDAK/MDDL or SDAK/MDDC.
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