接触

インドネシアにおける医療機器登録

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.

医療機器販売ライセンス (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.

適正流通基準証明書（CDAKB）

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

保健省への医療機器登録

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.

シームレスなコンプライアンスサポート

エンドツーエンドのサービス

当社は、ライセンスから製品登録までの規制の全過程を管理します。.

規制に関する専門知識

当社のチームは、深い知識と経験を組み合わせて、複雑な規制環境に対応します。.

スピードと効率

当社の実績ある戦略により、インドネシア市場における登録および承認のプロセスが加速されます。.

カスタマイズされたサポート

スムーズで安心できる旅を実現するために、個別のガイダンスと専用のサポートを提供します。.

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.

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市場参入支援

インドネシアに参入する国際メーカー向けに、IVD および医療製品の登録をサポートする柔軟な市場参入オプション。.

Initial Consultation

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

販売代理店の選択

当社は、規制および商業上の要件に準拠した適格な現地販売業者の特定と評価をお手伝いします。.

Export/Import Assistance

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

会社設立サポート

現地に拠点を設立する準備ができたら、インドネシアでの法令遵守を遵守した会社設立をお手伝いします。.

Initial Consultation

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

販売代理店の選択

当社は、規制および商業上の要件に準拠した適格な現地販売業者の特定と評価をお手伝いします。.

Export/Import Assistance

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

会社設立サポート

現地に拠点を設立する準備ができたら、インドネシアでの法令遵守を遵守した会社設立をお手伝いします。.

お問い合わせフォーム

弊社のチームは、お客様のビジネスニーズについてご相談に応じ、ご質問にもお答えいたします。お問い合わせフォームにご記入いただければ、1営業日以内にご返信いたします。.

お問い合わせフォーム
より迅速な対応と優先的な処理のために、会社のメールアドレスで送信してください。.

弊社に連絡するその他の方法。.

 よくある質問（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.

戦略的リーダーシップ
フセイン・H・マシュア博士（医学博士）

最高執行責任者（COO）であるフセイン・H・マシュア博士（医学博士）は、インドネシアの最も複雑な規制分野における製品登録およびライセンス取得において、10年以上にわたる献身的な実務経験を有しています。彼の戦略的な監督の下、当社の業務手順と顧客サービスは、実証済みの効率的なプロセスに基づいて構築されています。コンプライアンスとオペレーションの両方に精通した専門家リーダーならではの自信と明確さを持って、お客様の旅を始めましょう。.

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