Medical device registration in Indonesia
Every medical device and in-vitro diagnostic needs a Nomor Izin Edar (NIE) from the Ministry of Health before it can be sold in Indonesia. Emerhub’s local experts assess the classification of your medical device and handle registration on your behalf.
Understanding Indonesia's medical device regulations
To import, manufacture, or sell a medical device in Indonesia, it first has to be registered with the Ministry of Health, which issues a Nomor Izin Edar (NIE), the marketing authorization that allows the device to be sold. The NIE is issued per product, each device under its own name. Therefore, a catalog of ten medical devices means ten registrations. Furthermore, every medical device is assigned a risk class based on assessment, which then determines the documentary requirements and timeline for registration.
A foreign manufacturer cannot hold the NIE directly. It registers on the imported side, coded AKL, either through its own PT PMA or through a local representative that holds the NIE on its behalf. Either way, that holder must already carry its company-level distribution licences before the Ministry will review a single product.
Medical device classification in Indonesia
Indonesia uses the four ASEAN risk classes. The class sets the documentation, the fees, and the review timeline, so a higher class needs fuller evidence, including clinical data. In-vitro diagnostics follow the same four-class scale, under rules written specifically for them.
| Class | Risk level | Examples |
|---|---|---|
| Class A | Low | Bandages, examination gloves, walking canes |
| Class B | Low to moderate | Surgical masks, blood pressure monitors, syringes, infusion sets |
| Class C | Moderate to high | Diagnostic equipment such as X-ray machines and ECG monitors, ventilators, orthopedic implants |
| Class D | High | Pacemakers, heart valves, high-risk in-vitro diagnostics |
Check your device’s classification
Search 2,600+ device types to find your risk class, A to D, and what it means for registration.
PT PMA or local authorized representative
A foreign brand cannot hold the NIE directly, so it registers through one of two entities. Indonesia ties each registration to a single holder and the NIE cannot simply be transferred, so who holds it matters.
Set up a PT PMA
Your own foreign-owned company holds the NIE. You keep full control of registration and distribution, which suits a long-term presence or a portfolio of products. It carries the cost and upkeep of running a company.
Talk to our team about setting up your PT PMAAppoint a local representative
Emerhub acts as your independent product holder, holding the NIE on your behalf. It is the fastest way in without setting up a company. Because the holder is independent, not one of your distributors, you can change distributors without re-registering, and control stays with you.
Talk to our teamWhat has to be in place first
Once you know the class and who will hold the licence, the Ministry still will not review a product until the holder’s company licences exist and the manufacturer evidence is ready.
Set up the holding company
The holder needs, in order, an NIB business identity, an IDAK distribution licence, and a CDAKB good-distribution-practice certificate, mandatory since July 2024. All three must be in place before any product is registered, and one holder covers one brand.
Prove the manufacturer
An imported device (AKL) needs the manufacturer’s ISO 13485 certificate and a Certificate of Free Sale from the home market. A device made in Indonesia (AKD) needs CPAKB, the local good manufacturing practice certificate, mandatory since January 2024.
Prepare the dossier
On the imported route the manufacturer signs a Letter of Authorization naming the holder, legalized by the Indonesian Embassy and running at least two years. Everything goes into the ASEAN CSDT technical file, with labeling in Bahasa Indonesia.
The medical device registration process
With the class known and the holder licensed, we compile the dossier and run the filing.
Compile the CSDT dossier
- We prepare the ASEAN CSDT technical file: the ISO 13485 certificate, the risk file, and labeling in Bahasa Indonesia.
- We assemble the manufacturer evidence, the Certificate of Free Sale, and the Letter of Authorization for the holder.
Submit via Regalkes
- We file through the Regalkes portal under the holder’s licences, which it checks before accepting the dossier.
- We handle the review, including any correction rounds the Ministry raises.
Evaluation and NIE
- The Ministry evaluates the dossier and, on approval, issues the NIE, an AKL or AKD number.
- It runs for up to five years and is renewable. We track the dates and manage renewals.
How long registration takes
The Ministry works to an evaluation clock set by the risk class. That clock is only part of the story: total time runs longer because the holder’s licences and the CSDT dossier must be ready before it starts, correction rounds pause it, and Permenkes 11/2025 lengthened the review windows.
| Class | Official evaluation target | Realistic end to end |
|---|---|---|
| Class A | 16 to 21 working days | 1 to 3 months |
| Class B | 26 to 36 working days | 3 to 6 months |
| Class C | 26 to 36 working days | 6 to 12 months |
| Class D | 40 to 55 working days | 12 to 24+ months |
The evaluation target is the Ministry review clock, from domestic to imported. End-to-end ranges are realistic planning estimates that include holder setup and dossier preparation.
Halal, renewals, and staying compliant
An NIE runs for five years and is renewed before it expires. The holder is also responsible for post-market duties: keeping Bahasa Indonesia labeling in order, distribution reporting, and adverse-event reporting.
Medical device registration questions
What manufacturers and distributors ask most.
What is the difference between AKL and AKD?
AKL is the NIE code for an imported device, AKD for one made in Indonesia. The route is the same, but an imported device proves its factory with ISO 13485 and a Certificate of Free Sale, a domestic one uses the local CPAKB certificate, and only the imported route needs a Letter of Authorization.
What is the difference between IDAK and NIE?
IDAK is the company licence: it lets an Indonesian entity import and distribute medical devices. The NIE is the product registration, a marketing authorization issued for each individual device. A company needs a valid IDAK and a CDAKB certificate before it can apply for any NIE.
Can a foreign company register a medical device directly?
No. A foreign manufacturer cannot hold an Indonesian NIE. You register through your own PT PMA, which your company owns, or through a local authorized representative that holds the NIE on your behalf. We can set up either route and act as your holder where needed.
What has to be in place before a product can be registered?
The holder needs an NIB business identity, an IDAK distribution licence, and a CDAKB good-distribution-practice certificate, all before any product is filed. Then the product dossier is assembled: ISO 13485 and a Certificate of Free Sale for imported devices, or CPAKB for domestic ones, a Letter of Authorization on the imported route, and the CSDT technical file with Bahasa Indonesia labeling.
How long does registration take?
The Ministry evaluation runs on a working-day clock set by class, but total time is longer. Realistically, plan for about one to three months for a Class A device, three to six for Class B, six to twelve for Class C, and twelve to twenty-four or more for Class D, because the holder licences and the dossier must be ready before the clock starts and correction rounds pause it.
Is there a faster route for low-risk devices?
A short list of Class A device types that are home-use, non-sterile, and not IVDs can take a notification route rather than full registration. Most devices do not qualify, so we confirm eligibility before relying on it.
Do in-vitro diagnostics follow the same process?
Yes. IVDs register through the same Regalkes route under the same regulation, using the four-class risk scale with classification rules set specifically for diagnostics. The dossier and review depth scale with the risk class, as they do for other devices.
Is halal certification mandatory for medical devices?
It is being phased in by class. Class A must comply by 17 October 2026, Class B by October 2029, Class C by October 2034, and Class D by 2039. Until a device is certified, one containing animal-derived materials must carry a non-halal label.
What if the device or its details change after registration?
Changes to a registered device, such as a new manufacturing site, updated labeling, or a change of holder, are filed as a variation to the NIE. We assess whether a change needs a variation or a fresh registration and handle the filing.
How do I sell to government hospitals?
Public hospitals and government buyers purchase through the LKPP e-Katalog. Listing a device there is a separate step after the NIE, and local-content (TKDN) status can strengthen a listing. We advise on the route once your NIE is in place.
What if I want to move the NIE to a new distributor?
The NIE is tied to a single holder and cannot simply be transferred, so the choice of holder matters. If your NIE sits with a distributor, moving to a new one means cancelling and re-registering. If it sits with an independent holder, such as Emerhub acting as your representative, you can change distributors without touching the NIE.
Talk to our Indonesia team
Tell us the device, its risk class if you know it, and where it is manufactured. Our Jakarta team will put the IDAK/CDAKB-licensed holder in place, prepare the CSDT dossier, and run the Regalkes filing through to your NIE.
RT.7/RW.2, Kuningan
Jakarta 12950, Indonesia