Coordination Meeting for Technical Consultation Request for Building and Production Permit Facilities, and Product Certification of Ionizing Radiation Generator Manufacturer PT Siemens Healthineers Indonesia
Kembali 14 November 2024 | Berita BAPETENThe Directorate of Regulation of Radiation Facilities and Radioactive Materials (DP2FRZR) of the Nuclear Energy Regulatory Agency (BAPETEN) held a Coordination Meeting for Technical Consultation Request for Building and Production Permit Facilities and Product Certification of Ionizing Radiation Generator Manufacturer PT Siemens Healthineers Indonesia at the BAPETEN Office on Thursday, November 14, 2024. This meeting was attended by PT Siemens Healthineers Indonesia and related work units in BAPETEN, namely the Directorate of Licensing of Radiation Facilities and Radioactive Materials (DPFRZR), the Centre for Regulatory Assessment of Radiation Facilities and Radioactive Materials (P2STPFRZR), and the Directorate of Technical Support and Nuclear Emergency Preparedness (DKKN).
The meeting was opened by the Director of DP2FRZR, Mukhlisin, who said that the use of nuclear technology is increasingly developing, including in industry, medicine, and research. He also said that the Indonesian government is currently supporting the development of domestic medical device production, including general radiography X-ray machines, CT scans, and fluoroscopy, with the aim of reducing imports of medical devices.
"Support from the government is in the form of regulations for the production of medical devices and encouraging Domestic Component Level (TKDN) for local medical devices. In this case, BAPETEN has the main task, one of which is to ensure that the X-ray machines produced are in accordance with radiation safety standards," he said.
Furthermore, Head of Government Affairs & Quality Wulaning Putri Sunuwati and SCM AT Global & Project Manager for Cathlab Localization of PT Siemens Healthineers Kai Froelich said that they are currently preparing to build a medical device company to make local products, especially angiography X-ray machines, in Indonesia. In the construction process, confirmation will be made to BAPETEN as to whether the preparations that have been made are in accordance with applicable regulations.
PT Siemens Healthineers Indonesia expected that through this meeting it could fulfill all regulations in Indonesia to produce domestic medical devices and get direction from BAPETEN in terms of production facilities so that it could produce good product quality.
The technical consultation coordination meeting activity went smoothly, and concluded that PT Siemens Healthineers Indonesia has understood all existing regulations, so that there are no problems in submitting permits in Indonesia. With the holding of this meeting, it is expected to strengthen collaboration and cooperation so that what has been planned by PT Siemens Healthineers Indonesia in producing domestic X-ray angiography machines can be realized soon. [Tiwi Ulvia Agista/DP2FRZR/BHKK/Da/Translator: GP]
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