Indonesia - Country Commercial Guide
Healthcare (Medical Devices & Equipment)

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2021-09-09

Unit: USD millions

 

 2018 

 2019 

 2020

 2021 (estimated)

Total Market Size

2,665

2,879

3,355

3,581

Total Local Production

1,757

1,933

2,126

2,291

Total Exports

590

604

955

1,002

Total Imports

1,488

1,550

2,183

2,292

Imports from the U.S.

135

169

192

207

Exchange Rate

14,236

14,147

14,582

N.A.

 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.

Overview

The population of Indonesia in 2021 is estimated to reach 275 million, which placed Indonesia at number 4 in population among the 195 nations of the world.

In 2020, a report published by Statistics Indonesia, the state-owned institute responsible for social and economic surveys, indicated that Indonesia had 17.9 million people aged 65 years and above. The elderly population is expected to grow by more than 40% by 2025, which will make Indonesia one of Asia’s fastest aging countries. This will have an enormous impact on an economic and societal level, particularly in the healthcare sector. The most common reported diseases among elderly Indonesians are hypertension, arthritis, stroke, oral health problems, chronic pulmonary diseases, and diabetes. A recent report released by the World Health Organization (WHO) indicated that stroke, ischemic heart disease, and diabetes are the top killers of elderly Indonesians.

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. As Indonesia’s public health insurance system grows to cover 230 million and more, there is great potential to build new hospitals, sell innovative medical equipment, and export patented pharmaceuticals. Total imports of medical devices and equipment grew from $1,550 million in 2019 to $2,183 million in 2020 and is expected to reach $2,292 million in 2021. U.S.-origin equipment accounts for approximately 10 percent of imports in the sector. (Source: U.S. Department of Commerce Global Trade Atlas (GTA).

Healthcare is a priority in Indonesia’s national agenda, and the central and regional governments continue to build and upgrade healthcare facilities. Indonesia currently has 2,925 hospitals, including 1,071 public and 1,854 private hospitals. In addition, there are over 10,134 public Health Community Centers (PUSKESMAS), which provide comprehensive basic 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 4,500 beds.

Medical equipment is subject to 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. Indonesia’s Government Regulation No. 31/2019 will require many types of goods to be halal certified in the future and will require products that originated from haram (forbidden) material to be labelled accordingly. 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.

The Indonesian government implemented an online procurement system (e-Catalogue) 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-Catalogue 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-Catalogue procurement system provides a publicly searchable database and ordering system for all listed medical devices and pharmaceuticals and their current list prices.

For U.S. companies, the e-Catalogue portal can be a rapid route to large sales volumes. However, to be listed in the e-Catalogue, companies have to 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-Catalogue 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-Catalogue system.  Private hospital tenders may result in higher prices for such medical devices.

There is no regular schedule for medical product e-Catalogue enrollment. The most recent e-Catalogue enrollment for medical products took place in early 2018. On December 10, 2020 the LKPP announced that the listing of all medical devices and pharmaceuticals that had originally be enrolled in early 2018 would expire at the end of December 2020. The LKPP also said it would finally launch a broad enrollment of new medical products, including imported products not related to COVID-19 treatment, in January 2021 and that it would try to complete the price negotiations by April 2021. Although the price negotiations were largely complete by the end of April 2021, the results have not been announced by the LKPP.

In June 2021, Indonesia introduced local content requirements banning imports of over 5,400 imported medical device products in 79 categories from the LKPP e-Catalogue 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-Catalogue system.

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 certification of Good Distribution Practices.

Based on Ministry of Trade regulations, companies in Indonesia are expected to engage 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 382200: Diagnostic or laboratory reagents.
  2. HS 901890: Other Instruments & Appliances used in Medical
  3. HS 901819: Instruments and appliances used in medical, surgical, dental or veterinary sciences.

Opportunities

Indonesia relies heavily on imported medical equipment and supplies to meet local demand. Most U.S. companies will find it most 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 operates 267 outlets and 142 clinical laboratories.

Resources

  • Ministry of Health
  • Directorate General of Pharmaceutical and Medical Devices, Ministry of Health
  • National Agency of Drug and Food Control (BPOM)

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

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