Before you import or distribute medical devices in Indonesia, you must first register your products with the Ministry of Health (Kemenkes). Registering ensures all products sold or imported meet safety, quality, and performance standards in Indonesia. Approved devices receive a Nomor Izin Edar (NIE), allowing legal import, sale, and distribution in Indonesia's healthcare market.
In this guide, we will break down what you need to know about medical device registration in Indonesia. We’ll cover medical device classification in Indonesia, key pre-market requirements, and the step-by-step registration process.
Risk-based Classification System for Medical Devices
Indonesia follows the ASEAN Medical Device Directive (AMDD) for classification. It is a harmonized framework designed to align medical device regulations across Southeast Asia to ensure safety on a regional level.
Understanding where your device sits in this classification is crucial. It helps determine the depth of technical documentation required and evaluation timeline of your medical products.
| Risk Class | Description | Examples |
|---|---|---|
| Class A Low Risk (Non-Invasive) | Devices with minimal potential for harm to the patient or user. | Surgical masks, hospital furniture, bandages. |
| Class B (Low-Moderate Risk) | Devices with low to moderate risk levels that interact more closely with patients. | Hypodermic needles, pregnancy tests, suction equipment. |
| Class C (Moderate-High Risk) | Sophisticated devices requiring detailed technical and clinical review. | Ventilators, X-ray machines, orthopedic implants. |
| Class D (High Risk (Invasive) | Life-sustaining or invasive devices with the highest risk profile. | Heart valves, pacemakers, brain catheters. |
Mandatory Halal Certification: Class A devices must comply with Halal labeling/certification by October 17, 2026. Class B and Class C devices need Halal labeling/certification by 2029 and 2034 respectively.
Pre-requisites for Medical Device Registration in Indonesia
Before you submit an application, you need to understand the structural foundation of the Indonesian medical market. Compliance rests on three essential pillars: the local distributor, the product license, and the digital submission system.
1. Appoint a Local Representative
Foreign manufacturers cannot register medical devices directly with the Ministry of Health. You must appoint a Local Authorized Representative (LAR). This entity must hold a Medical Device Distributor License, known locally as IDAK (Izin Distribusi Alat Kesehatan).
You have three options:
- Establish a PT PMA: You can set up your own foreign-owned company. This gives you full control over your licenses and distribution but requires significant capital.
- Appoint a Third-Party Distributor: You can partner with a local distributor. While cost-effective, remember that they will "own" your product license (NIE) during the contract period.
- Use a Professional Importer of Record: Companies like Emerhub can act as your neutral representative, holding the license while you work with multiple distributors.
You must provide a formal Letter of Authorization appointing your Indonesian LAR/distributor for the specific device(s). This should be signed and notarized/legalized. Moreover, it should clearly state the authorized party and products.
2. Distribution and Operational Licenses
Under Permenkes No. 11 of 2025, foreign-manufactured devices are required to have distribution and operational licenses, qualified staff, facilities, and post-market reporting.
Whether you establish a PT PMA or engage with a LAR/distributor, either your entity or your partner must have following:
- IDAK (Medical Device Distributor License): legal permission for an Indonesian company to trade in medical devices. It is tied to the company's Business Identification Number (NIB).
- GDAKB (Good Distribution Practice for Medical Devices): operational certification that proves your local partner has the infrastructure (temperature-controlled warehouses, technical staff) to handle your products.
- Adequate Facilities and Personnel: Have an office, appropriate storage facilities (owned or leased for ≥2 years), and at least one qualified technical person in charge PJT (Penanggung Jawab Teknis).
Important: If your local partner’s IDAK or GDAKB expires or is suspended due to an audit failure, your product’s NIE is automatically frozen. You cannot import or sell until their operational license is restored.
3. Manufacturer Compliance (Quality Systems)
Kemenkes requires proof that the foreign factory that manufactured your products follows international standards. While the local partner holds the distribution permit, the manufacturer holds the responsibility for the quality system.
- ISO 13485 Certification: For imported products, this is the non-negotiable proof of your Quality Management System (QMS).
- Site Master File / Production Flow: Kemenkes evaluators will scrutinize the "how" and "where" of your production to ensure consistency.
Important: Registration timelines are often delayed because the manufacturer's name or address on the ISO 13485 doesn't match the Free Sale Certificate (FSC) exactly. Even a minor discrepancy like "Street" vs. "St." can cause a rejection. For a manufacturer, maintaining consistency across all international certificates is the key to passing the technical evaluation on the first try.
How to Register Medical Devices in Indonesia
Successfully meeting the pre-requisites is the essential groundwork for your product application. Once your Indonesian PT PMA is fully licensed or your LAR is formally authorized, you can then begin with the registration process.
Stage 1: Determine the Risk Classification of the Device
To start the medical device registration process, the first step is to confirm your device’s risk class (A, B, C, or D). This classification will help determine the depth of documentation needed to submit your registration application. For example, an orthopedic bone screw (Class C) requires higher “depth of documentation” than registering face masks (Class A).
Step 2: Application Submission via Regalkes Online System
Indonesia medical device registration is primarily done via the Regalkes online platform. Using your LAR’s/distributor’s existing REGALKES account, they will upload all the administrative documents to the portal. This includes the following:
- Notarized and apostilled Letter of Authorization (LoA)
- Notarized and apostilled Free Sale Certificate (FSC)
- Medical Device Distributor License (IDAK)
- Manufacturer’s QMS Certificate (e.g., ISO 13485 for foreign, CPAKB for local)
- Good Manufacturing Practice for medical devices (CDAKB) Certificate
- Product Label and Instructions for Use (IFU) in Indonesian language
- Device Description and Product Specification (intended use, materials, variants)
- Risk Analysis and Control Summary (per ISO 14971).
- Clinical Evidence (especially for Class C & D).
- Verification and Validation Data (e.g., electrical safety, biocompatibility, sterilization reports).
Stage 3: MoH Review and Evaluation
Regalkes will conduct two types of reviews for your medical device registration:
- An administrative review to check the completeness of your documents, and
- A technical review to evaluate your product’s safety, efficacy, performance, labeling and risk management.
Once the administrative check is passed, you enter the technical phase. This is where you submit the CSDT (Common Submission Dossier Template). Kemenkes evaluators will look at:
- Device description and specifications.
- Risk analysis and management.
- Manufacturing information.
- Verification and validation (test reports, clinical data).
If the MoH determines that the product does not meet necessary standards or the documentation is incomplete, they will request additional information. Your local authorized representative must respond within 10-15 working days to avoid application rejection.
Therefore, it is advisable to consult local regulatory experts such as Emerhub before application. We will assist in compiling and reviewing your entire submission package for compliance with Indonesian requirements before it goes to the Ministry of Health.
Step 4: Approval and NIE Issuance
If the evaluation is successful, you will receive a payment billing (PNBP). After payment, the Ministry of Health issues the NIE. Your NIE is your official medical device registration license. This number must be printed on all your product packaging and labels before the goods enter Indonesia. This certificate allows your medical device to be legally imported, sold, and distributed in Indonesia for 5 years, after which you must renew it.
Navigate Indonesia’s Medical Device Registration Process with Emerhub
Considering the strict regulatory guidelines and extensive requirements for medical device registration, it is advisable to consult local experts who understand these regulations.
Emerhub’s team of experienced regulatory consultants provides end-to-end support during the medical device registration process. We will help you set up your PT PMA company in Indonesia, or act as your license holder depending on your business goals. We can help protect your interests through clear agreements and compliant structures.
For more details, fill out the form below and get in touch with our regulatory experts.
Frequently asked questions
What is an NIE for medical devices in Indonesia?
NIE stands for "Nomor Izin Edar." It is the official product registration number issued by the Indonesian Ministry of Health once a medical device has been approved for marketing and sale in Indonesia.
Is Halal certification mandatory for medical devices in Indonesia?
As of June 2025, Halal certification is not yet mandatory for medical devices in Indonesia. However, Indonesia's Halal Product Assurance law is being phased in. Devices containing animal-derived materials must already carry a "Non-Halal" label if not certified Halal. Halal certification deadlines for medical devices are set by device class: Class A by October 2026, Class B by October 2029, Class C by October 2034, and the deadline for Class D devices is yet to be determined. It is advisable to assess your products for animal-origin components in advance to avoid potential issues in the future.
Do all medical devices require local clinical trials in Indonesia?
Indonesia generally does not mandate local clinical trials for devices that have existing substantial clinical evidence from recognized international markets (e.g., with CE marking or US FDA approval). However, the Ministry of Health may request local clinical evaluation or validation for certain new high-risk devices (especially Class D), novel technologies, or some IVDs to ensure performance on the local population.
Can foreign companies directly register medical devices in Indonesia?
No, foreign companies cannot directly submit applications for medical device registration. They must appoint a Local Authorized Representative (LAR) in Indonesia, which must be an Indonesian legal entity holding the appropriate distributor license (IDAK). The LAR will handle the registration process and hold the product license (NIE). If the foreign company wants to maintain control, it is strongly recommended to either establish their own company in Indonesia or appoint a license holder such as Emerhub.
What’s the difference between using an existing distributor to hold the product license (NIE) in Indonesia and using an independent license holder?
In Indonesia, the product registration license (NIE) is issued to a single local company, which gives that entity legal control over the importation and distribution of that specific product. Your product's access to the market is tied exclusively to that single partner. Since the NIE is generally non-transferable, switching to a new distributor in the future would likely require you to go through a completely new and lengthy product registration process under the new company. You separate the regulatory ownership from commercial activities. This gives you the flexibility to appoint one or multiple distributors and change them as your business strategy evolves, all without needing to re-register your device. While appointing your distributor can seem convenient initially, it can severely limit your long-term operational flexibility. Unless exclusivity is your specific strategic goal, using an independent license holder is often the more advisable route for maintaining control and scalability in the Indonesian market.
What is the difference between a Medical Device Distributor License (IDAK) and Medical Device Registration (NIE) in Indonesia?
The IDAK is a license for the Indonesian company (your local distributor, importer, or PT PMA). It authorizes that company to legally import, store, and distribute medical devices in Indonesia. As a prerequisite for any product registration activities, the IDAK process also includes an evaluation of the facility's readiness (e.g., warehouse suitability) and the appointment of a qualified Technical Responsible Person (Penanggung Jawab Teknis or PJT). NIE is a product-specific registration number issued by the Ministry of Health for each individual medical device. It confirms that the specific device has been approved and meets Indonesian safety and quality standards, allowing it to be legally marketed and sold.
How long does it take to register a medical device in Indonesia?
The timeline depends heavily on the risk class. Class A devices can be registered in 1-2 months. Class B and C typically take 3-6 months, while Class D can take 6-9 months or more, depending on the complexity of the technical evaluation and any "Additional Information" requests from the Ministry of Health.
Can I change my local distributor after the NIE is issued?
Yes, but the process is complicated. The NIE is tied to the local distributor who registered it. To change distributors, you generally need a "Transfer of License" agreement or wait for the existing license to expire. This is why many manufacturers choose a neutral representative like Emerhub to hold the license.
Do all medical devices need to be in Bahasa Indonesia?
The Instructions for Use (IFU) and the labeling on the smallest unit of packaging must be in Bahasa Indonesia. While English is often used alongside Bahasa, the local language is a mandatory requirement for safety and regulatory compliance.