RegulatoryID

Indonesia's IDAK, NIE & IPAK System: A Complete Guide for Foreign Manufacturers

Mourad LahkimFounder, Nord Pacific Medical

·June 3, 20269 min read

MedMatchAi Insights

What IDAK distribution licences, NIE product registrations, and IPAK production permits mean in practice — and why understanding all three is essential before entering the Indonesian medical device market.

Indonesia's Three-Layer Regulatory Architecture

Indonesia's medical device regulatory framework is administered by Kemenkes(Kementerian Kesehatan — the Ministry of Health) and operates through three separate but interdependent licencing systems. Foreign manufacturers must understand how these layers interact before they can legally import or sell products.

IDAK — Distributor Licence. Izin Distribusi Alat Kesehatan. Grants a company the right to import, store, and distribute medical devices. Held by the distributor, not the manufacturer.
NIE — Product Registration. Nomor Izin Edar. A product-specific market authorisation. Required before a device can be offered for sale. Filed by the IDAK-holder on behalf of the manufacturer.
IPAK — Production Licence. Izin Produksi Alat Kesehatan. Required only for Indonesian domestic manufacturers. Foreign manufacturers are exempt but must hold valid GMP certification.
AKL / AKD — NIE Subtypes. AKL (Alat Kesehatan Luar Negeri) = imported device NIE. AKD (Alat Kesehatan Dalam Negeri) = domestically-made device NIE. The distinction matters for documentation requirements.

IDAK — The Distributor Licence

The IDAK is the foundational licence in Indonesia's medical device ecosystem. Without an active IDAK, no company can legally import or distribute medical devices in the country. As of 2025, there are 7,114 active IDAK holders across Indonesia, ranging from large national distributors to small regional specialists.

IDAK licences are granted by Kemenkes and are specific to: (a) the licence holder company, (b) their registered warehousing facilities, and (c) the product categories they are authorised to handle. This means a distributor cannot simply pivot into a new device category without amending their IDAK.

NIE — Product Registration (AKL vs AKD)

The NIE (Nomor Izin Edar) is a product-specific market authorisation number. Every medical device model sold in Indonesia must have its own NIE. A single distributor can hold hundreds of NIEs across multiple foreign principals. Indonesia's Kemenkes database currently contains 79,184 active NIE registrations.

Dimension	AKL — Imported Device	AKD — Domestic Device
Full Name	Alat Kesehatan Luar Negeri	Alat Kesehatan Dalam Negeri
Who Files	Indonesian IDAK distributor on behalf of foreign manufacturer	Indonesian IPAK manufacturer directly
GMP Required	Yes — ISO 13485 or equivalent from country of origin	Yes — Indonesian IPAK and domestic GMP standards
Technical Dossier	Declaration of Conformity, IFU, labelling, clinical evidence	Manufacturing records, local clinical data
Class B Timeline	60–120 days from complete submission	45–90 days (domestic queue priority)
Class C/D Timeline	6–18 months (full technical review)	4–12 months
Validity	5 years (renewable)	5 years (renewable)

NIE Registration Flow for Foreign Manufacturers

1. Select an IDAK-Licensed Distributor. The distributor will act as the legal entity filing the NIE application on your behalf. Verify their IDAK is active and covers your device category before proceeding.
2. Prepare the Technical Dossier. Compile: ISO 13485 GMP certificate (from your local regulatory authority), Declaration of Conformity, Instructions for Use (translated to Bahasa Indonesia), labelling compliant with Kemenkes requirements, and clinical/safety evidence appropriate for the device class.
3. Distributor Submits via Regalkes Portal.Your distributor submits the NIE application through Kemenkes' online portal (regalkes.kemkes.go.id). The application is filed under the distributor's IDAK account.
4. Kemenkes Technical Review. Kemenkes reviewers assess the technical dossier. For Class A/B devices, review is largely administrative. Class C/D devices undergo full clinical and safety evaluation and may require additional documentation requests (RFIs).
5. NIE Issued — AKL Number Assigned. On approval, Kemenkes issues the NIE number (AKL-XXXXXXXX format for imported devices). This number must appear on all Indonesian product labelling. The NIE is valid for 5 years from issue date.

IPAK — Who Actually Needs This?

The IPAK (Izin Produksi Alat Kesehatan — Production Licence) is required exclusively for companies manufacturing medical devices inside Indonesia. Foreign manufacturers exporting to Indonesia do not need an IPAK.

However, if a foreign manufacturer has a joint venture, contract manufacturing arrangement, or subsidiary in Indonesia that assembles or produces medical devices locally, that entity will require an IPAK before applying for AKD-type NIE registrations.

Common Mistakes Foreign Manufacturers Make

Avoid these pitfalls

Choosing a distributor without verifying their IDAK is active and covers the correct product category — an IDAK can be valid but not authorised for your device type.
Assuming NIE ownership by default. In Indonesia, NIEs are typically registered under the distributor's IDAK account. Without a contractual clause assigning ownership to you, transferring an NIE to a new distributor requires a formal application that can take 3–6 months.
Relying on AKD (domestic) registration timelines to estimate AKL timelines — imported devices consistently take longer, and the queues are separate.
Not translating all required documents to Bahasa Indonesia before submission. Kemenkes requires the IFU and labelling in Bahasa Indonesia — missing translations are the single most common cause of RFI delays.
Treating an IDAK check at onboarding as sufficient. IDAK licences require renewal, and distributors sometimes allow licences to lapse. Build a recurring check into your annual compliance calendar.

Quick-Reference Summary

IDAKHeld by Distributor

7,114Active IDAK holders

79,184Active NIE (AKL) registrations

IPAKOnly for Indonesian manufacturers

Licence	Who Holds / Files It	Key Detail
IDAK	Held by Distributor	7,114 active holders · Renewed periodically
NIE (AKL)	Filed by Distributor for Foreign Product	79,184 active · 5-year validity · GMDN-linked
IPAK	Only for Indonesian Manufacturers	Not required for foreign product exports

Frequently Asked Questions

What is an IDAK licence and why does my distributor need one?

An IDAK (Izin Distributor Alat Kesehatan)is the mandatory distributor licence issued by Indonesia's Ministry of Health (Kemenkes). Any company that distributes medical devices in Indonesia — whether importing, storing, or selling — must hold a valid IDAK.

For foreign manufacturers, the IDAK holder is your in-country partner. They are legally responsible for the product's post-market performance, recalls, and adverse event reporting. Without a distributor holding a current IDAK, your products cannot legally enter Indonesia's supply chain.

What is the difference between NIE, AKL, and AKD?

NIE (Nomor Izin Edar) is the product registration certificate required before a medical device can be marketed in Indonesia. It is issued by BPOM (for drugs) or Kemenkes (for medical devices).

Within the NIE system, AKL (Alat Kesehatan Luar Negeri) applies to imported devices — those manufactured outside Indonesia. AKD (Alat Kesehatan Dalam Negeri) applies to domestically manufactured products. As a foreign manufacturer, you will always apply for AKL, not AKD. The AKL number must be printed on the product label and packaging.

How long does NIE (AKL) registration take in Indonesia?

Official timelines from Kemenkes vary by risk class. Class A and B devices(lower risk) typically complete NIE registration in 3–6 months when documentation is complete. Class C and D devices(higher risk) routinely take 9–18 months, partly due to more stringent technical file review and the requirement for clinical data.

In practice, many applications take longer due to administrative back-and-forth or document deficiency letters (DIKH). Choosing a distributor with an experienced regulatory affairs team and an established relationship with Kemenkes significantly reduces timeline risk.

What is an IPAK and do foreign manufacturers need one?

IPAK (Izin Produksi Alat Kesehatan) is the production licence for manufacturers of medical devices in Indonesia. It is issued by Kemenkes and required for any entity that manufactures, assembles, or repackages medical devices within Indonesian territory.

Foreign manufacturers exporting to Indonesia do not need an IPAK. The IPAK requirement applies only to Indonesian domestic manufacturers. Your obligation as a foreign manufacturer is to appoint an IDAK-holding distributor and ensure your product obtains an AKL (NIE) registration through that distributor.

How do I verify that a distributor's IDAK is valid and active?

Kemenkes maintains a public registry called SIPERBEKKES (the health equipment and supplies information system) where you can search distributor licences by company name or IDAK number. Always verify directly on the official Kemenkes portal rather than relying solely on documents provided by the prospective distributor.

Key checks: confirm the IDAK is still within its validity period (IDAK licences have expiry dates), verify the business address matches official records, and confirm the distributor holds the correct sub-type of IDAK for your device category (some IDAK licences are category-restricted).

Find IDAK Distributors with Active NIE Portfolios

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