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Registering Medical Devices In IndonesiaJakarta, December 2016
2For further info, visit: www.cekindo.com.email to: [email protected], phone: 021-80660999
The Overview
Healthcare system in Indonesia is currently showing significant progress. Since the launch of the universal healthcare program by the government in January 2014, known as Jaminan Kesehatan Nasional(JKN), Indonesia has made some improvements in its healthcare service.
There is a significant growth in the number of hospitals, with 130 new general hospitals and 50 new specialty hospitals in 2014. There is also a prominent growth in the number of Puskesmas (government-mandated community health clinics) that impact on better promotion of health care awareness, especially among the low-income communities.
3For further info, visit: www.cekindo.com.email to: [email protected], phone: 021-80660999
The Growth In Number Of Hospitals In Indonesia
Medical Devices In Indonesia
4For further info, visit: www.cekindo.com.email to: [email protected], phone: 021-80660999
Despite the fact that Indonesia has some, the healthcare expenditure percapita in Indonesia are still quite low, even one of the lowest in the world,with only 2.9% of its GDP in 2014. And the healthcare standards are stillunequal between the urban and rural areas. With JKN, it is expected that allIndonesians will receive equal coverage of healthcare services. It wasreported that 48% of the population have been covered in 2014 and allpopulations are expected to be in coverage in 2019. Also, Indonesia currentlyonly meets 10 percent of medical equipment needs. The government targetsthat the medical device needs will be met by 30% in 2030.
Medical Devices In Indonesia (cont’d)
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All these factors cause a higher demand on more modern and sophisticated
medical devices. The growing population with more than 240 million citizens
have also represented one third of all ASEAN medical devices market,
making Indonesia ASEAN country with the most emerging market in
medical devices. The nation’s economy has also been steady for the last few
years, and this results in a huge potential for future growth in medical
device market. CAGR predicts that the growth rate of Indonesia’s medical
market is 12.7% for the next 5 years. With local manufacturers produce
primarily basic and disposable products, Indonesia still relies predominantly
on imported medical devices from foreign manufacturers.
The Regulation
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Indonesia has been regulating medical device since 1991 to ensure safety, quality,
as well as affordability, to further avoid risk in medical devices and reduce cost
on public health care. Distributors and manufactures deciding to enter the market
in Indonesia must follow and fulfill all those regulations regarding the medical
devices registration. Firstly, it is important to know what medical devices are
meant by the regulation. In Regulation of the Minister of Health of the Republic of
Indonesia No. 1190/MENKES/PER/VIII/2010-Regarding Medical Devices and
Household Products, medical devices are the instruments, apparatuses, machines
and/or implants that do not contain drugs used to prevent, diagnose, cure and
relieve diseases, treat sick people, recover health of human beings, and/or form
the structure and correct the body function.
The Regulation (cont’d)
7For further info, visit: www.cekindo.com.email to: [email protected], phone: 021-80660999
Furthermore, medical devices areclassified into several risk levels, each ofwhich has its own registration procedureand requirements. Besides understandingwhat requirements are needed, it is alsoimportant to note what generalconstraints that makes certain medicaldevices registrations rejected. Some ofthose are incomplete documentrequirements, expired documents, lack ofunderstanding of online application, andlack of knowledge on updatedinformation, regulation, or procedure .
Based on the regulation, foreign companies must have a professional a local partner or distributor in Indonesia to be able to do medical device registration. The regulation is divided into 2 parts.
#1. Pre-market Control
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• In this part, every foreign company that wants to sell or distribute their products in Indonesia must obtain Manufacturer License (ISO 13485 for QMS), Distribution License (Good Distribution Practice), and Registration License (ASEAN CDST).
• If the registration is approved, the next step is the administration and payment. Each payment is different, based on what risk level the products registered belongs to.
• When administration and payment is done, you need to submit all documents required. Those documents will further be submitted to expert team for approval.
• When the license has been approved by Minister of Health, the company continues to apply for product licenses. It covers the labeling of the product packaging, manual book and IFU (both in Indonesian and original language), and brochure/leaflet (both in Indonesian and original language). Besides that, the company should also provide some requirements which are different for each class of product. Special requirements may also be needed for certain types of medical devices.
• It will generally take 6-12 months for all the process to complete.
#2. Post-market Control
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Post-market control is guided by ASEAN AMDD guideline and it includes sampling, monitoring, vigilance, and advertising.
HOW CEKINDO CAN HELP YOU
Cekindo already assisted many companies in terms of company registration, business set up, product registration, and of course medical devices registration in Indonesia.
We will fully assist you in completing all the requirements, until it’s legally registered. Send your email directly to [email protected] or contact us now and we will share you the detail steps and cost to register your medical devices in Indonesia.
References:• http://www.geologinesia.com/2016/01/perkembangan-puskesmas-dan-rumah-sakit-di-
indonesia.html
• https://bisnis.tempo.co/read/news/2016/11/22/090822036/pasar-industri-alat-kesehatan-indonesia-potensial
• http://www.who.int/countries/idn/en/
• http://www.tradingeconomics.com/indonesia/gdp-growth
• http://www.s-ge.com/sites/default/files/private_files/Marktstudie%20S-GE-Medical%20Devices%20in%20Indonesia.pdf
• http://www.morulaa.com/medical-device/market-overview-indonesia-medical-device-market/
• http://www.eibn.org/upload/EIBN_Indonesia_Medical_Device_regulation.pdf
• http://www.morulaa.com/indonesia-medical-device-registration-moh-ri/
• http://www.pacificbridgemedical.com/regulatory-services/medical-device/product-registration/indonesia/
• http://cci-indonesia.com/2016/07/29/jumlah-rumah-sakit-di-indonesia/
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Minister of State for Research and Technology of the Republic of Indonesia and Chairman of the Agency for Assessment and Application of Technology (BPPT) in the Seventh Development Cabinet of the Republic of Indonesia.
Minister of Industry and Trade in the Development Reforms Cabinet of the Republic of Indonesia and Chairman of National Logistic Agency.
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Several management positions and responsibilities related to Indonesian Aviation industry, the Weapon industry.
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