Questions foreign health-tech companies actually ask

Does my medical device need approval before it can be sold in Indonesia?

Yes. Every medical device needs a marketing authorisation called Izin Edar, issued by the Ministry of Health and usually referred to by its number, the NIE. Under Permenkes 11/2025 — which implements PP 28/2025 on risk-based business licensing — Izin Edar is issued as a PB UMKU, a licence that supports a business activity, and is processed through the OSS system.

Can a foreign manufacturer hold the Indonesian licence directly?

No. For an imported device the Izin Edar is held by an Indonesian entity. That entity must already hold a Distributor Alat Kesehatan business licence (IDAK) and a Sertifikat Cara Distribusi yang Baik (CDB) for medical devices, and must have a letter of agency appointment from you as principal. You supply the supporting documents — a valid Certificate of Free Sale from the country of origin, a declaration of conformity, and quality-system evidence.

The practical consequence is easy to underestimate: choose your Indonesian partner before registration starts, because the licence is issued in their name, not yours.

What is IDAK?

IDAK — Izin Distribusi Alat Kesehatan — is the business licence permitting a company to distribute medical devices in Indonesia. Under Permenkes 11/2025 the licensed party is called a Distributor Alat Kesehatan. A company without IDAK cannot hold your product's Izin Edar.

What is CDB, and is it the same as CDAKB?

CDB — Cara Distribusi yang Baik, Good Distribution Practice — is the quality standard a device distributor must be certified against. Permenkes 11/2025 refers throughout to a Sertifikat Cara Distribusi yang Baik untuk Alat Kesehatan.

Older material commonly uses the abbreviation CDAKB. That term does not appear in the 2025 licensing standard. If a document you have been given still says CDAKB, it is worth checking which regulation it was written against — and whether the rest of it is equally out of date.

How is a medical device classified in Indonesia?

Indonesia uses risk classes A, B, C and D, aligned with the ASEAN Medical Device Directive. Class A is lowest risk, class D highest. The class drives how much technical evidence the dossier needs, how long review takes, and what post-market obligations follow approval.

How long does medical device registration take in Indonesia?

Permenkes 11/2025 sets maximum review periods. They are counted in working days — the regulation defines Hari as hari kerja, so 55 days is roughly eleven weeks, not eight.

For imported devices, renewal is at most 13 working days for every class, a change at most 16, a renewal combined with a change at most 16, and a notification-type registration at most 12.

One caveat that decides whether a launch date is realistic: these are the ministry's review clocks, not total project time. They start when a complete dossier is submitted, and they stop while a dossier sits with you for correction.

What happens if our dossier is returned for correction?

You may correct and resubmit at most twice, with up to 10 working days for each round — extended to 15 working days for class D.

What does renewing an Izin Edar require?

Renewal is reviewed within 13 working days for every class. For class C, class D, and class B in-vitro diagnostic reagents, the application must include a post-market surveillance report produced by the licence holder.

Where renewal is combined with changes, the licence holder must also have met the obligation to submit distribution reports electronically at least every six months beforehand. This one catches people out — it is a reporting record you either have or you don't, and it cannot be created retroactively at renewal time.

Does medical software need an Izin Edar in Indonesia?

Yes, if it has a medical purpose. Software — perangkat lunak — sits inside Indonesia's legal definition of a medical device in Permenkes 11/2025. Standalone medical software is therefore registered on the same pathway and in the same A–D risk classes as physical devices.

Indonesia regulates Software as a Medical Device within the general medical device framework rather than under a separate, dedicated SaMD regulation. The requirements are read across from the device rules, which is exactly why software companies are often unsure what applies to them.

Our product uses AI. Does that change the registration pathway?

The pathway is the same — an AI-enabled product with a medical purpose is classified and registered as a medical device. What changes is the evidence: how the model was validated, how it performs in the population it will actually be used on, and how it will be monitored and governed once deployed.

Indonesia's Ministry of Health also operates a health-technology regulatory sandbox, which runs alongside registration rather than replacing it.

What is the Kemenkes health technology regulatory sandbox?

A Ministry of Health programme that lets innovators trial health technologies in a controlled environment, with regulatory guidance and oversight, before full market launch. Publicly reported information indicates it has covered six clusters since 2024: medical education, medical diagnosis, patient solutions, online marketplace, telehealth, and wellness wearables and devices.

Plan it alongside the registration pathway, not as a substitute for it.

Can a device be imported before it is registered?

There is a special access pathway — pemasukan melalui jalur khusus — for defined situations such as specific patient need, research, or donation. It is a narrow exception with its own conditions and approvals, not a shortcut around registration. Eligibility should be confirmed against the current rules before any shipment is planned, because the conditions are specific and the consequences of getting them wrong land on the importer.

Do you act as our Indonesian licence holder?

No. PT Sehat Masa Depan is an advisory firm, not a distributor, and does not hold licences for client products. We help identify and qualify suitable Indonesian distributors, structure the agency arrangement, prepare and review the technical dossier, and manage the interaction with the Ministry of Health.

Keeping the adviser separate from the distributor is deliberate: it means our advice on which distributor to appoint is not advice about ourselves.

What should we prepare before engaging a regulatory adviser?

Most useful to have ready: the intended use statement, the product's classification in its home market, a valid Certificate of Free Sale, the quality management system certificate, the technical file or ASEAN CSDT dossier if one exists, and a realistic commercial target date.

One thing worth surfacing early: where a product's intended use is broader in other markets than what Indonesia will accept, that gap is far cheaper to find at the start than after a submission.