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

Navigating the Indonesian market can be challenging for U.S. manufacturers looking to import medical devices. However, partnering with established medical device distributors in Indonesia offers a streamlined solution.

This article will discuss how U.S. manufacturers can import medical devices through medical device distributors in Indonesia without establishing a company.

Understanding the Medical Devices Industry in Indonesia

Indonesia’s medical device industry offers many investment opportunities for local and international companies. Key drivers of growth include a growing population, rising health awareness, and better industrial infrastructure. By 2029, the industry’s annual revenue is expected to surpass USD 3.2 billion, up from around USD 2 billion in 2023.

The government’s national health insurance program, Jaminan Kesehatan Indonesia (JKN-KIS), has played a major role in the industry’s expansion. Since its launch in 2014, JKN-KIS has made healthcare more accessible, increasing the demand for medical devices. Currently, it covers around 90% of the Indonesian population and is one of the largest national insurance schemes in the world.

Despite this growth, Indonesia still relies heavily on importing advanced medical technology. In 2022, medical equipment imports reached USD 1.9 billion, while exports were significantly lower at just USD 2.7 million.

Medical Device Product Categorization

Indonesia’s medical device classification aligns with the Global Harmonization Task Force (GHTF) guidelines and is being harmonized with the ASEAN Medical Devices Directive.

Devices are categorized into four classes based on risk, from low to high: Class A, B, C, and D. The registration process and timelines vary depending on the device’s classification.

Device Classification	Registration Timeline
Class A Medical Device	15 days
Class B Medical Device	30 days
Class C Medical Device	30 days
Class D Medical Device	45 days

Market Size for Medical Devices in Indonesia

According to Statista, the revenue in Indonesia’s medical technology market’s medical device segment is projected to grow steadily from 2024 to 2029, increasing by one billion U.S. dollars (+45.66%).

After nine consecutive years of growth, revenue is expected to reach 3.19 billion U.S. dollars by 2029, marking a new peak. It is worth noting that revenue in this segment has consistently risen over the past several years.

Opportunities for U.S. Exporters

As the fourth-most populous country, Indonesia heavily depends on imported medical equipment to meet its growing healthcare needs. This creates a significant opportunity for U.S. medical device exporters.

U.S. imports to Indonesia have fluctuated, starting at USD 192 million in 2020, peaking at USD 255 million in 2021, and dipping to USD 207 million in 2022, with a slight rebound to an estimated USD 221 million in 2023.

To gain a larger market share, companies must prioritize quality, safety, efficacy, and vital after-sales service, which are critical factors in competing in this market.

READ MORE:

• A Simple Guide to Medical Device Registration in Indonesia
• How to Register a Product and Get It Halal Certified in Indonesia: The Shortcuts

Importing Medical Devices in Indonesia without Establishing a Company

For businesses looking to enter the Indonesian market, importing medical devices can be a daunting task, especially when considering the complexities of establishing a local company.

Fortunately, there are effective alternatives that allow manufacturers to navigate this process without the need for company formation.

Regulatory Authority

• The Ministry of Health (MoH) is responsible for medical device registration and marketing authorizations in Indonesia.
• Only companies with a legal presence in the country can register their products.

High Startup Costs

• U.S. businesses need significant capital to start in Indonesia.
  • The required paid-up capital for foreign-owned companies (PT PMA) is IDR 10 billion.
• A Medical Device Distributor License (Izin Penyalur Alat Kesehatan, IPAK) is necessary to distribute medical devices.

Alternative Option

• Instead of setting up a company, businesses can import medical devices by:
  • Partnering with a reliable local agent or distributor.
  • These agents can help with:
    • Product Registration
    • Market growth
    • After-sales services for customers

The Process to Register Medical Devices in Indonesia

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

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

Documents Required for Indonesia Medical Device Registration

Registration applications must be submitted using the local form following the ASEAN Common Submission Dossier Template (CSDT).

The CSDT includes the following components:

• Executive Summary
• Device Labeling/Instructions for Use (IFU)
• Manufacturer’s Detailed Information
• Summary of Design Verification and Validation Documents
• Risk Analysis
• Quality Management Certification (ISO 13485)
• Clinical Evaluation Report
• Free Sales Certificate
• Risk Management Report
• Flow of the Manufacturing Process
• Raw Materials Used
• Design or Sterilization Validation
• Biocompatibility
• Declaration of Conformity
• Market History Confirmation from the Manufacturer
• Letter of Authorization
• Good Distribution Practice for Medical Devices (GDPMD)

Study Case: EOS Company Limited

EOS Company Limited, a leading soft contact lens manufacturer, partnered with InCorp to enter the Indonesian market smoothly. We assisted with company incorporation, product registration, and obtaining necessary licenses.

Thanks to our support, EOS Lens is now successfully importing and distributing its products through multiple channels, achieving greater market efficiency.

READ MORE:

• Will This New SEZ Be The Future of the Healthcare Industry in Indonesia?
• Permanent Business License and Permit: What You Need to Know About It

Unlock Indonesia’s Medical Device Market with InCorp

Are you looking to expand into Indonesia without the hassle of setting up a company? Let InCorp be your trusted medical device distributor. We take care of all the complexities, from product registration to import licenses and distribution, giving you a worry-free experience.

Why Choose InCorp?

Here’s what we offer:

• Product Registration: We handle all necessary paperwork and registrations for your medical devices.
• Import Licenses: We secure the licenses to import your products into Indonesia.
• Local Agent Services: Your devices will be registered under our ownership, giving you flexibility in the market.

Fill out the form below to unlock the full potential of Indonesia’s medical device market.