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January 16, 2025
Approximately 5 minutes
Medical device labeling in Indonesia is strictly regulated by the Ministry of Health (MoH) to ensure user safety and compliance. For foreign manufacturers, ensuring accurate translation and inclusion of all required elements is critical for domestic distribution.
The fundamental requirement for medical device labeling in Indonesia is the use of the local language for key safety and usage information:
Every medical device label or accompanying documentation must contain the following information:
The responsibility for ensuring local labeling compliance falls on the local entity that holds the marketing license (Independent License Holder or licensed distributor).
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ElendiLabs
法规底线： 虽然印尼正向数字化转型，但 2026 年的规定依然明确：物理说明书还是需要。纸质内容： 对于所有器械，包装内必须附带至少包含以下内容的纸质说明书（Bahasa Indonesia）： • 操作说明与预期用途； • 禁忌症、警告(Peringatan)及副作用(Efek Samping)； • NIE 注册号和本地代理商 (IDAK) 信息。QR 码角色： QR 码被视为“增值信息”，可用于提供更详细的视频教学或多语言版本。如果完全缺少纸质版，产品有机会在清关环节因“标签不完整”被扣押。
timothylai
We have an IVD platform where multiple reagent kits share the same 'Universal Buffer' solution. In the 2026 Regalkes registration, do we need a separate NIE number and a unique Indonesian label for each individual bottle, or can we use a 'System/Bundle Label'? How does the MoH view the expiration date labeling if the buffer and the active reagent have different shelf lives?
ElendiLabs
Bundling Rules: If registered as a System/Kit, you might use a primary label for the entire box. However, each individual component inside must at least have a label indicating its Lot Number, Expiry Date, and Product Code.Expiry Date Management: It is suggested that the outer box label display the earliest expiration date of any component within the kit. You should not display the date of the longest-lasting component. During MoH audits, if they find an expired buffer inside a kit that is technically still 'valid' according to the outer box, it could be flagged as a critical non-compliance leading to a potential recall.
Tomlee
Our Class C orthopedic implants contain porcine-derived gelatin. Under the GR 42/2024 and the latest 2026 labeling circulars, is it mandatory to use a specific hexagonal warning frame or a particular font color for the 'Non-Halal' or 'Contains Porcine' statement? Furthermore, if the implant is too small for a physical label, can this warning be placed solely on the sterile barrier pouch or the secondary carton?
ElendiLabs
Yes, the "Non-Halal" statement must be clearly legible and typically displayed in a contrasting color (often red or high-contrast black) relative to the background. The text must deliver the message "Produk ini mengandung bahan bersumber babi" (This product contains porcine-derived materials).Small Device Exemption: For small implants where physical labeling is impossible, the MoH allows the warning to be placed on the primary packaging (like immediate sterile packaging )and the secondary packaging (like outer boxes). However, the IFU must contain a detailed description of the animal-derived component to ensure informed consent by the medical professional and the patient.
Anonymous
由于我们是全球化生产，很难在工厂流水线上为印尼单独定制印尼语包装。如果我们在 2026 年选择当地公司作为独立执照持有人 (ILH)，是否可以在货物抵达雅加达港口后，在保税仓库完成印尼语标签的张贴？在这种情况下，法律责任是由制造商承担还是由 ILH 承担？
ElendiLabs
贴标灵活性： 允许在进口后、分销前进行本地贴标。这在 2026 年依然是很多跨国公司的首选方案。责任划分： 在这种模式下，ILH 在法律上对标签的准确性负责。如果标签上的翻译误导了用户或遗漏了法定 NIE 编号，卫生部会首先向 ILH 追责。优势： 通过 ILH 进行本地贴标，您可以保持全球库存的通用性，仅在进入印尼市场时按需定制，极大地降低了库存呆滞风险。
tiffanylin
我们有一款 A 类（低风险）无菌敷料。根据 BPJPH CL 7/2025，2026 年 10 月 17 日后必须使用印尼国家清真标志。如果我们目前的包装上仍印有旧版的 MUI 标志，且库存预计在 2027 年才能耗尽，卫生部是否允许我们通过贴‘覆盖标签 (Over-labeling)’的方式进行过渡？还是必须重新印制整套包装？
ElendiLabs
标志切换： 2026 年 10 月 17 日是旧版 MUI 标志在 A 类器械上的“硬截止”日期。之后进入印尼市场的产品必须使用 BPJPH 国家清真标志。贴标许可： 印尼卫生部通常允许在保税区或进口商仓库通过贴标（Sticker/Over-labeling）进行修正，但贴纸必须具备抗撕裂、防潮且不可移除的特性。在 Regalkes 系统中申请 NIE（营销许可）变更时，您必须上传这种贴标方式的照片样张并获得批准。建议： 考虑到 2026 年的严格审查，建议在 2026 年第二季度起就切换生产模具，避免因贴标不牢固导致的市场抽检风险。
Approximately 5 minutes
Medical device registration in Indonesia, overseen by the MoH, requires a **local, licensed Sole Importer** to hold the non-transferable product license (NIE). The process utilizes the **ASEAN CSDT** and classifies devices into four risk classes (A-D), with review times ranging from 15 to 45 days, and mandates **ISO 13485** certification and **Reference Country** approval.
Approximately 5 minutes
IVD device registration in Indonesia is managed by the Ministry of Health (MoH) and requires a **local, licensed distributor** to hold the non-transferable product license. The process follows **GHTF/AMDD** guidelines for risk-based classification (Class A-D) and mandates both **Reference Country approval** and specific testing for high-risk devices like HIV reagents, with review timelines ranging from 30 to 90 days.
Approximately 5 minutes
Maintaining a medical device license (NIE) in Indonesia requires amendments for minor changes, renewal every five years, and adherence to evolving **Halal certification** requirements. Minor changes, such as labeling or packaging size, require an amendment application (IDR 1,000,000) that is typically approved within **3 months**, whereas all other significant changes necessitate a **new registration submission**.
Approximately 5 minutes
Post-Market Surveillance (PMS) is mandatory for medical devices in Indonesia, aligning with **ASEAN Post Market Vigilance guidelines**. The local **medical device dealer** is responsible for mandatory reporting of **Adverse Events (AEs)** and submitting **distribution records** through the MoH's online **E-Report and E-Watch Systems**, with severe events requiring reporting within **48 hours**.
Approximately 5 minutes
The Indonesian Ministry of Health (MoH) is the central regulatory body for medical devices, responsible for **pre- and post-market evaluation, standardization, and GMP certification**. The MoH utilizes the **Government e-Catalogue** for public procurement transparency and enforces **Good Method of Distribution of Medical Devices (CDAKB)**, while aligning its risk classification system (Classes A-D) with the **ASEAN Medical Devices Directive (AMDD)**.
amywu
为了响应环保要求，我们计划为 2026 年在印尼上市的 Class B 诊断设备全面推行 QR 码电子说明书。在 Permenkes 11/2025 下，如果我们在外包装上提供了指向官方印尼语说明书的 QR 码，是否可以免除包装盒内厚重的纸质版手册？如果必须保留，哪些核心信息必须以纸质形式呈现？