Kontak

Registrasi Alat Kesehatan di Indonesia

From device classification to MoH approval, we manage every step of your Indonesian market entry. Our team handles the documentation, the regulatory submissions, and the in-country representation — so your product reaches market without delays.

Izin Penyalur Alat Kesehatan (IDAK)

We manage the full IDAK application process, ensuring your local distributor holds a valid distribution license under Ministry of Health requirements before product distribution begins.

Sertifikat Praktik Distribusi yang Baik (CDAKB)

We align your quality systems, SOPs, and facility documentation to meet CDAKB standards — a mandatory prerequisite for medical device distribution in Indonesia.

Pendaftaran Alat Kesehatan ke Kementerian Kesehatan

We handle product classification, technical dossier preparation, and end-to-end submission for all device risk classes through the Ministry of Health's Regalkes system.

Local Authorised Representative (LAR)

We act as your official in-country representative with the Ministry of Health — giving your products a compliant registration structure that stays independent from your distribution arrangements.

Why Medical Device Registration in Indonesia
Stalls Before It Starts

Most delays in Indonesian medical device registration come from the same three sources.
Understanding them upfront is the first step toward a faster, more predictable approval process.

01

Device classification does not map to CE or FDA risk classes

The Ministry of Health uses a four-class risk framework (Class A to D) that does not directly correspond to CE marking categories or FDA clearance pathways. Wrong classification means the wrong documentation — and rejections that set your timeline back by months.

02

Indonesia requires documentation your existing regulatory files do not cover

An Indonesian MoH dossier goes beyond a CE technical file or 510(k). Specific labeling requirements, Bahasa Indonesia translations, local quality system alignment, and IDAK prerequisites are mandatory — and missing any one of them is enough to trigger a clarification request or rejection.

03

Mandatory local representation can lock you into a single distributor

Indonesian regulations require product registrations to be held by a licensed local entity. Without a neutral licence holder structure, your product approval becomes tied to a single distributor — making it difficult to change commercial partners without losing your registration.

Dukungan Kepatuhan Tanpa Batas

Layanan Ujung ke Ujung

Kami mengelola seluruh jalur regulasi mulai dari perizinan hingga registrasi produk.

Keahlian Regulasi

Tim kami menggabungkan pengetahuan dan pengalaman mendalam untuk menavigasi lanskap regulasi yang kompleks.

Kecepatan dan Efisiensi

Strategi kami yang telah terbukti mempercepat proses pendaftaran dan persetujuan untuk pasar Indonesia.

Dukungan yang Disesuaikan

Memberikan panduan yang dipersonalisasi dan dukungan khusus untuk memastikan perjalanan yang lancar dan tanpa kekhawatiran.

End-to-End Medical Device Registration Support in Indonesia

Medical device registration in Indonesia is governed by the Ministry of Health through the Regalkes system and covers three mandatory requirements: a distribution license (IDAK), Good Distribution Practice compliance (CDAKB), and product registration approval (AKL/NIE). Every device — from Class A consumables to Class D implantables and IVDs — must be registered under a licensed local entity before it can be legally imported, marketed, or distributed in the Indonesian market.

Product Registration Indonesia provides a single, coordinated service framework that covers every step of the registration pathway. We begin with device classification and documentation scoping under MoH guidelines, align your technical files to Indonesian submission standards, and manage the full submission and follow-up process directly with the Ministry. For manufacturers that require in-country representation, we serve as your Local Authorised Representative — holding registrations on your behalf and maintaining your market access independently of any single distributor arrangement.

Pesan Konsultasi

Dukungan untuk Memasuki Pasar

Opsi masuk pasar yang fleksibel mendukung pendaftaran IVD dan produk medis bagi produsen internasional yang memasuki Indonesia.

Initial Consultation

Free for a 30-minute session with our regulatory experts. We’ll review your product scope and clarify the registration pathway.

Pemilihan Distributor

Kami membantu mengidentifikasi dan menilai distributor lokal yang memenuhi syarat dan sesuai dengan persyaratan regulasi dan komersial.

Export/Import Assistance

We manage customs clearance, import licensing, and regulatory documentation for entering the Indonesian market.

Dukungan Pendaftaran Perusahaan

Saat Anda siap untuk membangun kehadiran lokal, kami akan membantu pembentukan perusahaan yang sesuai dengan peraturan di Indonesia.

Initial Consultation

Free for a 30-minute session with our regulatory experts. We’ll review your product scope and clarify the registration pathway.

Pemilihan Distributor

Kami membantu mengidentifikasi dan menilai distributor lokal yang memenuhi syarat dan sesuai dengan persyaratan regulasi dan komersial.

Export/Import Assistance

We manage customs clearance, import licensing, and regulatory documentation for entering the Indonesian market.

Dukungan Pendaftaran Perusahaan

Saat Anda siap untuk membangun kehadiran lokal, kami akan membantu pembentukan perusahaan yang sesuai dengan peraturan di Indonesia.

Formulir Permintaan

Tim kami siap mendiskusikan kebutuhan bisnis Anda dan menjawab pertanyaan apa pun yang mungkin Anda miliki. Isi formulir pertanyaan kami, dan kami akan merespons dalam satu hari kerja.

Formulir Kontak
Kirimkan dengan email perusahaan Anda untuk respons yang lebih cepat dan penanganan prioritas.

Cara lain untuk menghubungi kami.

 Pertanyaan yang Sering Diajukan (FAQ)

Medical device registration in Indonesia requires a licensed distributor holding a valid IDAK (distribution license), Good Distribution Practice compliance (CDAKB), and a complete technical dossier submitted through the Ministry of Health’s Regalkes system. Specific documentation requirements vary by device risk class (A to D). All registrations must be held by a licensed local entity — foreign manufacturers without an Indonesian company can use a neutral Local Authorised Representative.
The Indonesian Ministry of Health classifies medical devices into four risk classes: Class A (lowest risk), Class B, Class C, and Class D (highest risk, including active implantables). Classification is determined by intended use, mode of action, and risk profile. It does not directly align with CE or FDA risk categories, which is one of the most common causes of incorrect documentation and submission delays. PRI conducts a classification review as part of every registration engagement.
IDAK (Izin Distribusi Alat Kesehatan) is the distribution license that authorises a company to import and distribute medical devices in Indonesia. CDAKB (Cara Distribusi Alat Kesehatan yang Baik) is the Good Distribution Practice certificate that confirms the distributor’s quality systems, SOPs, and warehouse facilities meet MoH standards. Both must be in place before a product registration submission can be accepted by the Ministry of Health.
Yes. Indonesian regulations require the registration to be held by a licensed local entity, but foreign manufacturers are not required to establish their own Indonesian company. PRI can act as your Local Authorised Representative (LAR), holding product registrations under a neutral, independent structure that keeps your market access separate from any distributor arrangement and fully transferable if your commercial strategy changes.
A Local Authorised Representative is a licensed Indonesian entity that holds the product registration (AKL/NIE) on behalf of a foreign manufacturer. As your LAR, PRI ensures your devices remain registered and compliant with MoH post-market obligations — without tying your approval to a distributor. This structure is particularly valuable for manufacturers who want commercial flexibility or plan to work with multiple distribution partners in Indonesia.
Typical requirements include a Letter of Authorization from the foreign manufacturer, Certificate of Free Sale from the country of origin, ISO 13485 certificate, technical and clinical documentation appropriate to the device class, labeling in Bahasa Indonesia, and quality system records. IVD devices may require additional performance and analytical validation data. PRI conducts a documentation gap analysis before submission to ensure all files are complete and aligned to MoH standards.
Medical devices distributed in Indonesia must carry labels in Bahasa Indonesia that include the device name, intended use, manufacturer details, registration number (AKL/NIE), warnings, contraindications, and storage or handling instructions relevant to the product. Labeling requirements are reviewed by the Ministry of Health as part of the registration dossier. Non-compliant labeling is a common cause of post-approval sanctions and market withdrawal actions.
In vitro diagnostic (IVD) devices follow the same Regalkes registration pathway as other medical devices but typically require additional performance evidence, analytical validation data, and reference range documentation. Classification criteria for IVDs are also specific to intended use and test category, which means the documentation scope can differ significantly from that of a comparable general medical device. PRI supports IVD registration across all device categories.
Registration timelines vary by device class. Class A and Class B devices generally have shorter review periods, while Class C and Class D devices — including IVDs — undergo more extensive evaluation and may take considerably longer. The primary driver of timeline overruns is incomplete or misaligned documentation. PRI’s pre-submission review and documentation gap analysis is designed to reduce clarification requests from the Ministry and keep the process on track.
Registration approval (AKL/NIE) is valid for a defined period and must be renewed before expiry. Post-market obligations include notifying the Ministry of Health of any significant changes to device specifications, labeling, manufacturing site, or distribution arrangements. Failure to maintain compliance can result in suspension or revocation of the registration. PRI provides ongoing post-market compliance support and manages renewal submissions to ensure your products remain in the Indonesian market without interruption.

Kepemimpinan Strategis dengan
Dr. Hussein H. Mashhour, MD

Sebagai Chief Operating Officer (COO) kami, Dr. Hussein H. Mashhour, MD, membawa lebih dari satu dekade pengalaman langsung yang berdedikasi dalam pendaftaran dan perizinan produk di berbagai sektor regulasi paling kompleks di Indonesia. Pengawasan strategisnya memastikan bahwa prosedur operasional dan layanan klien kami dibangun di atas proses yang terbukti efisien. Mulailah perjalanan Anda dengan keyakinan dan kejelasan yang hanya dapat diberikan oleh seorang pemimpin ahli di bidang kepatuhan dan operasional.

Pesan konsultasi gratis
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