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. We classify the device, put the licensed holder in place, and run the dossier through to your NIE.
How medical device registration works in Indonesia
The NIE is the marketing authorization for a single device. Each product registers under its own trade name and gets its own NIE, which means a catalog of ten devices needs ten separate registrations. How much evidence each one calls for depends on its risk class, from A to D.
One thing to settle early is who holds the registration, because a foreign manufacturer cannot hold it directly. Instead, you register through your own PT PMA or through a local holder. In both cases, that entity must already carry its company-level distribution licenses before the Ministry of Health (Kemenkes) will review a single product.
For the dossier itself, Indonesia follows the ASEAN Medical Device Directive. So the technical file uses the Common Submission Dossier Template (CSDT) and is filed through the Regalkes portal, under Health Minister Regulation 62 of 2017. In-vitro diagnostics follow the same route.
IDAK and NIE are not the same thing
These two are easy to mix up, since both involve distribution and both are issued by the Ministry of Health. The difference is the level. IDAK licenses the company, while the NIE registers the product.
IDAK, the company license
Izin Distribusi Alat Kesehatan is what lets an Indonesian company import, store, and distribute medical devices at all. It is granted to the entity rather than the product, and it comes with facility checks and a named Technical Responsible Person. You may also see it under its former name, IPAK.
NIE, the product registration
Nomor Izin Edar is the marketing authorization for one specific device, issued per product. It is what actually allows that device to be sold. Before a company can apply for any NIE, its IDAK and CDAKB must already be in place.
How devices are classified
Indonesia uses the four ASEAN risk classes. The class sets the documentation, the fees, and the review timeline.
| 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 |
In-vitro diagnostics use the same four-class scale, though under classification rules set specifically for IVDs. In either case, the higher the class, the fuller the evidence required, including clinical data, and the longer the review takes.
PT PMA or local authorized representative
As noted above, a foreign manufacturer registers through one of two entities. Whichever you choose, it still needs the company-level licenses covered below.
Set up a PT PMA
Your own foreign-owned company holds the NIE. This gives you full control over registration and distribution, which suits a long-term presence or a portfolio of several products. It also carries the cost and upkeep of running a company.
Appoint a representative
A local entity holds the NIE for you. This is the fastest way in without setting up your own company. Choosing an independent holder, rather than tying the NIE to one distributor, lets you keep control and change distributors freely.
What has to be in place first
The Ministry will not look at a product until the groundwork is done. That groundwork comes down to three things: the holder’s licenses, proof that the factory meets quality standards, and, on the representative route, the authorization that names you as the holder.
The holder’s IDAK and CDAKB
These come in sequence: IDAK first, then CDAKB, then product registration. IDAK licenses the company to distribute, while CDAKB, the good distribution practice certification, is a full audit that has been mandatory since July 2024 before any product can be registered. If either license lapses, every NIE the holder carries is frozen along with it.
Manufacturer compliance
The factory’s quality system has to be proven. An imported device needs the manufacturer’s ISO 13485 certificate and a Certificate of Free Sale from the home market. A device made in Indonesia needs CPAKB instead, the local good manufacturing practice certification.
Letter of Authorization
On the representative route, the manufacturer signs a notarized Letter of Authorization naming the holder and the exact products it covers. It should run for at least five years, so the NIE can keep its full term.
How we register your device
From classification to your NIE.
Step 1 — Classify the device
We determine the ASEAN risk class, from A to D, applying the IVD rules for diagnostics. The class sets the dossier and the depth of the review.
Step 2 — Put the holder in place
Your PT PMA or representative secures its IDAK and CDAKB, the company-level licenses that open access to the Regalkes portal.
Step 3 — Compile the CSDT dossier
We prepare the technical file on the ASEAN Common Submission Dossier Template, including the ISO 13485 certificate, the risk file, and labeling in Bahasa Indonesia that matches the submission.
Step 4 — Submit via Regalkes
We file under the holder’s licenses. Regalkes checks the IDAK and CDAKB status before it accepts the dossier.
Step 5 — Review and NIE
The Ministry evaluates the dossier and, on approval, issues the NIE. It runs for up to five years and is renewable.
Halal certification is being phased in for devices
Medical device registration questions
What manufacturers and distributors ask most.
What is the difference between IDAK and NIE?
IDAK is the company license: 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.
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, and Class C by October 2034, with the Class D deadline not yet set. Until a device is certified, one containing animal-derived materials must carry a non-halal label.
How is the Letter of Authorization handled?
For the representative route, the manufacturer signs a notarized Letter of Authorization naming the holder and the products it covers. We recommend a term of at least five years so the NIE can run its full validity. We prepare the document and manage the notarization.
What if I want to move the NIE to a new distributor?
This is where the choice of holder matters. If your NIE sits with a distributor, moving it means re-registering with the new one. If it sits with an independent holder, such as Emerhub acting as your representative, you can change distributors without touching the NIE.
How long is an NIE valid?
Up to five years, after which it is renewed. The Letter of Authorization should cover at least the same period so the registration can run its full term.
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