A Simple Guide to Medical Device Registration in Indonesia

Indonesia’s medical device registration is an important step for foreign manufacturers looking to enter the market. Every medical device sold, imported, or distributed in Indonesia must be registered with the Ministry of Health (Kemenkes) before it reaches the market. The process involves multiple sequential licenses, a technical dossier in ASEAN format, and ongoing post-market obligations.

This guide gives you a clear, step-by-step pathway to medical device registration in Indonesia. It covers the key regulators, required licenses, Distribution Permit (NIE) application, and ongoing compliance obligations, including KFA codes, SatuSehat integration, and Halal deadlines.

Whether you want to sell medical devices in Indonesia, appoint a local license holder, or understand what a medical device registration consultant does, this guide serves as a practical reference for 2026.

Who Regulates Medical Devices in Indonesia?

Medical devices (Alat Kesehatan) in Indonesia are regulated exclusively by the Ministry of Health (Kementerian Kesehatan / Kemenkes), through the Directorate General of Pharmaceuticals and Medical Devices (Ditjen Kefarmasian dan Alat Kesehatan). Registration, distributor licensing, and post-market surveillance all sit with Kemenkes.

The foundational legal definition of a medical device is set in Permenkes No. 62/2017 (Article 1). This definition is further refined by Permenkes No. 14/2021 (risk-based licensing standards) and consolidated under Permenkes No. 11/2025, which is the primary regulatory framework in force as of 2026. All product registration applications are submitted online at the Regalkes system.

Classification for Medical Devices in Indonesia: Classes A-D

Indonesia classifies medical devices into four risk classes under the ASEAN Medical Device Directive (AMDD). Your device’s class determines the required documentation, evaluation timeline, government fee (PNBP), and Halal compliance deadline. Identifying the correct class is the first decision in any medical device import into Indonesia or registration project.

Class	Risk Level	Examples	Clinical Test Requirements	Halal Deadline
Class A	Low	Cotton, bandages, gauze, walking canes, wheelchairs, adjustable beds	No	17 Oct 2026
Class B	Low–Moderate	Surgical masks, gloves, syringes, electric hospital beds, hemodialysis fluids	No (specific requirements apply)	17 Oct 2029
Class C	Moderate–High	X-ray machines, ECGs, monitoring systems, implants, pulse oximeters	No (risk analysis + safety data required)	17 Oct 2034
Class D	High	Heart valves, pacemakers, absorbable sutures, IVDs for blood-borne pathogens	Yes — clinical tests, published articles, risk analysis	~2039 (TBC)

If you are uncertain about your device’s class, InCorp Indonesia can issue a classification opinion based on your device’s intended use and risk profile before any license applications are filed. Talk to our team ->

Market Entry Routes Indonesia Medical Device Registration

Foreign manufacturers cannot register a medical device directly with Kemenkes. An Indonesian legal entity must hold all licenses. There are two routes:

Route	How It Works	Control over NIE	Best For
Establish a PT PMA	Set up a foreign-owned Indonesian company (IDAK + CDAKB + NIE held in your own name)	Full — you own the NIE	Long-term market presence; multi-distributor strategy; IP protection
Appoint a Local Authorized Representative (LAR) or distributor	Partner with an existing IDAK + CDAKB holder who registers the device on your behalf	Shared — LAR owns NIE during contract	Faster market entry; lower upfront cost; testing the market

Under the Positive Investment List (Presidential Regulation No. 49/2021), foreign investors may hold up to 100% ownership in the medical device distribution sector via PT PMA. The minimum paid-up capital for PT PMA is IDR 2.5 billion (BKPM Regulation No. 5/2025).

Required Licenses Before Registering Medical Devices in Indonesia

Before a NIE application can be submitted, the entity holding the registration must have three things in place. These are automatically checked by the Regalkes system — a missing license or a lapsed certificate will block submission.

Business Identification Number (NIB)

The NIB is issued through the Online Single Submission – Risk-Based Approach (OSS-RBA) platform and serves as the company’s legal operating identity. For medical device distributors, the relevant KBLI code is 46691. The NIB also functions as the basic import license, replacing the former TDP and API documents.

Medical Device Distributor License (IDAK)

The distributor license was previously called IPAK (Izin Penyalur Alat Kesehatan). Under PP No. 5/2021 and Permenkes No. 14/2021, it was renamed and restructured as IDAK (Izin Distributor Alat Kesehatan). In 2024, the Ministry of Health required existing IPAK holders to transition to IDAK. As of 2026, IDAK is the recognized license for medical device distributors in Indonesia, while IPAK is no longer used as the valid licensing reference.

Feature	IPAK (Old Regulations)	IDAK (Current Regulations)
Legal Basis	Permenkes No. 1191/2010 (repealed)	PP No. 5/2021 + Permenkes No. 14/2021
Validity	Indefinite	5 years — renewal required
Application	Manual / offline	Online via OSS-RBA
CDAKB Requirements	No	Yes — mandatory prerequisite
TRP Agreement	Not formalized	Notary Deed required (from Oct 2024)

Each IDAK holder must designate a Technical Responsible Person (TRP) for their device category. A Notary Deed of Cooperation Agreement between the company and TRP became mandatory from October 2024.

READ MORE:

• How US Manufacturers Can Import Medical Device Without Establishing a Company in Indonesia
• How to Register Medical Device in Indonesia
• Product Registration in Indonesia: How to Register Products via BPOM

Good Distribution Practice Certificate (CDAKB)

CDAKB (Cara Distribusi Alat Kesehatan yang Baik) is Indonesia’s good distribution practice standard for medical devices. It confirms that a distributor has the required facilities, systems, and procedures to handle medical devices properly, including temperature-controlled storage, qualified personnel, product traceability, and recall management.

Since 1 July 2024, CDAKB has been required before a company can submit a medical device Distribution Permit (NIE) application. It is also required for product listing on E-Katalog Version 6 from 1 January 2025.

Under Permenkes No. 11/2025, CDAKB compliance is now integrated into the OSS system. Without a valid CDAKB certificate, the NIB for KBLI 46691 cannot be used operationally.

Good Manufacturing Practice Certificate (CPAKB)

CPAKB (Cara Pembuatan Alat Kesehatan yang Baik) is mandatory from 1 January 2024 for any entity that both manufactures and distributes medical devices in Indonesia. For imported products manufactured overseas, the equivalent is the ISO 13485:2016 certificate from the overseas manufacturer.

Medical Device Registration Process in Indonesia: Step-by-Step

Once the NIB, IDAK, and CDAKB are in place, the NIE application is submitted through Regalkes. The required dossier follows the ASEAN Common Submission Dossier Template (CSDT), Indonesia’s harmonized format under the AMDD.

Required Documents

Document Category	Required Documents
Company Documents	NIB, Company Tax ID (NPWP), valid IDAK license, and valid CDAKB certificate
Administrative	Letter of Authorization (LoA) from the manufacturer, Free Sale Certificate (FSC), ISO 13485 certificate for imported products, or Ministry of Health Production License for locally manufactured products
Technical (CSDT)	Executive summary, Essential Principles checklist, device description, intended use, design verification and validation summary, pre-clinical or clinical evidence for Class C and D devices, ISO 14971 risk analysis, and manufacturer information
Labelling	Indonesian-language labels for the device and outer packaging, Instructions for Use (IFU) in Bahasa Indonesia, and e-labeling or QR code, where applicable, for professional-use devices under Permenkes No. 11/2025

Submission Steps

• Submit through Regalkes: Log in to the Regalkes system and start the NIE application. The system will check the company’s IDAK and CDAKB status.
• Upload Required Documents: Submit the CSDT dossier, administrative documents, technical files, and labeling documents in the required format.
• Pay the PNBP Fee: Pay the government evaluation fee based on the medical device class before the review begins.
• Wait for Kemenkes Evaluation: Evaluation time depends on the device class; it ranges from several weeks for Classes A and B to several months for Classes C and D.
• Receive NIE Approval: Once approved, the NIE is issued, and the product can be imported, distributed, and sold in Indonesia.

Notes: Kemenkes suspended its Regalkes platform from December 15, 2025, to January 9, 2026, for system upgrades in accordance with Permenkes No. 11/2025. Products whose NIEs expired during this window were considered lapsed from 1 January 2026. Plan all renewals at least 60 days before expiry.

READ MORE:

• Everything You Need to Know about Imported Household Product Registration in Indonesia
• CDAKB Certification Process: Essential Steps for Medical Device Distributors
• Lartas Indonesia: Restricted Product List & Import Licensing Requirements

NIE Requirements for Selling Medical Devices in Indonesia

The NIE is the market authorization number issued by Kemenkes. It is mandatory for any importation, sale, or distribution of a medical device in Indonesia. Distributing without a valid NIE is a regulatory violation under Health Law No. 17/2023, carrying penalties up to IDR 2 billion, product confiscation, and potential import bans.

Key rules governing the NIE:

• One NIE per Trade Name: Only one entity (distributor or importer) may hold the NIE for a given trade name/brand at a time, per Article 13, Permenkes No. 62/2017. Multiple registrations or transfers are not permitted outside a formal variation process.
• Validity: 5 years from issuance (or per LoA validity if shorter). Renewal must be initiated before expiry.
• Semi-Annual E-Report: NIE holders must file a distribution report every six months via Regalkes, covering product name, batch number, and expiry date.
• Labeling Compliance: In-market labels must match the approved submission exactly. Kemenkes conducts market sampling — buying products from shelves or inspecting hospital warehouses — to verify compliance.

If you need any assistance with compliance and legal proceedings, feel free to contact InCorp Indonesia.

Post-Market Obligations for Indonesia Medical Device Registration

Receiving a NIE does not end your regulatory obligations. Kemenkes enforces ongoing post-market compliance through the following mechanisms.

KFA Code Registration

All NIE holders must register their products in the Kamus Farmasi dan Alat Kesehatan (KFA) system, which assigns a unique standardized product code to each approved device. KFA codes are required for:

• E-Katalog Version 6: Mandatory from January 1, 2025. Products without a matching KFA code cannot appear in the catalog and are excluded from public hospital procurement.
• Satu Sehat: Indonesia’s national digital health platform. Healthcare facilities using Satu Sehat’s integrated electronic medical records must map all devices in their inventory to KFA codes, per Circular Letter No. HK.02.02/D/7093/2023. Without a KFA code, your product is invisible to hospital procurement systems.

Vigilance Reporting

Serious adverse events, device malfunctions, or near-misses must be reported to Kemenkes promptly. This obligation rests with the NIE holder, not directly with the overseas manufacturer.

CDAKB Surveillance Audits

The CDAKB certificate is not issued once. Kemenkes conducts periodic inspections to verify ongoing compliance with Good Distribution Practice standards. Audit failures result in CDAKB suspension, which automatically freezes the NIE.

Advertising Compliance

Promotional materials for medical devices may not exceed the approved indication claims recorded on the NIE. Advertising is monitored as part of Kemenkes post-market surveillance.

Need help after NIE approval? InCorp Indonesia can support your KFA registration, reporting, CDAKB compliance, and other post-market obligations to keep your medical devices ready for the Indonesian market. Talk to our team ->

Halal Compliance for Indonesia Medical Device Registration

Indonesia has introduced mandatory Halal certification for medical devices containing animal-derived materials (ADM), such as collagen, gelatin, heparin, and porcine components, under Presidential Regulation No. 6/2023, Permenkes No. 3/2024, and Government Regulation No. 42/2024. Certification is issued by BPJPH (Halal Product Assurance Organizing Agency). Foreign halal certificates issued by bodies with a Mutual Recognition Agreement with BPJPH are accepted in Indonesia after registration.

Devices made exclusively from non-animal-based materials are generally exempt, but must carry clear labeling stating this. Compliance is phased by device class:

• Class A (October 17, 2026): Deadline is imminent. Act now if your Class A device contains ADM.
• Class B (October 17, 2029): Begin ADM mapping and supplier assessment this year.
• Class C (October 17, 2034): Eight years. Plan early to avoid supply chain disruption.
• Class D (~2039 TBC): Deadline being finalized. Monitor BPJPH for implementing guidance.

Updates: On February 19, 2026, Indonesia and the United States signed the US-Indonesia Agreement on Reciprocal Trade (ART), which may exempt certain US-origin products from mandatory Halal certification. The specific scope for medical devices is still being defined through implementing regulations as of June 2026. Monitor BPJPH and the Indonesian Ministry of Trade for updates.

Register Your Medical Device in Indonesia with InCorp

To take advantage of the thriving opportunities in Indonesia’s healthcare sector and successfully register your medical products, InCorp Indonesia (an Ascentium Company) is ready to guide you through the complex process to ensure compliance with all regulations. We can assist you with:

• IDAK, CDAKB & NIE end-to-end management
• PT PMA setup for independent license holding
• ASEAN CSDT dossier preparation & review
• KFA code registration & Satu Sehat compliance
• Halal ADM audit & BPJPH certification support

Fill out the form below and tap into this underdeveloped market.

Frequently Asked Questions