Regulatory Authorities and Legal Foundations

Indonesia’s medical devices and in vitro diagnostics (IVDs) are regulated by the Indonesian Ministry of Health (MoH), specifically its Directorate General of Pharmaceutical and Medical Devices. Registration and licensing are required for all imported or domestically manufactured medical devices before they are introduced to the market.

Since 2018, Indonesia has aligned with the ASEAN Medical Device Directive (AMDD) and mandates the use of the ASEAN Common Submission Dossier Template (CSDT) when applying for product registration.

Who Can Apply & Business Licensing Requirements

Only a legally established Indonesian company can hold a medical device distributor license (formerly IPAK, now IDAK/MDDL). Foreign manufacturers must thus either:

Set up an Indonesian subsidiary with an investment threshold (e.g.,> IDR 10 billion, which is around USD 611,000).
Appoint an accredited local Authorized Representative or distributor who already holds an IDAK/MDDL.

Distributors must also hold a permanent business license under KBLI 46691, which covers the wholesale trade of medical devices.

The IDAK license, issued via Indonesia’s Online Single Submission (OSS) system, is valid for five years. As of July 2024, all medical device distributors must hold a GDPMD/CDAKB certificate (Good Distribution Practice Certificate) before obtaining an IDAK, and this has become mandatory for inclusion in the e-Catalogue for public procurements.

Classification & Documentation Required

Medical devices in Indonesia are categorized from Class A (lowest risk) to Class D (highest risk). Practically, registration for higher-risk devices takes longer, due to dossier complexity and clinical data requirements.

Registration applications submitted through the OSS system must include:

Company documents (IDAK license, authorization letter, etc.)
Technical dossier per ASEAN CSDT: device description, intended use, specifications, risk analysis, manufacturing details, etc.
Proof of quality system compliance: ISO 13485 certificate for imports; CPAKB certificate for local manufacturing
Labeling, instructions for use, warnings, and precautions in the Indonesian language (foreign languages allowed only when no Indonesian equivalent).
Test results (e.g., CoA, stability, sterilization/electrical safety), preclinical or clinical data, particularly for higher‑risk classes.

Post‑Marketing Obligations

Once registered, manufacturers and distributors must support post-market surveillance, including:

Adverse events reporting,
Field Safety Corrective Actions,
Complaint management,
Routine inspections by authorities and maintenance of device quality.

Independent healthcare facilities must also comply with MOH Regulation No. 15/2023, which mandates preventive and corrective device maintenance, allocating at least 4% of device asset value annually, with records maintained and reported semi‑annually.

Digital Systems and Catalogue Integration

All device license‑holders must enter their products into the Kamus Farmasi dan Alat Kesehatan (KFA) system, which assigns unique product codes for integration with Indonesia’s Satu Sehat digital health ecosystem. From January 2025, e-Catalogue Version 6 requires all products to have a KFA code that matches the MoH and OSS systems.

Step‑by‑Step Registration Workflow

Appoint a legal entity: either establish a subsidiary or appoint a licensed local distributor/AR holding IDAK and GDPMD.
Prepare dossier: Assemble administrative, technical, clinical data (if required), and labeling (in Indonesian).
Submit via OSS: Log into the OSS RBA system, upload documents, and pay fees.
Regulatory review: The evaluation period depends on the device class.
Receive product license: E‑license valid for up to 5 years
Input into the KFA system and e‑Catalogue: Register the KFA product code to enable public procurement access.
Post‑registration surveillance: Report adverse events, manage complaints, and comply with facility maintenance requirements.

Recent Regulatory Update

In July 2025, Indonesia enacted Government Regulation No. 28 (GR 28), expanding upon the earlier Health Omnibus Law with more detailed provisions on digital health, hospital governance, and biobanking.

Key updates include:

AI and robotic devices are now officially recognized in the National Health Information System (NHIS), allowing their data to be integrated into national health records.
Electronic medical receipts can be used for diagnosis and treatment, provided they are recorded in the NHIS.
Telemedicine is permitted via apps in hospitals, clinics, and pharmacies.
New criteria were introduced to assess the value of healthcare technologies for treatment, diagnosis, and prevention.
Biobank operators must now obtain permits, and all biological specimens must be stored within Indonesia.

A medical ethics panel will be established to support the Indonesian Health Council in improving healthcare professional standards.
Hospitals face stricter management requirements, and educational hospitals are now categorized into leading and satellite institutions, each with distinct roles.

GR 28 reflects Indonesia’s push to modernize healthcare regulation and expand digital health capabilities while reinforcing oversight and ethical standards.

Strategic Considerations for Manufacturers

Local presence: To comply with distribution licensing rules, international manufacturers almost always require a local partner or an in-country entity.
Time planning: The approval timeline depends heavily on device class and dossier completeness; begin preparing early.
GDPMD and CPAKB: These are now prerequisites for licensing; skipping them may cause applications to stall.
Digital readiness: Ensure seamless integration with OSS and KFA systems and stay alert for Ministry system outages.
Labeling and language compliance: Indonesian-language materials are mandatory, and non-compliant labels may delay registration.

Conclusion

Indonesia has streamlined its regulatory framework through ASEAN alignment, digital licensing via OSS, and the implementation of mandatory standards, including GDPMD/CDAKB and the KFA product code system. While regulations are clearer than before, successful device registration still requires careful planning: appointing a local entity, preparing a complete CSDT dossier, securing quality and distribution certifications, and ensuring post-market compliance. With these elements in place, medical device entry into Indonesia’s healthcare system becomes achievable and efficient.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)

Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.