Overview

Unit: USD millions

Total Market Size = (Total Local Production + Total Import) - (Total Exports)

Source: Indonesian Medical Device Producers Association (ASPAKI), U.S. Department of Commerce TradeStats Express (TSE), and Global Trade Atlas (GTA) on Connect Trade Data. Average exchange rate of Indonesian Rupiahs to U.S. dollars from the World Bank.

18.6 million Indonesian were above the age of 65 according to Indonesia’s Statistics Bureau (BPS).  By 2025, 12.5% of Indonesia’s population will comprise of the elderly, a 45% increase from 2015 (8.6%). The most prevalent NCDs (non-communicable disease) in Indonesia are hypertension, heart disease, bronchial asthma, chronic renal failure, diabetes, stroke, and cancer. The deadliest diseases in 2019 were stroke, ischemic heart disease, and diabetes, which all experienced double digit percent increases from their totals a decade earlier in 2009.

As the fourth most populous country in the world, Indonesia offers great potential for U.S. exporters of medical devices and equipment. Although the Indonesian government has implemented local content requirements and import tariffs, Indonesia continues to rely on imported innovative medical devices. An increase in public awareness about the importance of healthcare, the expansion of public and private hospitals, and the implementation of Indonesia’s public health insurance system known as “BPJS-Kesehatan” (Jaminan Kesehatan Nasional, or JKN) in 2014, have led to an increased demand for more sophisticated and modern medical devices.  Per July 2023, the membership coverage has reached 258.2 million people, or around 90.34% of the total population in Indonesia.  This program will increase the demand for advanced medical equipment and supplies.  U.S. manufacturers of medical equipment should take advantage of this growing market.

Total imports of medical devices grew from 2,183 billion in 2022 to 2.633 billion in 2021.  Then, they decreased to 1.865 billion in 2022 because of the implementation of the Local Content Requirements (TKDN) policy by the Indonesian Government that freezes government purchases of 79 categories or over 5,400 imported medical device products.  U.S origin medical equipment accounts for 11.13 percent of imports in the sector.  (Source: U.S. Department of Commerce Global Trade Atlas -GTA).

Healthcare is a priority on Indonesia’s national agenda, and the central and regional governments continue to build and upgrade healthcare facilities.  Indonesia currently has 3,042 hospitals, with around 63 percent being privately managed. According to Indonesia’s Statistic Bureau (BPS), as of 2022, there are 10,374 public Health Community Centers (PUSKESMAS) that provide comprehensive primary healthcare and vaccinations.

In 2020, the Indonesian government began a process of promoting the consolidation of state-owned public hospitals in order to increase operational efficiency and quality of care through standardization. PT Pertamina Bina Medika, also known as Pertamedika IHC (Indonesia Health Corp), is the holding entity for state-owned hospitals and ranks as the second-largest hospital group in Indonesia with more than 6,500 hospital beds. As a company with the majority owner of Pertamina (Persero) which has a business in the health sector, Pertamedika IHC up to currently has 36 state-owned hospitals, 8 subsidiaries, 39 hospitals KSO, and 145 Pertamedika IHC Clinic Networks spread throughout Indonesia. Pertamedika IHC took the initiative to develop services globally by establishing the Bali International Hospital in collaboration with the Mayo Clinic.  The Bali International Hospital will be the centerpiece of the new Medical Special Economic Zone on Sanur Beach, owned and operated by Pertamedika IHC.

Medical equipment is subject to a 5% - 30% import tax, depending on the type, in addition to the standard 10% value added tax (Source: Indonesia’s Minister of Finance Regulation No. 6/2017 on Stipulation of Goods Classification and Charge of Duty Tariff on Imported Goods).  The Indonesian government prohibits the import of used or refurbished medical equipment. The Indonesian government requires halal certification for drugs, biological products, and medical devices (alkes) that enter and circulate in the country.  This regulation comes into effect on January 19, 2023.  This obligation is regulated in the Presidential Regulation (Perpres) Number 6/2023 concerning Halal Certification of Medicines, Biological Products and Medical Devices. Voluntary halal certification is scheduled to begin in 2021 but certification will not be mandatory for medical devices until the following dates: Class A Medical Devices: 2026; Class B Medical Devices: 2029; Class C Medical Devices: 2034; and Class D Medical Devices: 2039.

The Indonesian government implemented an online procurement system (e-Katalog) in 2014 for medical products that will be used under the national public health insurance system. The Government Agency for Procurement of Goods (Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah “LKPP”) manages the e-Katalog system, which was created to increase transparency and simplify transactions for products available for reimbursement under the national health insurance system. Thousands of medical devices and hundreds of pharmaceuticals are listed in the system, which allows public and private hospitals and clinics to purchase medical equipment at a pre-negotiated price without a national or hospital public tender. The LKPP e-Katalog procurement system provides a publicly searchable database and ordering system for all listed medical devices and pharmaceuticals, along with their current list prices.

For U.S. companies, the e-Katalog portal can be a rapid route to large sales volumes. However, to be listed in the e-Katalog, companies must negotiate prices with the government and the price negotiation criteria are not fully transparent. The prices are often negotiated within a fixed range based on a multiple of the import transfer price. And the cost of providing important professional education and training to local healthcare providers is not taken into account in price negotiations. As a result, prices offered in the e-Katalog system are lower than prices in the private health insurance market. Hospitals can also conduct their own tenders for medical devices that are not available via public tender or the e-Katalog system.  Private hospital tenders may result in higher prices for such medical devices.

In June 2021, Indonesia introduced Local Content Requirements (TKDN) banning imports of over 5,400 imported medical device products in 79 categories from the LKPP e-Katalog public procurement system used by hospitals and clinics. For those 79 categories, only locally manufactured medical devices certified to have 40% local content will be included in the e-Katalog system.

In February 2022, Indonesia’s Ministry of Health launched a sectoral e-Katalog for medical devices. Previously, e-Katalog was managed by LKPP and referred to as the national e-Katalog, for all products procured by government institutions street lighting to pacemakers. LKPP e-Katalog is now split into a national e-Katalog for items required nationally and sectoral e-Katalogs, specific to ministries such as the Ministry of Health. 

This means that medical devices, health-supporting tools, and household health products will no longer be reviewed by LKPP but by Indonesia’s Ministry of Health.

The sectoral e-Katalog for medical devices directly monitored by Indonesia’s Ministry of Health and LKPP and the Corruption Eradication Commission (KPK). The Ministry of Health launches the sectoral e-Katalog as a transformation of domestic procurement technology to be fast, transparent, independent, responsible, and credible. Domestic medical device manufacturers will get priority in the sectoral e-Katalog as long as they are qualified.

In July 2022, Indonesia’s Ministry of Industry issued Regulation 31/2022 regarding Provisions and Procedures for Calculation of Local Content Requirement (TKDN) for Medical Devices and In Vitro Diagnostic Medical Devices.  The local content calculation is divided into manufacturing aspects, such as raw materials, production, and packaging, which comprise 80 percent of the total calculation, with development aspects, including labor and factory overheads, taking the remaining 20 percent.  The regulation also includes detailed measures on each element, verification, and supervision implementation.

Indonesia Now Allows 100% Foreign Ownership of Medical Device Subsidiaries

Presidential Regulation No. 10 of 2021 on “Investment Business Fields” issued in February 2021 allows 100 percent foreign ownership in companies that import and obtain regulatory approval for medical devices. Previously, the 2016 Negative Investment List limited foreign ownership of companies that import and obtain regulatory approval of medical devices to a maximum of 49 percent.

This regulatory change is likely to result in more foreign investment in Indonesia because it provides foreign companies full legal control over the subsidiaries in Indonesia that obtain and control marketing authorization of their imported medical devices. It is also still possible for majority Indonesian-owned companies with regulatory expertise to obtain and hold the marketing authorization as the local representative of a foreign medical device manufacturer.

Obtaining a Medical Device Distribution Certificate (Sertifikat Distribusi Alat Kesehatan or SDAK) from the Ministry of Health is a basic requirement for companies to request marketing authorization and import their medical devices and diagnostic equipment into Indonesia. Ministry of Health Regulation No. 14 of 2021 on “Standards of Business Activities and Products on the Implementation of Business License Based on Health Risk” further stipulates that companies that apply to be a wholesaler of laboratory equipment and/or medical equipment for human use under Code 46691 of the Indonesia Standard Industrial Classification (Klasifikasi Baku Lapangan Usaha Indonesia or KBLI) are required to have a warehouse and to submit their certification of Good Distribution Practices.

Based on Ministry of Trade regulations, companies in Indonesia are expected to engage with one or more local distributors to distribute their medical device products to hospitals and clinics. To avoid duplication of efforts, some medical device importers outsource part or all of their warehousing functions to these local distributors, including quality control, packaging and labelling.

Presidential Regulation 10/2021 (Peraturan Presiden 10/2021 Tentang Bidang Usaha Penanaman Modal) can be accessed via these government of Indonesia websites:

The Audit Board of the Republic of Indonesia

https://peraturan.bpk.go.id/Home/Details/161806/perpres-no-10-tahun-2021 

Cabinet Secretariat of the Republic of Indonesia

https://jdih.setkab.go.id/PUUdoc/176391/Perpres_Nomor_10_Tahun_2021.pdf

Leading Sub-Sectors

The following sub sectors are among the leading U.S. exports in terms of export value:

1. HS 901890: Instruments and Appliances for Medical, Surgical or Veterinary Sciences Nesoi, and Parts and Accessories Thereof
2. HS 841990: Parts for Machinery, Plant or Laboratory Equipment for the Treatment of Material Involving Temperature Change (Except Domestic Machinery), Nesoi
3. HS  901813: Magnetic Resonance Imaging Aparatus

Opportunities

Despite protectionist measures to boost local manufacture of medical devices, Indonesia continues to rely on imported high-tech and advanced medical devices to meet local demand. Most U.S. companies will find it more beneficial to choose a local distributor to assist with product registration, import permits, and the logistics of importing and distributing their devices in the local market. Indonesian Ministry of Health (MoH) controls the process of registering medical devices and household health supplies in Indonesia.  In general, products that are FDA-approved and sold in the U.S. will be approved to enter the market in Indonesia.

Hospital and medical trade shows are good places to search for potential local partners in Indonesia. The association of medical device importers, Gakeslab Indonesia, is also a valuable resource for firms looking for experienced local partners. In Indonesia, medical buyers prefer high-quality products but are also highly price sensitive.

To gain market share, U.S. companies need to compete on quality, safety, efficacy and after-sales service for more innovative products. In summary, by entering the Indonesian market, medical device and equipment manufacturers can tap into a large market while helping Indonesia to improve its quality of care.

Key private players in the healthcare industry include Siloam Hospitals (Siloam International Hospitals which is part of Lippo Group), Mitra Keluarga (PT Mitra Keluarga Karyasehat), Primaya Hospital Group (previously Awal Bros Hospital Group), Omni Group (PT Sarana Meditama Metropolitan), Mayapada Group (PT Sejahtera Anugrahjaya), Pondok Indah Hospital Group, Ciputra Hospital (Ciputra Development), and Eka Hospital (Sinar Mas Group).

Major private laboratory chains are also expanding their operations in terms of capacity and geographic presence. The six major players in the industry are Prodia, Kimia Farma, Pramita, CITO, BioMedika and Parahita. The largest private laboratory chain, Prodia currently has 276 outlets of healthcare network spreading across 75 cities in 34 provinces in Indonesia.

Resources

• Ministry of Health https://www.kemkes.go.id/id/home
• Directorate General of Pharmaceutical and Medical Devices, Ministry of Health https://farmalkes.kemkes.go.id/

Interested parties may contact Commercial Specialist Pepsi Maryarini at Pepsi.Maryarini@trade.gov