# Indonesia Medical Device Classification Last reviewed: October 15, 2026 Indonesia medical device classification is informed by ASEAN and GHTF frameworks. Regulatory Overview ## How are devices classified? Indonesia's medical device and IVD classification scheme is largely informed by the Global Harmonization Task Force (GHTF) and Association of Southeast Asian Nations (ASEAN) frameworks. The scheme combines concepts from both frameworks to classify devices and IVDs according to their risk level from low to high: Class A, Class B, Class C & Class D. If your device is higher risk and more complex, you can expect more documentation requirements to support the clinical data, testing, and validation requirements necessary to demonstrate your device’s safety and effectiveness. Labeling and IFU requirements also expand for higher risk devices. ## Indonesia medical device classification tiers Medical devices and IVDs are classified into four tiers: - Class A, low risk level to user, patient, or public (e.g., band-aids and examination gloves). - Class B, moderate risk level to user, patient, or public (e.g., blood pressure monitors and thermometers). - Class C, moderate-high risk level user, patient, or public (e.g., electrosurgical instruments and catheters); and - Class D, high risk level to user, patient, or public (e.g., implantable pacemakers; other implants require their specific rule). ## Medical device grouping in Indonesia Medical devices can be grouped in one application for registration. In general, grouping principles include: - Same intended use; - Used in combination to achieve intended use; or - Similarity in products to simplify distribution permits. There are several different grouping categories with specific grouping requirements. For instance, grouping requirements for a family of devices that are similar in their intended use are different than for a system of devices, which are intended to be used together. It’s important to consider different labeling and IFU requirements that apply to different grouping categories. ## Classification evidence and the registration handoff For the [Indonesian Ministry of Health](https://www.pureglobal.com/glossary/indonesia-moh), document the intended medical purpose, professional or lay user, patient population, body contact, invasiveness, duration and active function before selecting a class. General-device and IVD rules require separate analysis: the public-health consequence of an incorrect diagnostic result is relevant even when the test itself does not contact the patient. Keep a rationale naming the applicable rule and the model configurations covered. A US or EU class is supporting context rather than a substitute for Indonesian classification. For software and AI products, also review the current Ministry software guidance described in our [KMK 951 update](https://www.pureglobal.com/news/indonesia-kmk-951-2026-software-medical-device-guideline). Agree the grouping scope with the local holder, then reconcile device names, models and intended use across the CSDT and [labels](https://www.pureglobal.com/markets/indonesia/medical-device-labeling). Use the [registration portal](https://regalkes.kemkes.go.id/) for the current class-specific filing requirements and tariffs; historical USD conversions and quoted review days are not a current fee or launch commitment. How We Can Help ## Full Indonesia Support for a Simple Annual Fee Plan your device registration, local representation and ongoing compliance with Pure Global. [Contact us](https://www.pureglobal.com/contact)[Pricing](https://www.pureglobal.com/services/pricing?country=ID) ![Pure Global market entry support team](https://www.pureglobal.com/assets/owned/75037ea614--67ab304f89cb5422fdc63bc7__67ab304f89cb5422fdc63d5e_feature_5.webp) ## Frequently asked questions ### How does classification affect Indonesian registration fees? Class and application type affect the current Ministry tariff and evidence requirements. Check the amount in the registration system and distinguish government fees from local representation, translation, testing and dossier preparation costs. ### Does Indonesia accept a foreign risk classification automatically? No. Apply the Indonesian rules to the device’s intended purpose and risk characteristics. Keep a written rationale and reconcile any difference from the foreign class before selecting the dossier scope or grouping. ### Can IVDs share a single Indonesian application? Potentially, where the current IVD grouping criteria are satisfied. Identify the permitted category, common intended purpose and covered configurations, and retain evidence supporting the group rather than relying only on a shared brand name. ## Single Process, Multiple Markets When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible. 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