Indonesia Medical Device Registration
Register your Medical Devices in Indonesia
Emerhub helps you secure a Nomor Izin Edar (NIE) or Product Registration Number from the Ministry of Health (Kemenkes). We provide the expertise and local representation you need to enter the Indonesian medical device market.
| 198+ products registered in Indonesia
What You Need to Know About Medical Device Registration
Medical device registration is overseen by the Ministry of Health (Kemenkes or MoH) in Indonesia. The agency oversees pre-market evaluation, evaluation, registration, Good Manufacturing Practice (GMP) certification, and post-market surveillance.
Medical Device Classification
Medical devices in Indonesia are categorized into four risk classes based on the ASEAN Medical Device Directive (AMDD). The classification dictates documentation requirements, fees, and review timelines. For example, low-risk devices require minimal scrutiny in contrast to high-risk devices. Before you register, you must know what is the medical classification of your device.
| Class | Examples |
|---|---|
| Class A (Low risk) | Bandages, examination gloves, walking canes |
| Class B (Low to moderate risk) | Surgical masks, blood pressure monitors, syringes, infusion sets |
| Class C (Moderate to high risk) | Diagnostic equipment (x-ray machines, ECG monitors, etc.), ventilators, orthopedic implants |
| Class D (High risk) | Pacemakers, heart valves, high-risk IVDs |
Setting up a PT PMA or Appointing a LAR
If you are a foreign medical device manufacturer who want to enter the Indonesian market, you must either appoint a Local Authorized Representative (LAR) or set up a PT PMA to register a medical device in Indonesia. Each pathway has its own set of requirements.
The choice between appointing a LAR or setting up a PT PMA depends on your business strategy, investment capacity, and willingness to assume local operational responsibility. Both routes comply with regulatory requirements ensuring devices have a local accountable entity for registration and market access.
Pre-requisites Before Registration
Before you register a medical device in Indonesia, you must meet pre-requisites to ensure compliance with Kemenkes regulations. These requirements ensure that your products meet the safety standards, safety, and regulatory harmonization within ASEAN.
Distribution and Operational Licenses
Whether you establish a PT PMA or with a LAR, you must have the following:
Medical Device Distributor License (IDAK/IPAK)
Provides authority to distribute or import medical devices in Indonesia within the relevant category.
Good Distribution Practice (CDAKB) Certificate
Ensures that distributors comply with Good Distribution Practice standards and demonstrates the ability to maintain product integrity and safety throughout the supply chain.
Adequate Facilities and Personnel
Ensures that you have adequate facilities (owned or leased for more than 2 years), and at least 1 qualified person-in-charge.
Manufacturer Compliance
Ensures adherence to Good Manufacturing practices to ensure a market access and regulatory approval in Indonesia.
Foreign Manufacturers
Must provide evidence of a Quality Management System (QMS), typically demonstrated by an ISO 13485:2016 certification.
Local Manufacturers
Required to have a production certificate issued by the Indonesian Ministry of Health (MoH) and must implement Good Manufacturing Practices for medical devices (CPAKB).
Letter of Authorization
If you’re working with a LAR, you must have a formal Letter of Authorization. This document should be signed and notarized and must clearly state the authorized party and products.
Register your Medical Device with Emerhub
Emerhub simplifies Kemenkes compliance so you can focus more on distribution. We eliminate the guesswork and accelerate your time-to-market.
The Product Holder Solution
As your local representative, we provide the fastest and most flexible way to enter the Indonesian market without setting up your own entity.
CSDT & REGALKES Expertise
We handle the entire dossier preparation process, ensuring your documentation adheres to the CSDT format and MoH requirements.
Post-Market Surveillance & Renewal
We manage your post-market surveillance obligations, change notifications, and guarantee timely renewal applications before your NIE expires.
Local Entity Solutions
We also provide you the option to setup your own PT PMA and assist you with the incorporation process from business name registration to tax compliance and setting up a local bank account.
Schedule a free consultation with one of our local experts in Indonesia.
FAQs About Medical Device Product Registration
If you are a foreign manufacturer, you must appoint a local Indonesian legal entity with with an IDAK or establish a PT PMA to act as the license holder. This local entity submits the application via REGALKES and is responsible for post-market compliance. Emerhub can act as your LAR to manage the medical device registration process.
Yes. In-Vitro Diagnostic devices are regulated by Kemenkes and follow the same four-tiered risk classification system (Class A, B, C, D) and submission process as general medical devices. They must also obtain an NIE and be registered by a local License Holder.
Halal certification is being phased in for medical devices under Indonesian law. The requirement deadline varies based on the risk class:
- Class A: October 17, 2026
- Class B: October 17, 2029
- Class C: October 17, 2034
You must comply with these deadlines or label non-compliant products accordingly. Emerhub can assist with navigating this evolving compliance landscape.
The LoA from the manufacturer must be signed, ideally cover the full 5-year NIE term, and be authenticated. Since Indonesia joined the Hague Apostille Convention (June 2022), the LoA must typically be apostilled in the country of origin, which replaces the need for local Indonesian embassy legalization.
NIEs are generally non-transferable. To change distributors, the existing registration must usually be canceled, and a new application must be submitted by the new distributor. This process requires the cooperation of the previous LAR. If cooperation is withheld, the MoH mandates a waiting period (up to 6 months) before you can reapply.
Schedule a call with an Emerhub Consultant
Tell us about your plans. We’ll reach out to discuss your needs and how we can help you.
Email Us
indonesia@emerhub.com
Call Us
+62 21 2205 7930
Visit Us
Satrio Tower Floor 26, Unit C and D, RT.7/RW.2,
Kuningan, Jakarta 12950, Indonesia