Registration of Radiation-Based Medical Devices in Indonesia: The Dual Regulatory Pathway of BAPETEN and MOH Cannot Be Ignored! - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

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Registration of Radiation-Based Medical Devices in Indonesia: The Dual Regulatory Pathway of BAPETEN and MOH Cannot Be Ignored!

Time：2026-09-17 11:40:18

Want to export X-ray machines, CT, CBCT, mammography and other ionizing radiation medical devices to the Indonesian market? Registering only with the Ministry of Health (MOH) of Indonesia is far from sufficient. Indonesia implements dual regulation by the Ministry of Health (MOH) and the Nuclear Energy Regulatory Agency (BAPETEN) for radiation-based medical devices. BAPETEN permits even serve as a prerequisite to initiate MOH registration, and many enterprises hit roadblocks at this stage.

一、Core Regulatory Logic

In Indonesia, the registration process for all ionizing radiation medical devices follows a clear sequence: Step 1: Obtain relevant permits from BAPETEN (Nuclear Energy Regulatory Agency) Step 2: Submit the medical device registration certificate (NIE/AKL) application to Indonesia’s Ministry of Health (MOH)

Key point: For medical devices involving ionizing radiation, relevant BAPETEN permit documents are one of the supporting documents required for the medical device registration application. The specific permit types and submission timing shall be confirmed according to the product and applicant entity.

二、Local Certificate-Holding Agent

Radiation-related products impose far higher qualification requirements on Indonesian local agents than ordinary medical devices. Agents need to prepare qualifications, personnel and warehouse conditions in advance, and accept on-site audits. Local certificate-holding agents must meet five mandatory requirements:

Qualification Add-ons：Confirm NIB/KBLI, medical device distribution qualifications and relevant BAPETEN permits required for local import/distribution entities according to the actual business model.

Personnel Allocation：Facilities that physically use ionizing radiation must deploy radiation protection personnel (PPR) and other relevant staff with corresponding qualifications and authority as required.

Warehouse Facility Renovation：If the project involves the physical installation and use of equipment, the facilities of relevant hospitals/clinics shall meet site, radiation shielding and safety requirements per BAPETEN rules.

On-site Audit：Local distributors must accept on-site inspection by BAPETEN. Non-compliant warehouse radiation facilities will directly interrupt the whole registration process.

Local Testing Risk Reminder：Although the probability is low, Indonesia’s Ministry of Health (MOH) reserves the right to require local laboratory testing. Sampling, inspection or other conformity requirements may be involved depending on specific regulatory arrangements, subject to the actual requirements of competent authorities.
三、Three Essential Nodes for Radiation Product Registration

（一）BAPETEN Product Notification
Before or during the MOH medical device registration application, you need to establish a product profile in the BAPETEN BALIS system, and file the radiation parameters, ray source and other data of this model of equipment.

（二）BAPETEN Import Permit for Medical Device Safety
Radiation equipment carries potential safety risks. MOH registration certificate alone cannot clear customs in Indonesia. For each shipment of goods, you must hold an import permit or clearance letter (Permit for Import/Shipment) issued by BAPETEN, which is a mandatory customs clearance document for Indonesian customs release.

（三）BAPETEN Utilization License
For end-use scenarios such as hospitals, clinics and physical examination centers, before the equipment is officially powered on and put into use, the user entity (or the agent responsible for installation, operation and maintenance) must apply for this utilization license. The application generally requires a person in charge holding a valid PPR protection certificate.
四、Practical Recommendations for Export Enterprises

Radiation-based medical devices are not ordinary medical devices. BAPETEN acts as a pre-gatekeeper. Do not start preparing radiation-related qualifications only at the MOH registration stage.
Local agents cannot be selected arbitrarily. Personnel recruitment, radiation chamber renovation for warehouses and on-site audits all need advance planning; otherwise, the project is highly likely to be suspended.
BAPETEN import permits are applied for by shipment, not a one-time registration for permanent customs clearance. For end-user installation and operation, a separate utilization safety license is still required.
Reserve risk buffer period: Take into account potential time and cost increments if MOH initiates local laboratory testing.

五、Conclusion

Indonesia’s dual regulatory system for ionizing radiation medical devices has high thresholds and a long workflow. Many overseas manufacturers mistakenly believe that holding MOH registration is sufficient, ignoring BAPETEN pre-permits and local agent requirements for personnel and warehouse audits. This eventually leads to suspended registration and goods stuck at customs.If you need further information, feel free to consult Wiselink!

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