Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
FAQs
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
FAQs
U.S. Commercial Service Contact Information
Executive Summary
The population of Indonesia in 2019 is estimated to reach 267 million, which places Indonesia at number 4 in population among the 195 nations of the world.
In 2019, a report published by Statistics Indonesia, the state-owned institute responsible for social and economic surveys, indicated that Indonesia will have 17.3 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 equipment and supplies. Indonesia depends largely on imported medical equipment and supplies to meet local demand. Total imports of medical equipment grew from $1.4 billion in 2017 to $1.5 billion in 2018 and are expected to reach $1.6 billion in 2019. U.S.-origin equipment accounts for approximately 9 percent of imports in the sector.
Over 90% of the Indonesia’s medical equipment and devices are supplied by imports; imported products particularly dominate more sophisticated medical and surgical instruments and infrastructure, such as medical lasers and diagnostic equipment. In the past, domestic production focused mainly on the manufacture of basic items like surgical gloves, bandages, orthopaedic aids, and hospital furniture. Since 2016, local companies are able to produce other medical equipment, such as sphygmomanometers, stethoscopes, urine catheters, infant incubators, nebulizers, O2 concentrators, dental chairs, EKG equipment, fetal dopplers, syringe pumps, infusion pump, operating lamps, medical dressings (i.e. operating gown, bed sheets), rapid tests (i.e. HIV, Hepatitis, pregnancy to name a few), blood-grouping reagents, and first-aid boxes and kits.
Healthcare is a priority in Indonesia’s national development agenda. The central and regional governments continue to build and upgrade healthcare facilities. They are planning to equip community health centers (Puskesmas) with inpatient facilities and improve their quality of services throughout the 34 provinces.
The number of hospitals and clinics in Indonesia is growing while consumer spending in other areas has begun to slide. The government encourages private sector involvement in developing hospitals. This reflects the need for sophisticated medical equipment for high quality healthcare services. Key private players in the industry include Siloam Hospitals (which is part of Lippo Group), Omni Group, Mayapada Group and Sinar Mas Group as well as Prodia Group for diagnostic laboratories. As of January 2019, Siloam operates 36 state-of-the-art hospitals across the nation, and the number is expected to grow to 50 hospitals by the end of 2020.
According to the Directorate General of Health Services from the Ministry of Health, Indonesia currently has a total of 2,813 hospitals - 1,787 privately managed and 1,026 managed by the public sector. Those hospitals offer 310,710 hospital beds, or 1.17 beds per thousand population. This rate is the lowest in ASEAN and among the lowest in the world. Indonesia still lags far behind its ASEAN neighbors; Singapore, Thailand, Vietnam, and Malaysia average more than 2.0 hospital beds per thousand population.
In addition, major public and private laboratory chains are also expanding their operations in terms of capacity and geographic presence. The 6 major players in the industry are Prodia, Kimia Farma, Pramita, Cito, BioMedika and Parahita. The largest private laboratory chain, Prodia, currently operates 288 outlets and 141 clinical laboratories. Prodia is set to open 7 new outlets in 2019 (their strategic initiative for 2017-2020 is to open 33 new outlets throughout Indonesia).
Indonesia’s universal health care program, BPJS-Kesehatan (also referred to as JKN), was launched in 2014 and is expected to cover close to 100% of the Indonesian population with basic health care services in the coming years. It has undoubtedly contributed significantly to the growth of hospital and clinic businesses as the program has indirectly increased the number of patients. In administering health service, BPJS-Kesehatan has collaborated with 27,217 First Level Health Facilities (Community Health Centers, Individually Practicing Doctors, Pratama Clinics, Class D Hospitals and Dentists), 2,379 Advanced Level Referral Health Facilities (Hospitals and Primary Clinics), and 2,685 supporting health facilities such as Pharmacies and Optic care providers all over Indonesia. According to BJPS-Kesehatan, as of May 10, 2019, 221 million Indonesians were covered under JKN (83.94% of the total population). This program will increase demand for advanced medical equipment and supplies. U.S. manufacturers of medical equipment should take advantage of this growing market.
Although the implementation of JKN provides a strong increase in the demand for medical equipment and supplies, several challenges exist. The Indonesian healthcare system suffers from structural problems such as underfinancing, lagging numbers of primary care providers and hospitals, limited access to drugs in rural areas, and overall inaccessibility and inequity of care.
Market Entry
Prior to entering the Indonesian healthcare market, U.S. companies must either establish a foreign invested company in the form of a PT (limited liability company) or appoint a trustworthy local agent and/or distributor. It is mandatory to have an agent and/or distributor in order to serve the Indonesian market. Local agents and/or distributors handle registration for products and play an important role in developing the market and providing after-sales services. Attending conferences and events is a good strategy for meeting equipment importers, agents, and distributors.
U.S. companies are recommended to have a solid due diligence process in place and to consult with the U.S. Commercial Service prior to signing up agents and distributors. U.S. companies must visit the Indonesian market in order to properly choose an appropriate agent or distributor from Indonesia’s vibrant and experienced international business sector. Appointment of a representative requires care, since it is difficult to terminate a bad relationship. Qualified representatives will not take U.S. principals seriously unless they make a commitment to visiting the market on a regular basis. Patience, persistence and presence are three key factors for success in Indonesia.
Current Market Trends
According to Fitch Solutions’ Pharmaceuticals and Healthcare Report Q3 2019, healthcare spending in Indonesia, which amounted to US $38.3 billion in 2018, is expected to reach US $51 billion by 2020, and as a percentage of GDP healthcare spending is expected to rise from around 3.6% in 2018 to 4.18% in the same period. This report shows that Indonesia is still an attractive market for the health sector. The implementation of JKN has shifted the spending pattern in the healthcare industry. Government healthcare spending is expected to surpass private sector spending by a ratio of approximately 3:1by the end of 2020, with private sector spending amounting to 37.58% of the total healthcare expenditure, compared to government spending amounting to 62.42% of the total national healthcare expenditure. It also creates huge demand for advanced medical and surgical equipment like X-Ray machines, CT scanners, MRI machines, defibrillators, and gamma knives for incision-free surgeries, as well as different types of drugs related to the expected increase in the prevalence of diabetes and cardiovascular diseases. Profitable submarkets in dental equipment include devices for scaling and polishing, for bleaching, and for orthodontics. As for laboratory equipment, sustainable opportunities are related to test kits for hepatitis and infectious diseases, and for instruments related to clinical chemistry, haematology, and immunology.
Instruments and appliances used in medical, surgical, dental, or veterinary sciences, including scintigraphy apparatus, other electro-medical apparatus and sight-testing instruments, such as electro-cardiographs, MRI, CT scanners, and Ultraviolet or infra-red ray apparatus
Diagnostic or laboratory reagents
Machinery, plant or laboratory equipment, whether or not electrically heated, such as medical, surgical or laboratory sterilizers
Best Prospects
U.S. top three medical equipment export categories to Indonesia are:
HS 9018 – MEDICAL, SURGICAL, DENTAL OR VET INST, NO ELEC, PT
HS 3822 - COMPOSITE DIAGNOSTIC/LAB REAGENTS, EXC PHARMACEUT
HS 8419 – MACHINERY ETC FOR TEMP CHANG TREAT MAT; W HEAT, PT
Market Size
Healthcare Spending (Including Investment)
…as percent of GDP
3.6% (2018)
… of which spent on inpatient services (including long-term care)
N/A
… of which spent on pharmaceuticals/consumables
0.70% (2018)
… of which spent on investments
3.45% (2018)
… of which spent on outpatient services
N/A
Hospitals, Procedures, Healthcare Professionals UN: http://data.un.or g/Explorer.aspx?d=WHO
Number of Hospitals
2,813 (2018)
… Public
1,026 (2018)
… Private
1,787 (2018)
Number of Hospital Beds
310,710 (2018)
… available beds per capita
1.17 (2018)
… of which in general hospitals
281,082 (2018)
… of which in specialized clinics and rehab centers
29,628 (2018)
Number of Surgical Procedures
N/A
…of which [top procedure]
N/A
…of which [second highest procedure]
N/A
Physicians
101,356 (2018)
…of which surgeons
4,969 (2018)
…of which internists
6,627 (2018)
…of which pediatricians
6,793 (2018)
Dentists
2,458 (2018)
Demographics: http://www.geoba.se/country.php?cc=ID&year=2019
Population
266,910,000 (2019 est.)
Life expectancy men/women
70.84 / 76.27 (2019)
Infant mortality
21.14 deaths/1,000 live births (2019)
Percent of population older than 65
8.03% (2019 est.)
…projection, 2030
296 million
Annual Deaths
6.51 deaths/1,000 population (2019 est.)
…caused by [highest disease burden]
Cardiovascular diseases: 35% (2018)
…caused by [second highest]
Communicable diseases; maternal, prenatal and nutritional conditions: 21% (2018)
Prevalence of [fastest growing disease burden]
N/A
Main Competitors
The market for medical equipment and supplies is highly competitive. Leading suppliers to the market include both European and Asian manufacturers. The U.S. remains one of the leading suppliers with a total market share of over 9% in 2019. Germany is the leading supplier and is particularly strong in-patient aids, other medical devices, and diagnostic imaging equipment, where they account for nearly 20% of total imports. Other countries competing for market share in the medical equipment and supplies sector include China, Japan, and South Korea. Companies from China and South Korea provide the greatest challenge to U.S. firms as they offer lower-priced equipment and a sustained presence in the region. Therefore, while quality and after-sales service are essential elements, it is also important to price products competitively.
Current Demand
With the implementation of JKN, Indonesia will see a robust increase in the demand for medical devices and pharmaceutical products. The following have the largest market shares and provide huge opportunities for U.S. companies:
Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphy apparatus, other electro-medical apparatus and sight-testing instruments, such as electro-cardiographs, MRI, CT scanners, and Ultraviolet or infra-red ray apparatus
Diagnostic or laboratory reagents
Machinery, plant or laboratory equipment, whether or not electrically heated, such as medical, surgical or laboratory sterilizers
Registration Process
U.S. companies must be prepared to operate in an often-uncertain regulatory environment. Product registration can be lengthy, and new and changing requirements can hamper market entry, such as labeling and local content requirements. A strong local distributor or partner is critical to help navigate the product registration process and stay abreast of changing regulations.
The 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.
Medical equipment importers must submit a registration application to MoH’s Directorate General of Pharmacy and Medical Devices Services, which includes all of the following documents that the U.S. companies should supply:
Letter of Authorization (LoA) issued by the manufacturer, legalized by the Indonesian Embassy and a notary public in the U.S. and valid for at least five (5) years
Certificate of Free Sale from the authorized institution
Certificate of CE for ‘CE’ mark products or Certificate of ISO for ‘ISO’ mark products, if any
Formula/component/raw materials
Brief manufacturing process flow chart
Finished product specifications
Manual (instructions for use), which will be translated into the Indonesian language
The significant change promulgated in this new regulation is the approval timeline. Previously, medical device registration in Indonesia could take about 6-8 months. Now, the MoH has sped up the process to just 1-2 months between application and approval. The accelerated timeline is also applicable to changes and renewals of registration.
In addition, the MoH will be no longer be issuing hard copy certificates. Implementing electronic signatures on product approval is one method used by the MoH to accelerate medical device registration. The registration certificate will be issued in electronic form and can be printed by applicants or other interested agencies through the Indonesian National Single Window portal.
Reimbursement
The MoH is responsible for all procedures related to reimbursement. Thus, those covered by some form of public healthcare insurance can access healthcare services without financial trouble. In fact, public sector hospitals and other public healthcare facilities provide services either at a subsidized rate or free of charge.
Private and other public healthcare schemes reimburse hospitals on a fee-for-service basis. Negotiations between the insurance provider and healthcare service provider play a great role in determining the degree of reimbursement. Insurance providers reimburse the cost of hospital drugs of their members, only if drugs prescribed are listed in the insurer’s forms. Various public and private health insurance schemes use forms of their own. All these forms are in line with the National List of Essential Medicine (NLEM).
Under JKN, all existing insurance schemes will be merged. The biggest challenge in the path of JKN is the gap between the healthcare benefits covered by the plan and the actual healthcare services available in the country.
Private insurance providers cover both inpatient and outpatient services. High-income and upper-middle-income groups are the largest buyers of private insurance. Many international health insurance companies are present in Indonesia, including leading players such as Prudential, Manulife, Allianz, AXA, and AIA.
In Indonesia, healthcare insurance programs rarely reimburse all medical expenses and often require a high level of co-payments.
Barriers
Medical device registration in Indonesia is regulated by the MoH’s Directorate General of Pharmaceutical Services & Medical Devices, as well as the Directorate of Medical Device Production and Distribution Development. Although there is no restriction on the importation of medical equipment, the Indonesian government prohibits the import of used equipment. Medical equipment is subject to a 5-30% import tax. Electro-medical and other technical equipment have a tariff of 5% while medical supplies and plastics have a higher rate (20-30%). All imported medical equipment is subject to a 10% value added tax.
Indonesia shows good prospects for the healthcare medical device market; however, there are challenges that come with doing business in Indonesia, namely:
Corruption and bureaucratic inefficiency are an indisputable presence in the Indonesian market. U.S. companies should be patient and ready to face these challenges
The pricing of the products might also be a challenge for U.S. companies. The Indonesian medical industry has preference for high-quality products from the U.S., Europe, and Japan. The pricing of the product is important, considering the current USD exchange rate, which is slightly unfavorable compared to other currencies
Some regulations regarding medical devices might create a challenge for U.S. companies - for example, the mandatory registration of medical devices at the Ministry of Health of Indonesia (MoH) before clearance through Indonesian Customs. This process can be lengthy and can only be conducted by local distributors
Halal Law Implementation Update
On October 17, 2014, the Indonesian Parliament issued Law No. 33 of 2014 on Halal Product Assurance (“Halal Product Assurance Law”). The intention is to provide protection and assurance for halal products consumed by Indonesian citizens, the majority of whom are Moslem.
On April 29, 2019, the Government of the Republic of Indonesia issued Government Regulation No. 31 of 2019 (GR31/2019) concerning the implementation of Law No. 33 of 2014 on Halal Product Assurance. In this regulation, there are classifications of products that must be halal certified. Products that must be certified are divided into goods and services. Goods that must be certified are food, beverages, drugs, cosmetics, chemical, biological, genetically modified, and consumer goods that are worn, used, or utilized by the public and that originate from animal substances. Services that must be halal certified are slaughterhouses, processing, storing, packaging, distribution, selling and display. Non-halal products can still be sold but they will carry a non-halal label.
GR31/2019 emphasizes that the implementation of the Halal law, which is to begin in October 2019, will be done in phases, with food and beverages as a priority because they fulfill primary needs and are consumed massively. Many businesses in those sectors are already halal certified. Drugs, biological products, and medical devices that have non-halal materials and/or processing can still be marketed in Indonesia, but business owners must include information about the origin of materials or ingredients.
Details on the timeline of the phases and what kinds of products will be prioritized will be regulated by the Ministry of Religious Affairs (MORA). More provisions on drugs, biological products, and medical devices that still have non-halal materials and/or processing will be further regulated by a Presidential Regulation.
According to the latest draft Ministry of Religious Affairs Regulation (RPMA) on Phasing Out Halal Certified Products, the Indonesian government will implement Halal Law in two phases, allowing businesses time to comply:
Phase 1: Timeline for the gradual implementation of food and beverages products is effective from October 17, 2019 to October 17, 2024 (5-year grace period).
Phase 2: Timeline for the gradual implementation of non-food and beverages products (pharmaceuticals, consumer goods) is still under discussion with the relevant stakeholders such as the Indonesian Ministry of Health (MoH) and the National Agency of Drug and Food Control (BPOM).
Procurement & Tenders
Procurement by the government in Indonesia is regulated and facilitated by the Procurement Agency, LKPP (Lembaga Kebijakan dan Pengadaan Barang/Jasa Pemerintah). LKPP runs an online e-catalog website and a site for government tender information. Companies seeking to sell to the government should consider getting listed in the e-catalog, which must be done via an Indonesian company. Currently the e-catalog includes mostly heavy equipment, medicine and medical equipment, motorized vehicles, and technology (hardware and software). This procurement system is primarily for central government and the parliament, and local and provincial governments are gradually expected to start using it.
In 2014, the Government of Indonesia implemented an online purchasing system for medical devices that currently lists over 28,000 medical devices, along with distribution costs, in an e-catalog. The e-procurement system allows local medical facilities to purchase devices without a tender and aims to create transparency and simplify transactions. For U.S. companies, the portal is a means to fast-track exports and bypass red tape. However, to be listed in the e-catalog, companies must follow price caps imposed by the government, which can directly impact profit margins. As private hospitals have access to the catalog, they now have an upper hand in negotiating prices, which once again affects the bottom line. To manage the new obstacles and capitalize on a growing market, it is critical that U.S. manufacturers explore creative solutions with knowledgeable and savvy local distributors. In 2019, companies expect significant changes in e-catalog enrollment, which could make applications difficult. Enrollment for medical devices is being shifted from the Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah (LKPP- The Government Agency for Procurement of Goods) to the Ministry of Health. That said, an enhanced procurement system focused on the healthcare sector will make medical device procurement easier and more manageable in Indonesia.
All public tenders are published, but there are often listed specifications that require the knowledge and support of a local company to maximize the chances of success in a given procurement process. In order to apply for public tenders, a company must register at the government’s Procurement Portal INAPROC (https://eproc.lkpp.go.id/lpse) to be eligible to submit applications for any ongoing selection processes.
For tender offers, local distributors and/or agents need to comply with Indonesian standardization procedures as applicable. Government procurements prefer products with local content, to encourage domestic sourcing.
Indonesian Procurement https://eproc.lkpp.go.id/lpse
Healthcare Procurement http://www.lpse.depkes.go.id/eproc4
FAQs
1. How many classes of medical devices are there in Indonesia? Medical devices are classified into four (4) classes based on the risk level in case of malfunction/failure/misuse, namely: Class I (A)-Low Risk / In case of malfunction or misuse the device would not cause serious harm; Class II-A (B) and Class II-B (C)-Moderate Risk / In case of failure or misuse the device can have a significant impact on the health of patients, but not a serious accident; and Class III (D)-High Risk / The failure or misuse of these devices can result in serious implications for the patients or nurses/operators.
2. What is the timeline for Indonesia’s medical device registration process? On January 13, 2018, the MoH enacted a new regulation, Permenkes No. 62 Year 2017, concerning Marketing Authorization of Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies. The significant change in this new regulation is the approval timeline. Application review times for medical device registration were halved and are now as follows:
Class I (A): 15 working days
Class II-A (B) and II-B (C): 30 working days
Class III (D): 45 working days
3. How much is the registration fee for a medical device in Indonesia? Official guidance on fees for the processing of a Class I (A) is US $115 (IDR1,500,000). For Class II-A (B) and II-B (C), the fee is US $230 (IDR3,000,000). Class III (D) is processed for a fee of US $340 (IDR5,000,000).
4. Who can distribute medical devices and supplies in Indonesia? Importing medical devices and supplies can only be conducted by local companies that already have a Distributor License (Indonesian acronym: Ijin Penyalur Alat Kesehatan/IPAK) for the imported products. A Distributor License is issued by the MoH. Once the distributor license is obtained, it is valid indefinitely, and subject to a MoH audit every five years. Imported products must have only one legal importer and distributor in Indonesia.
5. Can a foreign hospital invest in Indonesian hospitals? Other than maternity hospitals, foreign investors can hold a maximum share of 67% in general hospitals (or 70% if the investor is domiciled in an ASEAN country). Please refer to the Presidential Regulation No. 44 Year 2016 regarding the Negative Investment List (Indonesian acronym: Daftar Negatif Investasi/DNI). In addition, foreign investment must also comply with the procedures under Indonesian Ministry of Health (MoH) Regulation No. 56 of 2014 to establish, manage, and classify a hospital.
6. Can a foreign hospital provide services in Indonesia? (e.g. advising Indonesian hospitals on efficient operations or patient experience, such as telemedicine for patients.) Foreign investors may build a whole new hospital or operate an existing local hospital jointly with a local investor. Foreign personnel in hospitals are limited to consultants’ roles and they do not give direct medical services. A recommendation from the MoH would be necessary for them to do so.
7. Is telemedicine currently being used? In order to improve access to and quality of Primary Healthcare, the MoH has included telemedicine in their 2015-2019 Strategic Plan. Implementation of telehealth in Indonesia has begun with tele-ECG and tele-radiology program initiated by Harapan Kita and Dr. Cipto Mangunkusumo General Hospital. Frost & Sullivan has reported that to address the increasing concern of maternal mortality in Indonesia, Philips run a pilot-project, Mobile Obstetrical Monitoring, in collaboration with local hospital group Bundamedik, the city government of Padang, West Sumatera, and the MoH. This project will remotely monitor pregnant women for early high-risk identification using a new tele-health solution.
Development of telemedicine solutions and software for healthcare has begun in Indonesia on a small scale. Close collaboration between the government and private sector is needed to bring this technology to its full potential. One of the challenges in bringing telemedicine to Indonesia is the lack of solid regulations. Telemedicine combines medical devices with IT, a combination that is unfortunately not clearly addressed in existing government regulations. What we have now is that the devices and software are regulated, but the space where they come together is a gray area that ends up inhibiting the use of medical technology.
U.S. Commercial Service Contact Information
Name: Pepsi MaryariniPepsi.Maryarini@trade.gov
