Home Blog How US Manufacturers Can Import Medical Device Without Establishing a Company in Indonesia Indonesia | Medical Device | Product Registration How US Manufacturers Can Import Medical Device Without Establishing a Company in Indonesia InCorp Editorial Team 21 October 2024 5 minutes reading time Table of Contents Understanding the Medical Devices Industry in Indonesia Medical Device Product Categorization Market Size for Medical Devices in Indonesia Importing Medical Devices in Indonesia without Establishing a Company The Process to Register Medical Devices in Indonesia Documents Required for Indonesia Medical Device Registration Study Case: EOS Company Limited Unlock Indonesia's Medical Device Market with InCorp 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 ClassificationRegistration TimelineClass A Medical Device15 daysClass B Medical Device30 daysClass C Medical Device30 daysClass D Medical Device45 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 IndonesiaHow 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. Guide to Doing Business in Jakarta Mailchimp Free eBook Indonesia Business Insight Updates Full NameEmail I have read InCorp's Privacy Policy and agree to InCorp using my information provided to contact me about related content, and services.*Subscribe 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. Read Full Bio Verified by Daris Salam COO Indonesia at InCorp Indonesia With more than 10 years of expertise in accounting and finance, Daris Salam dedicates his knowledge to consistently improving the performance of InCorp Indonesia and maintaining clients and partnerships. Frequently Asked Questions What requirements are needed if my Indonesian company registers the product? Register the product with BPOM (National Agency of Food and Drugs) and MoH (Ministry of Health). The type of testing and document requirements depend on the type of product you want to register. Also, the time frame for registration could vary between 3 to 15 months. Can you provide pricing examples for the product registration services?v To provide you with accurate pricing information for our product registration services, we consider the complexities of your inquiries and the dynamic nature of regulations in Indonesia. As a result, the pricing for the service may vary accordingly. For detailed information, please get in touch with our consultants. What are the regulations on product distribution in Indonesia? You will need to register your products with the BPOM (National Agency of Food and Drugs) and MoH (Ministry of Health) before you can distribute them in Indonesia. It can only be registered with an Indonesian legal entity. Your local distributor will register your product in Indonesia under their entity and become the license holder if you distribute via the entity you choose. If my company is Halal certified for Europe or Malaysia, does it mean it is also Halal certified for Indonesia? The Indonesian Halal bodies recognize some of the international halal certifications. Nevertheless, since there might be differences in the standards used by each certification body, it is still necessary to process Halal Certification in Indonesia. Get in touch with us. Lead Form Newsletter Full NameEmailPlease provide corporate email where possiblePhone NumberOffice SetupWhich city are you planning to expand into?JakartaSemarang/Central JavaBali/LombokBatam/SumateraSurabaya/East JavaOther ProvincesType of Service- Please Select -[SPECIAL PACKAGE] Company Registration + Office Package (20% OFF)[SPECIAL PACKAGE] Product Registration + License Holder (20% OFF)Business SetupAccounting and TaxHR & Payroll servicesImmigration ServicesProduct Registration and ImportCompliance and Secretarial ServicesBusiness AdvisoryMore ServicesType of Service- Please Select -[SPECIAL PACKAGE] Company Registration + Office Service (20% OFF)[SPECIAL PACKAGE] Comprehensive Industrial Package (15% OFF)Business SetupAccounting and TaxHR & Payroll servicesImmigration ServicesProduct Registration and ImportCompliance and Secretarial ServicesBusiness AdvisoryMore ServicesType of Service- Please Select -[SPECIAL PACKAGE] Company Registration + Office Service (20% OFF)[SPECIAL PACKAGE] Comprehensive Industrial Package (15% OFF)Business SetupAccounting and TaxHR & Payroll servicesImmigration ServicesProduct Registration and ImportCompliance and Secretarial ServicesBusiness AdvisoryMore ServicesType of Service- Please Select -[SPECIAL PACKAGE] Company Registration (25% OFF) + Office Space (Private Office 30% OFF)[SPECIAL PACKAGE] Company Registration + Investor KITAS (25% OFF)[SPECIAL PACKAGE] Accounting + Tax Services+ Annual Fintax Report (20% OFF)[SPECIAL PACKAGE] Payroll Services for Executive Role (20% OFF)Business SetupAccounting and TaxHR & Payroll servicesImmigration ServicesProduct Registration and ImportCompliance and Secretarial ServicesBusiness AdvisoryMore ServicesType of Service- Please Select -[SPECIAL PACKAGE] Company Registration (20% OFF) + Office Service (25% OFF)[SPECIAL PACKAGE] Company Registration + Micro Finance Services (25% OFF)[SPECIAL PACKAGE] Property Assistance: Due Diligence + AJB Purchase/Lease Agreement (25% OFF)Business SetupAccounting and TaxHR & Payroll servicesImmigration ServicesProduct Registration and ImportCompliance and Secretarial ServicesBusiness AdvisoryMore ServicesType of Service- Please Select -Business SetupAccounting and TaxHR & Payroll servicesImmigration ServicesProduct Registration and ImportCompliance and Secretarial ServicesBusiness AdvisoryMore ServicesServices Company Registration Renting Virtual and Serviced Office Mergers and Acquisitions Business and Import Licenses Corporate Recovery and Insolvency Closing of Company (Dissolution) Land and Property Ownership Shelf Company Local NomineeServices Accounting and Tax Reporting Audit and Review Transfer Pricing Compliance Tax RefundHuman Resource Sub Services Payroll Outsourcing Employer of Record Recruitment and HR Establishment Employment ServiceServices Business Visa Work Permit and KITAS Dependent Visa (Spouse and Family) OtherBusiness Visa Subservices Business Visa Visit Visa Visa ExtensionServices Medical Device Beauty (Skincare and Cosmetic) Food and Beverage Health Supplement Household Product Halal Certification TrademarkServices Legal Consultation Legal Agreement Service Due Diligence and Background Check Company Documents RevisionBusiness Advisory Business Advisory Services ESG Reporting & Advisory Internal Audit Risk ManagementMore Services Market Research and Analysis Local Distributor and Partner Bank AccountMessageSubmit What you’ll get A prompt response to your inquiry Knowledge for doing business from local experts Ongoing support for your business 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. More on Indonesia A Guide to Timber Legality Assurance System Certificate in Indonesia Read more Indonesia Marine and Fisheries: Tax Strategies for High-Value Investments Read more The Importance of a Registered Business Address when Doing Business in Indonesia Read more