Medical Device Registration in Indonesia

Medical devices in Indonesia are regulated by the Ministry of Health (Kementerian Kesehatan / Kemenkes), specifically through the Directorate General of Pharmaceuticals and Medical Devices (Ditjen Farmalkes).

All registration applications are submitted through the Regalkes system. The legal basis for medical device registration is Permenkes No. 62/2017, supplemented by Permenkes No. 14/2021 and the current consolidating regulation, Permenkes No. 11/2025.

Yes. Foreign manufacturers cannot register medical devices directly with Kemenkes. The registration must be held by an Indonesian legal entity with the required licenses.
Foreign companies can either establish a PT PMA to hold the IDAK and NIE under their own entity or appoint a licensed local representative or distributor to register the product on their behalf.

The NIE (Nomor Izin Edar) is the market authorization issued by Kemenkes. It is required before a medical device can be imported, distributed, or sold in Indonesia.

AKL refers to the NIE for imported medical devices, while AKD refers to the NIE for locally manufactured medical devices. Both are processed through Regalkes and follow similar post-market obligations.

The main difference is in the supporting documents. Imported products usually require documents from the overseas manufacturer, while local products require documents from the Indonesian manufacturer. An NIE is generally valid for five years and must be renewed before expiry.

Indonesia classifies medical devices into four risk-based classes under the ASEAN Medical Device Directive (AMDD). Class A: Low risk, Class B: Low to moderate risk, Class C: Moderate to high risk, and Class D: High risk. The device class affects the required documents, evaluation timeline, government fees, and Halal compliance deadline.

Getting the classification right before submission is important because it determines how the registration process should be prepared.

The required documents include company documents, manufacturer authorization, product certificates, technical files, risk and safety information, and Indonesian-language labeling.

For imported medical devices, documents from the overseas manufacturer are also required, such as the Letter of Authorization, Free Sale Certificate, and ISO 13485:2016 certificate.

The evaluation timeline depends on the medical device class and the readiness of the documents. In general, Class A may take around 3–6 weeks, Class B around 6–12 weeks, Class C around 3–6 months, and Class D around 6–12+ months.

These timelines cover only the evaluation stage. Companies should also factor in pre-registration steps, such as entity setup, IDAK application, and CDAKB certification.

The distribution license (IDAK) is a company-level license. It allows an Indonesian entity, such as a PT PMA or local distributor, to import and distribute medical devices. The medical device registration (NIE) is a product-level approval. It allows a specific medical device to be sold and distributed in Indonesia.

In simple terms, IDAK authorizes the company, while NIE authorizes the product. Both must remain valid for the product to be lawfully marketed in Indonesia.

CDAKB (Cara Distribusi Alat Kesehatan yang Baik) is Indonesia’s Good Distribution Practice certification for medical device distributors. It confirms that a distributor has the proper facilities, personnel, procedures, and traceability systems to handle medical devices safely.

Yes, CDAKB is required. It is needed before submitting a medical device NIE application and is also important for government procurement listing and ongoing OSS compliance.

It depends on who holds the NIE. If your distributor holds the NIE, the registration is linked to that distributor’s entity. Changing distributors may require a release process or a new registration.

If the NIE is held through your own PT PMA or a neutral local license holder, you have more control. You can change or appoint distributors without disrupting the product registration.

InCorp Indonesia can support license-holder structures that help foreign manufacturers keep greater control over their medical device registration and distribution strategy in Indonesia.

After the NIE is issued, the license holder must continue meeting post-market obligations. These include regular reporting through Regalkes, KFA code registration, CDAKB audit readiness, vigilance reporting, labeling compliance, Halal compliance where applicable, and NIE renewal before expiry.

In simple terms, approval is not the end of the process. The NIE holder must keep the product, license, and distribution activities compliant throughout the product’s market life in Indonesia.

InCorp Indonesia can support post-approval management, including reporting, KFA registration, renewal coordination, and CDAKB compliance support.

Yes. InCorp Indonesia can support the full medical device market entry process, from entity setup and IDAK application to CDAKB certification, NIE registration, and post-market compliance.

Our team can also assist with local license-holder structures, Regalkes submission, KFA registration, NIE renewal, Halal coordination, and import-related support where required.