Registering Medical Devices In Indonesia

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.

The Growth in Number of Hospitals in Indonesia

Medical Devices in Indonesia

Despite the fact that Indonesia has some improvements (read: Business Overview in Indonesia), the healthcare expenditure per capita 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 still unequal between the urban and rural areas.

With JKN, it is expected that all Indonesians will receive equal coverage of healthcare services. It was reported that 48% of the population have been covered in 2014. Also all populations are expected to be in coverage in 2019.

Also, Indonesia currently only meets 10 percent of medical equipment needs. The government targets that the medical device needs will be met by 30% in 2030 (read also: Product Registration in Indonesia).

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 (read: Company Registration in Indonesia).

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 (read: Step by Step Guide to Start Business in Indonesia).

Registering Medical Devices in Indonesia: The Regulation

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 registering medical devices.

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.

Furthermore, medical devices are classified into several risk levels, each of which has its own registration procedure and requirements. In addition to understanding what requirements are needed, it is also important to note what general constraints that makes certain medical devices registrations rejected. Some of those are incomplete document requirements, expired documents, lack of understanding of online application, and lack of knowledge on updated information, regulation, or procedure (read: The Latest Negative Investment List).

Based on the regulation, foreign companies must have a professional a local partner or distributor in Indonesia. In order to be able to do medical device registration. The regulation is divided into 2 parts

1. Pre-market control

• There is rule for 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

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 order to completing all the requirements, until it’s legally registered. Send your email directly to sales@cekindo.com or contact us now and we will share you the detail steps and cost for registering your medical devices in Indonesia.