Complete guide to medical device registration Indonesia service for importers

Written by Hotdo Nauli | 04 November 2026

Medical device registration in Indonesia requires working with a local license holder, underscoring the importance of local licensing for a smooth process and assurance of compliance.

Before any product can be imported or sold, medical devices must also obtain a Distribution Permit (NIE). The process includes product classification, document preparation, licensing checks, and dossier submission to the Ministry of Health.

The requirements are strict, and mistakes can lead to delays, rejection, customs issues, or penalties. With the medical device registration in Indonesia service, companies can reduce resubmission risks and move through the registration process more smoothly.

Key Takeaways

Foreign manufacturers cannot register medical devices directly; a local entity, such as a PT PMA or appointed distributor with an IDAK license, must hold the registration.
Every medical device needs an NIE from the Ministry of Health before it can be sold in Indonesia, and the NIE is valid for 5 years.
Under Permenkes No. 11/2025, CDAKB certification is mandatory and integrated into the OSS system.
Medical device registration timelines range from 1–2 months for Class A devices to 6–9 months for Class D devices.
Non-compliance may result in fines of up to IDR 2 billion, customs detention, import bans, and halal certification obligations for Class A devices starting October 17, 2026.

Indonesia medical device classes and registration timelines

Indonesia classifies medical devices into four risk-based classes under the ASEAN Medical Device Directive (AMDD). The device class determines the required documents, the estimated approval timeline, and the halal certification deadline.

Class	Risk Level	Example Devices	Estimated Timeline	Halal Deadline
A	Low	Gauze, bandages, wheelchairs	1–2 months	17 October 2026
B	Low to Moderate	Surgical masks, syringes, and gloves	3–6 months	17 October 2029
C	Moderate to High	X-rays, ECGs, implants	3–6 months	17 October 2034
D	High	Life-support devices, certain IVDs	6–9 months	-

The higher the risk class, the more detailed the documentation and review process will be. Accurate classification at the start is crucial for a smooth registration in Indonesia.

How big is Indonesia's medical device market?

Indonesia's medical device market continues to grow, driven by healthcare expansion, hospital modernization, and digital health development through the SatuSehat platform.

The market was valued at around USD 2.37 billion in 2025 and is expected to grow by about 9.1% by 2030, making Indonesia a strong opportunity for medical device manufacturers and distributors.

Who regulates medical devices in Indonesia?

Medical device registration in Indonesia is regulated by the Ministry of Health (Kemenkes). The process is handled through the Directorate General of Pharmaceutical and Medical Devices, also known as Ditjen Farmalkes.

The main regulations cover distribution of licensing, risk-based licensing, and labeling requirements. These include Permenkes No. 62/2017, Permenkes No. 1190/2010, and Permenkes No. 11/2025.

Applications and supporting documents are submitted online through the Regalkes portal and the OSS-RBA system.

Documents required for the medical device registration in Indonesia service

Before registering a medical device in Indonesia, the applicant must prepare the right local structure, licenses, and supporting documents. These requirements help confirm that the product, manufacturer, and distributor meet Indonesian regulatory standards.

Key requirements for the medical device registration in Indonesia service include:

Local entity or representative: Foreign manufacturers must register through a PT PMA, local authorised representative, or appointed distributor.
Medical Device Distribution License (IDAK): Required to distribute medical devices in Indonesia.
Good Distribution Practice for Medical Devices (CDAKB): Required certification for medical device distributors and linked to OSS licensing.
Good Manufacturing Practice for Medical Devices (CPAKB): A quality standard for manufacturers.
ASEAN Common Submission Dossier Template (CSDT): Technical dossier format used for product registration.
Supporting documents: Includes NIB, NPWP, Letter of Authorization, Certificate of Free Sale, and, where needed, apostilled foreign certificates.

Preparing these requirements early helps reduce registration delays, document revision requests, and possible rejection during the NIE application process.

How to register a medical device in Indonesia

Medical device registration in Indonesia generally follows five main steps. These are:

Process	Description
Classify the Device	Identify whether the product falls under Class A, B, C, or D based on the ASEAN Medical Device Directive (AMDD).
Prepare the Local License Holder	Set up or appoint a local entity with a Medical Device Distribution License (IDAK) and Good Distribution Practice certification (CDAKB).
Prepare the Product Dossier	Compile the ASEAN Common Submission Dossier Template (CSDT) with required certificates and supporting documents.
Submit the Application	File the registration through Regalkes and OSS, then pay the Non-Tax State Revenue (PNBP) fee within the required timeline.
Receive Approval	Respond to Ministry of Health questions and receive the Distribution Permit (NIE) once approved. The NIE is generally valid for five years.

Before submitting your application, make sure your device classification, local license holder, and dossier documents are complete.

Our medical device registration Indonesia service streamlines the process, helping you avoid delays and ensure compliance. Contact our team to get started ->

Medical device compliance after NIE approval

Post-approval, maintaining ongoing compliance through regular reports and surveillance ensures your market presence remains secure and trustworthy.

E-report submission: Submit post-market reports every six months.
Labelling and packaging compliance: Ensure the product label and packaging remain consistent with the approved registration.
Post-market surveillance: Stay ready for Ministry of Health checks, including product sampling, vigilance monitoring, and advertising review.
AMDD compliance: Follow relevant ASEAN Medical Device Directive (AMDD) guidelines for post-market control.

Medical device registration Indonesia service with Ascentium Indonesia

Indonesia's medical device rules can change quickly, and one rejected dossier may delay your market entry by months. Ascentium Indonesia helps manufacturers manage the medical device registration process from classification to approval. Our support includes:

Device classification: Identify the correct risk class before submission.
Medical Device Distribution License (IDAK): Support the required distributor licensing process.
Good Distribution Practice for Medical Devices (CDAKB): Help prepare the certification needed for compliant distribution.
Distribution Permit (NIE): Manage dossier preparation and submission until approval.
End-to-end registration support: Coordinate the process across all four medical device risk classes.

We help you prepare the right local licenses and documents before submission.

Frequently Asked Questions

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