Indonesia regulates medical devices and other products through agencies like the Ministry of Health (MoH) and BPOM. All products (e.g. medical devices, cosmetics, foods) require approval before sale. The MoH uses an online portal (Regalkes) for medical devices and issues a Nomor Izin Edar (NIE) as the market license[1]. Key steps include: classifying the product, preparing documentation (often using the ASEAN Common Submission Dossier Template), applying online, and meeting post-market obligations. 

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How to Classify Medical Device

Indonesia classifies products by type and risk. Medical devices are divided into four risk classes: Class A (low risk), B (low–moderate), C (moderate–high), and D (high)[3]. The device’s class determines required review depth. For example, Class A devices (like simple bandages or gloves) need minimal review, while Class D (e.g. implantables) require full clinical documentation[3]. Other categories (cosmetics, food, etc.) have their own BPOM categories, but the general principle is the higher the risk, the more stringent the documentation.

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Pathway of Registration

·         Local Representation: A local Indonesian entity must hold the product license. The foreign manufacturer typically appoints an Indonesian importer or uses a license-holder service[4]. Licenses required include an import license (IPAK) and distributor license (IDAK).

·         Company Setup: Foreign companies often use Indonesia’s OSS system to obtain a Business Identification Number (NIB) and necessary trade permits before applying.

·         Submission: The local entity submits an application in the MoH’s e-registration system (Regalkes)[5]. Required materials include the product dossier, labeling, and legal documents (below).

·         Evaluation: The MoH reviews documents and may request clarifications. Lower-risk products undergo basic checks; higher-risk ones have in-depth review.

·         Approval: If successful, the MoH issues the NIE (import license number) under the format KEMENKES RI AKL... for imported devices[1]. (Domestic devices use AKD). Once issued, the product can be marketed. The NIE holder (a local company) controls the product’s regulatory status[6].

 

Technical Documentation (ASEAN CSDT and Indonesian Differences)

Indonesia follows the ASEAN Medical Device Directive, using the ASEAN Common Submission Dossier Template (CSDT) for technical files[7]. Core elements include a Device Master File, risk analysis, clinical evaluation (for higher classes), manufacturing info and test reports[8]. These requirements align with other ASEAN countries. However, Indonesia has local twists:

·         Local Language & Legalization: All dossiers (labels, IFUs, LoA, Free Sale Certificates, GMP/ISO certificates) must be in Bahasa Indonesia or legally translated. Foreign documents (e.g. CE or FDA approvals) must be notarized/apostilled by an Indonesian embassy[9].

·         Regalkes Templates: The MoH’s Regalkes platform enforces Indonesian-language templates and strict file naming conventions, so documents must follow MoH formatting[9][10].

·         Distributor Requirements: The technical file should reference the local distributor’s licenses. The local partner must hold an IDAK (distribution permit) and a CDAKB (Good Distribution Practice certificate)[11].

Despite any CE-mark or FDA clearance, Indonesia requires a full local dossier. CE/FDA approvals or ISO 13485 certificates can support the dossier but do not replace local review[7][12].

 

Home-Country Requirements & International Certificates

Key documents from the product’s origin are required: a Letter of Authorization (LoA) from the foreign manufacturer to the Indonesian representative (legalized and covering the full term of registration)[11], and a Certificate of Free Sale (CFS/FSC) from the home country certifying the product is marketable there[12]. The manufacturer’s quality certificate (ISO 13485 or GMP) must be included[12]. Clinical data or safety studies conducted overseas can strengthen the submission. Any US/EU regulatory approvals (e.g. CE mark) must still be translated and adapted to Indonesian norms[9]. In short, Indonesia leverages foreign certifications as evidence but requires meeting its specific legal and language requirements[9][12].

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Timeline and Cost

Indonesia’s review times and government fees vary by class. The table below summarizes typical timelines and fees (in Euros, approximate) for medical device registration

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Class A 15 day, approx 105 EUR

Class B and C, 30 days, approx 210 EUR

Class D 45 days, approx. 315 EUR