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Andi Refandi
Andi serves as a Senior Account Executive on Emerhub’s global team.
The government’s focus on modernizing hospital infrastructure (6 Pillars of Health Transformation) and digital health boom through SatuSehat had triggered a consistent demand for medical consumables and diagnostic tools in Indonesia. In 2025, the Indonesian medical device market was valued at approximately USD 2.37 billion and projected to grow by 9.1% by 2030.
If you’re planning to capitalize on the demand for medical devices in the country, you need to register your products with the Ministry of Health (Kemenkes). As a requirement, you need to adhere to the country’s labeling standards which can make or break your registration.
This guide serves as your comprehensive roadmap to understanding medical device labeling requirements in Indonesia. We will outline key regulations and a checklist of what your product labels should have.
Understanding Medical Device Registration in Indonesia
The primary authority in medical device registration is the Ministry of Health, specifically the Directorate of Medical Device Production and Distribution.
Recently, the regulatory environment has undergone a significant shift. While Permenkes No. 62 of 2017 provided the foundation for many years, the new Permenkes No. 11 of 2025 now serves as the overarching standard for health sector business activities. This new regulation streamlines the risk-based licensing system (OSS-RBA) and introduces more rigorous definitions for what constitutes a “compliant label.”
Furthermore, Indonesia is a lead signatory to the ASEAN Medical Device Directive (AMDD). This is good news for foreign-owned companies since the technical dossier format (CSDT) and risk classifications (Class A through D) are harmonized across Southeast Asia. However, Indonesia has its own specialized standards, particularly about language and Halal traceability.
What defines a “Label” in 2025?
Under Permenkes No. 11 of 2025 (Peraturan Menteri Kesehatan Nomor 11 Tahun 2025), labeling is defined as any objective, complete, and non-misleading information presented in the form of images, colors, text, or a combination thereof. This information can be:
- Physical: Attached to the outer packaging (box) or the immediate container (bottle/pouch).
- Electronic: Provided as a link or QR code that forms part of the product information.
- Internal: The Instructions for Use (IFU) or User Manual included inside the package.
- Fixed: Marking plates etched or attached directly to the hardware of the device itself.
Mandatory Labeling Requirements to Register your Medical Device in Indonesia
To legally import, distribute, and sell medical devices in Indonesia, you need to secure a Nomor Izin Edar (NIE) or Product Registration Number from Kemenkes. As a prerequisite, you need to adhere to the country’s strict labeling standards. Here is a checklist of what your medical device labels should have:
- Product Name: Both the trade/brand name and the generic or technical name must be present.
- Marketing Authorization Number (NIE): This is the “passport” number issued by Kemenkes (e.g., KEMENKES RI AKL XXXXXXXX). For imported products, it starts with AKL; for locally manufactured ones, it starts with AKD.
- Entity Details: You must list the name and full address of the manufacturer (Global HQ) AND the importer/distributor (Local Indonesian entity holding the license).
- Traceability Data: Lot number, batch number, or serial number. This is critical for post-market surveillance and recall management.
- Critical Dates: Both the Manufacturing date and the Expiration date must be clearly formatted (usually YYYY-MM-DD or MM-YYYY).
- Product Status: If the device is sterile, the label must state “STERILE” and identify the sterilization method used (e.g., EO, Gamma, or Steam).
- Intended Use: A concise statement of what the device is meant to do (e.g., “For blood glucose monitoring only”).
- Quantity/Packaging Contents: For example, “Contains 50 test strips” or “1 Unit.”
Language Requirements for Medical Device Labeling
All labels must be in Bahasa Indonesia. While the AMDD allows for English in many regional markets, the Indonesian Ministry of Health is uncompromising. All safety information, warnings, and primary instructions must be translated into the national language.
The Indonesian government views labeling as a matter of public safety. While specific technical engineering specifications or complex chemical formulas can sometimes remain in English, anything related to contraindications, side effects, or “how to use safely” must be clearly stated in Bahasa Indonesia.
Instructions for Use (IFU) & Manuals
The IFU is where most administrative “queries” (rejections) occur during the registration process. For Class B, C, and D devices, a comprehensive manual is mandatory.
Can we go digital? Yes, but there are caveats. Permenkes No. 11 of 2025 formally recognizes E-labeling.
- Professional Devices: For devices used exclusively by healthcare professionals (like an X-ray machine or a surgical robot), a QR code or a website link for the IFU is generally accepted.
- Home-Use Devices: For products sold directly to consumers (like blood pressure monitors or thermometers), a physical, printed manual in Bahasa Indonesia is still the “gold standard” to ensure patient safety. If you choose e-labeling for these, you must still provide basic safety inserts in the box.
Labeling for Specific Device Types
One of the key aspects to keep in mind is that not all medical devices require the same information on their labels. Depending on what you sell, you may need additional data:
- In Vitro Diagnostics (IVD): Labels must include specific storage temperatures (e.g., “Store between 2°C – 8°C”) and data on reagent stability after the vial is first opened.
- Electromedical Devices: You are required to use standard international symbols (IEC 60601-1) for electrical safety. Additionally, the device must have a physical “marking plate” showing the voltage, frequency, and serial number.
- Refurbished Devices: These products MUST be labeled as “Rekondisi” (Reconditioned) or “Remanufaktur” (Remanufactured). Selling a refurbished device without this specific label is considered consumer fraud and can lead to immediate license revocation.
New 2025 Halal Labeling Mandate
Indonesia is currently implementing one of the world’s most comprehensive Halal traceability systems. Under Government Regulation (GR) No. 42 of 2024, medical devices are now part of a mandatory, phased Halal labeling timeline. You don’t necessarily need a Halal logo today, but you must prepare for these deadlines:
- Class A (Low Risk) Devices: Must comply with Halal labeling/certification by October 17, 2026.
- Class B (Moderate Risk) Devices: Must comply by October 17, 2029.
- Class C (Moderate-to-High Risk) Devices: Must comply by October 17, 2034.
- Class D (High Risk) & Biological Products: Deadlines typically extend to 2039 to account for the complexity of the materials and production processes involved.
Kemenkes Post-Market Surveillance
The Ministry of Health does not stop watching once your NIE is issued. They conduct regular “market sampling” where they buy products off the shelf or visit hospital warehouses to check if the label in the field matches the one approved in the system.
If a discrepancy is found, the penalties are tiered:
- Level 1 (Administrative Warning): You receive a formal letter and are given 14–30 days to correct the labels.
- Level 2 (Suspension): Your NIE is temporarily frozen in the Regalkes system, meaning you cannot import or sell new stock.
- Level 3 (Revocation & Recall): The most severe penalty. Your license is canceled, and you must pay for the full recall of all products from every hospital and pharmacy in Indonesia.
Labeling is a crucial step in medical device registration. You must adhere to the ASEAN and Indonesian standards in language and halal labeling to enter the market. To expedite this process, Emerhub can help you register your medical products by acting as your Local Authorized Representative (LAR) with the required IDAK license.
We will handle full pre-market registration via the Regalkes portal to secure an NIE for your products. We ensure compliance with MoH standards like risk classification, technical dossiers, and ISO 13485 certification.
Talk to our local experts in product registration with a free consultation by filling out the form below.
FAQs About Medical Device Labeling Requirements in Indonesia
For many international manufacturers, printing a specific “Indonesian-only” box for a small initial shipment is not cost-effective. Kemenkes understands this and allows over-labeling (applying stickers over the original packaging).
However, these stickers must meet three criteria:
- Permanence: They cannot be easily peeled off or tampered with.
- No Obscuration: They must not cover the original manufacturer’s batch number, serial number, or expiry date. These must remain visible for cross-referencing.
- Controlled Application: You cannot apply these stickers in a retail shop or a standard office. They must be applied in a Bonded Warehouse or a facility certified with CDAKB (Good Distribution Practice for Medical Devices).
Under Permenkes No. 11 of 2025, Kemenkes formally recognizes e-labeling as a valid way to provide instructions, particularly for devices intended for professional use in clinical settings. However, for high-risk or home-use devices, essential safety information and the primary Instructions for Use (IFU) must still be provided in a physical format (such as a printed insert) in Bahasa Indonesia to ensure immediate access in emergencies.
Under the updated GR 42/2024, being “non-halal” does not bar your medical device from the Indonesian market. However, transparency is legally mandatory. If your product contains materials derived from prohibited sources (e.g., porcine/pig derivatives), you must clearly state this on the label using specific non-halal icons or text. This allows users to make informed decisions based on their religious or ethical requirements.
The NIE must, at a minimum, be printed on the smallest unit of primary packaging. For large hardware or electromedical equipment (such as an ultrasound machine), the NIE is typically etched or printed on the marking plate attached to the device. For small consumables (like a single test strip), the NIE must appear on the box or pouch that the user first opens.
Not necessarily. If you are making minor adjustments, such as updating your local distributor’s office address or tweaking the visual layout without changing the technical content, you can apply for a “Change Notification” (Perubahan) through the Regalkes system. This is a significantly faster and more cost-effective process than a full re-registration, which is usually reserved for changes in intended use or brand ownership.
Yes, Indonesia permits the use of English alongside Bahasa Indonesia, and many international brands prefer a bilingual approach. However, there is a “safety priority” rule: all warnings, contraindications, side effects, and primary usage instructions must be available in Bahasa Indonesia. If these are only in English, the label will be rejected during the Ministry of Health evaluation.
