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 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 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 Indonesia service include:
- Local entity or representative: Foreign manufacturers must register through a PT PMA, local authorized 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 Indonesia service 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.
- Labeling 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.
Clear Paths to Product Registration in Indonesia
Medical device registration Indonesia service with InCorp
Indonesia’s medical device rules can change quickly, and one rejected dossier may delay your market entry by months. InCorp Indonesia (an 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.
Fill out the form below to get support from our medical device registration Indonesia service. We help you prepare the right local licenses and documents before submission.
Frequently Asked Questions
Can a foreign company register a medical device directly in Indonesia?
No. You must appoint a local distributor or establish a PT PMA holding a valid IDAK and CDAKB certificate to act as the registration holder.
How long does medical device registration take in Indonesia?
Roughly 1–2 months for Class A and up to 6–9 months for Class D, depending on dossier quality and MoH workload.
How long is an NIE valid?
The NIE (distribution permit) is valid for five years, or for the duration of the Letter of Authorization, whichever is shorter.
Is Halal certification mandatory for medical devices?
Not yet for all classes. Class A devices must comply by October 17, 2026, Class B by 2029, and Class C by 2034.
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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.
Verified by
Hotdo Nauli
Senior Legal & Delivery Manager at InCorp Indonesia
Hotdo heads the Legal and Delivery team at InCorp Indonesia, managing Product Registration, Legal Advisory, and Business Licensing. With over 8 years of experience, she focuses on compliance and integrity, ensuring all client operations align with Indonesian laws and regulatory standards, including contract reviews and sector-specific licenses. She is also a licensed advocate and a member of the Indonesian Advocates Association (PERADI).
