1. The BAPETEN Transfer License is a mandatory permit that distributors must obtain before distributing radiation medical devices. This license ensures that the radiation medical devices comply with BAPETEN’s safety standards and guarantees that the products can be safely sold. Radiation medical devices refer to equipment that emits radiation during use, such as X-rays, CT scans, etc. 2. Benefits of obtaining the BAPETEN Transfer License: a. Allows the distribution of radiation medical devices; b. Ensures safety and effectiveness in the use of radiation medical devices. 3. According to BAPETEN Regulation No. 3 of 2021, companies applying for the BAPETEN Transfer License can be 100% foreign-owned. Indonesia implements an exclusive agency system, with business scope including 46643. 4. Technical requirements for applying for the BAPETEN Transfer License under BAPETEN Regulation No. 3 of 2021: a. Must have a Radiation Safety Officer (PPR); b. Must have a technician; c. Must possess documents and information related to radiation products. 5. Requirements for Radiation Safety Officer (PPR) and Technician:
6. Warehouse regulations for the BAPETEN Transfer License apply to warehouse zones and shop houses (Ruko), with the following conditions: a. The warehouse address must be stated in the NIB and must match the actual location, which must be within an Industrial Estate (KI or KPI); b. The office and warehouse can share the same address; c. If the office and warehouse are at different addresses, both must be listed in the NIB. 7. Equipment required when applying for the BAPETEN Transfer License: a. Surveymeter b. Medical protective clothing (if applicable) c. TLD d. Radiation warning symbol e. Information board (if applicable) 8. Currently, the BAPETEN Transfer License is valid for 5 years. |
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Processing Time : 2 Months 1. Primary-level SIB (Work Practice License) for the PPR 2. STR (Technician Registration Certificate) for equipment installation technicians/radiation personnel 3. Residence statement for PPR and technician 4. Scanned copies of PPR and technician’s graduation certificates 5. Scanned copies of PPR and technician’s ID cards 6. PPR declaration letter confirming employment at the relevant company 7. Company appointment letter for PPR and technician as radiation workers 8. BPFK/BRIN proof of TLD badge service (zero-check) for PPR and technician 9. Dose card for the TLD badge 10. Medical examination results of PPR and technician 11. Calibration certificate for the survey meter/radiation measuring device 12. Cooperation letter with BPFK as the LUK (Qualified Testing Agency) testing team 13. Notarized factory power of attorney and statement from the Indonesian Trade Attaché/Apostille (included in the power of attorney attachments) 14. Factory declaration letter (ensuring supply of goods during the BAPETEN license validity period) 15. Declaration letter regarding foreign users 16. Training certificates for PPR and technician issued by the factory 17. ISO quality certificate 18. EC quality certificate 19. EC Declaration of Conformity certificate 20. Certificate of Free Sales (CFS) 21. Manufacturer’s declaration letter regarding X-ray tubes 22. Tube specifications 23. X-ray equipment catalog 24. X-ray equipment specifications 25. Product manual for X-ray type 26. Standard Operating Procedure (SOP) for management regulations 27. AKL Certificate |