Indonesia Kemenkes Medical Device Registration

Navigate Indonesia's Kemenkes regulatory framework with confidence. NexorTest Technologies provides end-to-end medical device registration consulting — from device classification and local representative appointment through REGALKES portal submission and Izin Edar (AKL) acquisition — for Class A through Class D devices, IVDs, and SaMD.

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Kemenkes Classification Pathways

Four Risk-Based Device Classes Under ASEAN AMDD

Indonesia classifies all medical devices into four risk categories aligned with ASEAN AMDD. Your device class determines the evaluation pathway, documentation requirements, and review timeline.

Class A — Risiko Rendah

Class A Devices (Low Risk)

Lowest-risk devices including band-aids, examination gloves, tongue depressors, and wheelchairs. Simplified notification pathway with minimal technical review through the REGALKES portal.

How is Class A registration different?

Simplified notification with minimal technical review, but realistic timeline is 3-6 months including administrative processing, PNBP fee management, and REGALKES portal queue times. PNBP fee: ~IDR 1.5M (~USD 95).

Class B — Risiko Rendah Menengah

Class B Devices (Low-Moderate Risk)

Low-moderate risk devices such as blood pressure monitors, thermometers, hearing aids, and surgical sutures. Requires full pre-market evaluation with ASEAN CSDT dossier submission.

What is needed for Class B evaluation?

Full pre-market evaluation with ASEAN CSDT dossier. Essential Principles of Safety and Performance, risk analysis, and biocompatibility data required. PNBP fee: ~IDR 3M (~USD 190).

Class C — Risiko Tinggi Menengah

Class C Devices (Moderate-High Risk)

Moderate-high risk devices including ventilators, bone fixation plates, hemodialysis equipment, and some implants. Detailed technical evaluation with clinical evidence requirements.

Is clinical data required for Class C?

Detailed technical evaluation with clinical evidence required. Local SNI testing at KAN-accredited labs may be needed. PNBP fee: ~IDR 3M (~USD 190). Permenkes 11/2025 extended evaluation timelines.

Class D — Risiko Tinggi

Class D Devices (Highest Risk)

Highest-risk devices including heart valves, hip implants, pacemakers, and HIV test kits. Subject to the most rigorous Kemenkes review with potential local clinical validation requirements.

Do Class D devices need local validation?

Most rigorous review pathway. Local clinical validation may be required for novel high-risk devices on the Indonesian population. PNBP fee: ~IDR 5M (~USD 315). Renewal: ~IDR 1M (~USD 63).

Our Indonesia Services

Comprehensive Kemenkes Registration Services

From initial classification through post-market surveillance, NexorTest manages every aspect of your Indonesia regulatory journey.

Kemenkes Device Registration

End-to-end Izin Edar (AKL) acquisition via the REGALKES portal. Complete dossier preparation per ASEAN CSDT template, PNBP fee management, and Kemenkes technical review navigation for Class A through Class D devices.

REGALKES Portal Management

Expert navigation of Indonesia's e-registration system at regalkes.kemkes.go.id. Application submission, document upload management, query response coordination, status tracking, and PNBP payment within the 7-day window.

Local Authorized Representative (LAR)

Appointment of an Indonesian Local Authorized Representative with valid IDAK licence. Your LAR holds the product license (Izin Edar) and handles all regulatory submissions, queries, and post-market obligations on your behalf.

CDAKB & IDAK Licensing

Good Distribution Practice (CDAKB) certification, mandatory since July 2024, and IDAK distribution license acquisition via OSS (Online Single Submission). Ministry of Health facility audit coordination and NIB registration support.

ASEAN CSDT Dossier Preparation

Complete Common Submission Dossier Template preparation per Indonesia's ASEAN AMDD guidelines. Essential Principles of Safety and Performance, risk analysis (ISO 14971), clinical evidence compilation, and labeling documentation.

ISO 13485 & SNI Compliance

QMS implementation (ISO 13485) and Indonesian National Standard (SNI) testing coordination at KAN-accredited laboratories. Gap analysis, documentation development, internal audit support, and certification body coordination.

Clinical Evaluation & Local Validation

Clinical evidence preparation aligned with ASEAN CSDT requirements. Local clinical evaluation support for novel high-risk devices requiring validation on the Indonesian population, literature reviews, and equivalent device comparisons.

IVD Registration Indonesia

Specialized In Vitro Diagnostic device registration covering IVD classification (Class A-D, ASEAN aligned), performance evaluation data compilation, local validation coordination for high-risk IVDs, and REGALKES submission management.

Halal Certification & Labeling

Halal compliance via BPJPH/MUI for devices with animal-derived materials. Phased timeline management (Class A by Oct 2026 through Class D by 2039). Bahasa Indonesia labeling translation, e-labeling compliance, and 4-year Halal certificate renewals.

Why NexorTest

Your Trusted Indonesia Regulatory Specialist

We combine deep local Kemenkes expertise with ASEAN-wide regulatory experience to deliver faster, more predictable Izin Edar approvals.

Indonesia & ASEAN Regulatory Specialists

Deep expertise in the Kemenkes framework, Permenkes regulations, and ASEAN AMDD requirements. Navigate Indonesia's unique requirements including CDAKB certification, SNI testing, Halal compliance, and Bahasa Indonesia labeling.

Local Representative Network

Established LAR partnerships in Indonesia with valid IDAK licences, CDAKB certification, and warehouse facilities ready for immediate appointment. No delays finding a qualified local partner.

REGALKES & OSS Portal Expertise

Experienced with both REGALKES (device registration) and OSS (business licensing) systems. Navigate PNBP fee management, document upload requirements, and administrative processing with confidence.

Multi-Region Expertise

Simultaneous registrations across Kemenkes, MDA Malaysia, HSA Singapore, CDSCO India, US FDA, EU MDR, and 30+ markets. One partner for global market access from a single integrated program.

Transparent Pricing & Fixed-Fee Packages

No hidden costs or hourly billing surprises. Our fixed-fee packages cover the complete scope from strategy through marketing authorization, with clear milestones and deliverables at every stage.

First Submission Acceptance

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Countries Served

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Faster Than Industry Average

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Our Process

Six Steps to Your Izin Edar (AKL)

A proven, structured approach that minimises review queries and accelerates your path to the Indonesian medical device market.

Device Classification & Regulatory Strategy

We classify your device per ASEAN AMDD rules (Class A, B, C, or D) and develop a tailored regulatory strategy. This includes determining documentation requirements, local SNI testing needs, Halal obligations, and a realistic timeline for Izin Edar acquisition.

LAR Appointment & CDAKB/IDAK

We appoint an Indonesian Local Authorized Representative (LAR) with valid IDAK distribution licence. We ensure CDAKB (Good Distribution Practice) certification is current and OSS/NIB business registration is in place before initiating any product submission.

ASEAN CSDT Dossier & Bahasa Indonesia Labeling

Our team prepares the complete dossier per the ASEAN Common Submission Dossier Template (CSDT). We translate all essential labeling and Instructions for Use (IFU) to Bahasa Indonesia and assign appropriate GMDN codes for device identification.

REGALKES Submission & PNBP Payment

We submit the completed application via the REGALKES portal at regalkes.kemkes.go.id. PNBP (Non-Tax State Revenue) fees are paid within the mandatory 7-day payment window. Administrative completeness review follows submission.

Kemenkes Technical Evaluation & Local Testing

We navigate the pre-market evaluation process at Kemenkes Ditjen Farmalkes. If required, we coordinate SNI testing at KAN-accredited laboratories. Technical queries are responded to within 10-15 working days to maintain review momentum.

Izin Edar (AKL) Issuance & Post-Market Compliance

Upon approval, we secure your 5-year Izin Edar (AKL) licence. We establish post-market surveillance with biennial laboratory testing at accredited labs, E-Report/E-Watch vigilance reporting, and Halal compliance tracking per the phased timeline.

Industries We Serve

Kemenkes Registration Across All Device Sectors

NexorTest supports medical device manufacturers across every therapeutic area and technology vertical entering the Indonesian market.

🏥 Cardiovascular Devices
🦴 Orthopaedic Implants
🔬 In Vitro Diagnostics (IVD)
💻 Software as Medical Device (SaMD)
🧬 Dental Devices
👁 Ophthalmic Devices
🩺 Patient Monitoring Systems
💉 Drug Delivery Devices
🧠 Neurological Devices
❤ Wound Care Products
🏋 Rehabilitation Equipment
💡 AI/ML-Based Medical Devices
🩸 Blood Bank Equipment
📊 Imaging & Radiology Devices
🧪 Laboratory Instruments
🛡 Sterilization Equipment

Frequently Asked Questions

Indonesia Kemenkes Registration FAQ

Expert answers to the most common questions about medical device registration with Kemenkes Indonesia.

What is Kemenkes medical device registration in Indonesia?

Kemenkes (Ministry of Health), not BPOM, regulates medical devices in Indonesia through the Directorate General of Pharmaceutical and Medical Devices (Ditjen Farmalkes). All medical devices manufactured in or imported into Indonesia must obtain an Izin Edar (Distribution License) with an AKL number via the REGALKES electronic registration portal at regalkes.kemkes.go.id. The regulatory framework is based on Permenkes No. 62/2017 (Distribution License) and PP No. 5/2021 (Medical Device Business Licensing). The Izin Edar is valid for 5 years and must be renewed before expiry.

What is the difference between BPOM and Kemenkes for medical devices?

BPOM (Badan Pengawas Obat dan Makanan) handles the regulation of drugs, traditional medicines, cosmetics, dietary supplements, and food products in Indonesia. Medical devices (alat kesehatan) are EXCLUSIVELY regulated by Kemenkes (Ministry of Health) through its Directorate General of Pharmaceutical and Medical Devices (Ditjen Farmalkes). There is no overlap between the two agencies regarding medical device regulation. All medical device registrations, distribution licenses (Izin Edar), and post-market surveillance are managed by Kemenkes via the REGALKES portal.

What is the REGALKES portal?

REGALKES (regalkes.kemkes.go.id) is the official electronic registration system operated by Kemenkes for all medical device submissions in Indonesia. All Izin Edar (Distribution License) applications, renewals, and variations must be submitted through this portal. The system handles document uploads, application tracking, query management, and status notifications. PNBP (Non-Tax State Revenue) fees are invoiced automatically through the portal, and payment must be completed within 7 days of invoice generation. Failure to pay within the window requires re-submission.

How are medical devices classified in Indonesia?

Indonesia classifies medical devices into four risk-based tiers aligned with the ASEAN AMDD (ASEAN Medical Device Directive) framework. Class A (Risiko Rendah) covers low-risk devices such as band-aids and tongue depressors. Class B (Risiko Rendah Menengah) covers low-moderate risk devices like blood pressure monitors and thermometers. Class C (Risiko Tinggi Menengah) covers moderate-high risk devices including ventilators and bone fixation plates. Class D (Risiko Tinggi) covers the highest-risk devices such as heart valves, hip implants, and pacemakers. Classification determines the evaluation pathway, documentation depth, and review timeline.

What is CDAKB and why is it mandatory?

CDAKB (Cara Distribusi Alat Kesehatan yang Baik) is the Indonesian Good Distribution Practice standard for medical devices. It has been mandatory since July 2024. CDAKB certification is required before any medical device product can be registered or distributed in Indonesia. The Ministry of Health audits distributor facilities to verify compliance with storage, handling, transportation, and traceability requirements. All Local Authorized Representatives (LARs) and distributors must hold valid CDAKB certification alongside their IDAK (Izin Distribusi Alat Kesehatan) distribution license.

How long does medical device registration take in Indonesia?

Registration timelines vary by device class. Class A (Risiko Rendah): ~15 working days official, but 3-6 months realistic including admin processing. Class B (Risiko Rendah Menengah): 45-60 working days official, 6-12 months realistic. Class C (Risiko Tinggi Menengah): 60-90 working days official, 9-18 months realistic. Class D (Risiko Tinggi): 90-120 working days official, 18-24+ months realistic. Permenkes No. 11/2025 has extended evaluation timelines. Actual duration depends on dossier completeness, query response speed, and local testing requirements. NexorTest’s expertise helps minimise delays.

Is Halal certification required for medical devices in Indonesia?

Halal certification follows a phased implementation schedule under PP No. 42/2024. Class A devices must be Halal certified by October 2026, Class B by 2029, Class C by 2034, and Class D by 2039. Non-Halal products are not banned from the market but must be clearly labeled as such. Halal certification is managed through BPJPH (Badan Penyelenggara Jaminan Produk Halal) with MUI (Majelis Ulama Indonesia) providing the fatwa assessment. Halal certificates are valid for 4 years. This primarily affects devices containing animal-derived materials such as porcine-origin collagen, gelatin, or bovine components.

Can NexorTest help with SaMD registration in Indonesia?

Yes, NexorTest provides specialized SaMD (Software as a Medical Device) registration services for Indonesia. SaMD is classified under the same Class A-D system aligned with ASEAN AMDD rules. An IEC 62304 certificate from an accredited laboratory is required for software lifecycle compliance. Additional requirements include software architecture documentation, cybersecurity risk assessments, clinical evaluation evidence, and intended use documentation. SaMD follows the same REGALKES submission pathway as hardware medical devices, with the ASEAN CSDT dossier template adapted for software-specific technical documentation.

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