Transfer License for Ionizing Radiation Device (KBLI 46643)
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What Is an Transfer License for Ionizing Radiation?
This permit is an official authorization issued by BAPETEN (Nuclear Energy Regulatory Agency) allowing the transfer of ownership and operational responsibility for radiation-emitting devices from the importer/distributor to the end user. Without this permit, the equipment cannot be legally transferred or used in Indonesia.
Who Needs This License?
- Medical device distributors handling radiation-emitting equipment
- Importers of electromedical equipment (X-Ray, CT Scan, etc.)
- Companies listed under KBLI 46643
Key Requirements
- Certified Radiation Protection Officer (PPR Level 1) & supporting certified personnel
- Radiation safety analysis & protection program
- Proof of device ownership (AKL/NIE, distributor letter, handover report)
- Acceptance test results & leakage test documentation
- Quality compliance & certification of the device (CE, ISO, CFS)
- Radiation shielding building technical plan
License Application Process
- Initial consultation and document readiness assessment
- Document preparation and submission to BAPETEN
- Evaluation and verification by BAPETEN officers
- Issuance of the official import license
Why Choose Us?
- Extensive experience in business licensing for various industries
- Full support from SOP preparation to technical personnel
- Fast, transparent process in full compliance with regulations
FAQ – Frequently Asked Questions
- Is a transfer permit required for every X-Ray device?
Yes. All electromedical devices that contain ionizing radiation—such as X-Ray, CT Scan, or fluoroscopy equipment—must obtain a transfer permit before being used in healthcare facilities. - Is my company required to have a certified PPR Level 1 officer?
Yes. Every permit application must include a designated PPR Level 1 officer with an active BAPETEN certification, along with the latest six-month dose monitoring report. - Must the warehouse address match the one listed on the NIB?
Yes. The utilization site (typically a warehouse) must match the location registered in the latest NIB and OSS RBA system. - If the device is shipped directly to the hospital, is the transfer permit still necessary?
Yes. The transfer permit must still be issued under the name of the licensed importing company, even if the equipment is sent directly to a third-party user such as a hospital. - What are the consequences of not obtaining a transfer permit?
Without a valid transfer permit, the device is not legally authorized for use, and both the importer and end user may be subject to administrative or criminal penalties in accordance with BAPETEN regulations.
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