medical device distributor in indonesia

How US Manufacturers Can Import Medical Device Without Establishing a Company in Indonesia

  • InCorp Editorial Team
  • 9 January 2024
  • 4 minute reading time

Indonesia’s national development agenda places a high focus on healthcare as health care facilities are being rigorously built and upgraded by the national and regional governments. In addition, the agenda calls for community health clinics (Puskesmas) to be equipped with inpatient units and to increase the quality of services in all 34 provinces of the country.

Meanwhile, consumer spending in other sectors has begun to decline as Indonesia’s hospitals and clinics continue to expand with the government’s assistance. Thus, it falls on the private sector to provide high-quality healthcare services, creating lucrative investment opportunities in the medical devices sector. In this article, we’ll discuss how manufacturers from the US can import medical devices through a medical device distributors in Indonesia without having to establish a company.

Indonesia’s Reliance on Imported Medical Devices

In 2019, Indonesia’s medical device industry was valued at USD 4.5 billion, however, the majority of its share (USD 2.8 billion) came from imports. With such intense reliance on imported medical equipment and supplies to meet the demand of the fourth most populous country in the world, Indonesia presents a great potential for US exporters of medical devices.

Following China (20% import), and Germany (15% import), the US products accounted for approximately 11% of Indonesia’s imports in 2019. U.S. companies must compete on quality, safety, efficacy, and after-sales service for more creative goods to obtain a bigger market share. There’s a huge market potential for US medical device suppliers to swoop in and make bank along with helping the country improve its healthcare system.

However, investing in Indonesia’s medical device industry isn’t without challenges. Engaging with medical device distributors in Indonesia to assist with product registration, import permissions, and the logistics of importing and selling their products in the local market is often crucial for the exporters of medical devices.

How to Import Medical Devices without establishing a company: Engaging with Medical Device Distributors in Indonesia

The Ministry of Health (‘MoH’) is responsible for medical device registration and marketing authorizations in Indonesia. However, only firms with a legal presence in the nation can register their items with the government.

Businesses from the United States need a considerable amount of capital to start up in Indonesia since the country has increased the paid-up capital for foreign-owned companies (PT PMA) to IDR 10 billion. Medical Device Distributor License (Izin Penyalur Alat Kesehatan, IPAK) is also required to distribute medical devices in Indonesia.

As an alternative to setting up a corporation, one can import medical devices into Indonesia by using the services of a reliable local agent and/or distributor. In addition to registering items, local agents and/or distributors can play a key role in growing the market and offering after-sales services to consumers.

Indonesia has a dynamic and experienced international business sector that can help American firms find the right agent or distributor.

The process to Register Medical Devices in Indonesia

Exporters or medical device distributors in Indonesia must file an application for registration with MoH’s Directorate-General for Pharmacy and Medical Device Services, which must contain certain documents with proper product information.

MoH has streamlined the product registration procedure, which now takes just 1-2 months from submission to approval. The expedited schedule also applies to registration modifications and renewals. This rapid relaxation of rules by the Indonesian government indicates its intention of drawing investment into the sector.

Cekindo As Your Medical Device Distributor in Indonesia

As an alternative to setting up a company in Indonesia, Cekindo acts as your medical device distributor in Indonesia. All tasks of product registration, import license, and a smooth distribution experience lies under the expertise of Cekindo.

Moreover, as your local agent, we will register and maintain your devices under our company’s ownership. Also, sales agreements allow for collaboration with numerous distributors.

Your items will be registered by Cekindo and we will keep your registration safe so that you can convert them to any other business at any moment.

EOS Company Limited, a manufacturer of soft contact lenses, approached Cekindo for market entry. Cekindo as their principal consultant helped them with timely company incorporation, product registration and obtained their licenses with the concerned authorities.

As a result, EOS Lens is now able to import and distribute its products in Indonesia through more than one distributor, allowing them to achieve higher market efficiency.

Pandu Biasramadhan

Senior Consulting Manager at InCorp Indonesia

An expert for more than 10 years, Pandu Biasramadhan, has an extensive background in providing top-quality and comprehensive business solutions for enterprises in Indonesia and managing regional partnership channels across Southeast Asia.

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Disclaimer: The information is provided by PT. Cekindo Business International (“InCorp Indonesia/ we”) for general purpose only and we make no representations or warranties of any kind.

We do not act as an authorized government or non-government provider for official documents and services, which is issued by the Government of the Republic of Indonesia or its appointed officials.

We do not promote any official government document or services of the Government of the Republic of Indonesia, including but not limited to, business identifiers, health and welfare assistance programs and benefits, unclaimed tax rebate, electronic travel visa and authorization, passports in this website.

Frequent Asked Questions

You can transfer the license as long as your current local distributor agrees to change the product license holder. The procedure will be different for each product category. We can only recommend you try to prevent these issues by setting cooperation with a trustworthy partner from the beginning

Before you can distribute your products in Indonesia, you will have to register your product with the BPOM (National Agency of Food and Drugs) and MoH (Ministry of Health). Only an Indonesian legal entity can register the product. If you decide to distribute your product via a local distributor, they will register the product under their entity in Indonesia and become the product license holder. Cekindo can act as your local distributor and register the product under its name.