Audience of PT Graha Teknomedika and PT Mindray Indonesia to BAPETEN
Kembali 05 September 2024 | Berita BAPETENPT Graha Teknomedika and PT Mindray Indonesia conducted an audience with the Directorate of Regulation of Radiation Facilities and Radioactive Materials (DP2FRZR) BAPETEN in the context of regulatory consultations related to production permits for ionizing radiation generators used in medical facilities. The audience was held on September 5, 2024.
The event was opened by the Director of DP2FRZR BAPETEN Mukhlisin, who, in his opening remarks, conveyed, "In line with the government's commitment to the production of domestic X-ray machines, regulations related to production need to be deregulated in order to encourage domestic production and investment growth."
"Government Regulation No. 5 of 2021 on the Implementation of Risk-Based Business Licensing, which is currently in the process of revision, is expected to be stipulated and enacted in September before the inauguration of the elected president. Relevant to domestic production, BAPETEN is preparing regulations, one of which is the draft of the BAPETEN regulation (Raperba) on the Conformity Assessment Scheme for National Standards for Diagnostic and Interventional Radiology X-Ray Medical Device Products, which currently covers X-ray machines for general radiography, mobile, and CT scan," he explained.
The speech was continued by the Marketing Director of PT Graha Teknomedika, Febie Yuriza Poetri, who, in her speech, said, "PT Graha Teknomedika has the same spirit, supporting the government to produce X-ray machines. In addition, conveying the purpose of the audience with BAPETEN, namely to obtain an explanation related to licensing, regulations, and studies related to the production of ionizing radiation generators."
The remarks by the Marketing Director of PT Graha Teknomedika were continued with a presentation related to ionizing radiation generator products produced by PT Graha Teknomedika (stationary X-ray), fulfillment of permit requirements, a summary of the application for a production permit for ionizing radiation generators, results of field evaluations, trainings (on site) that have been carried out, obstacles still faced in licensing, namely related to expert personnel and quality control, demo units in production permit applications, and standard test methods for stationary X-ray machines.
Meanwhile, Market Access and Government Affairs PT Mindray Edi Rahman, in his remarks, said, "PT Mindray is the first multinational company to produce domestic X-ray machines in collaboration with several local companies. The collaboration with PT Graha Teknomedika is in producing stationary X-ray machines. This is part of Mindray's commitment to support the government in increasing domestic production."
The event, attended by BAPETEN personnel from the DP2FRZR, Directorate of Licensing of Radiation Facilities and Radioactive Materials (DPFRZR), Directorate of Regulation of Nuclear Installation and Materials (DP2IBN), and PT Graha Teknomedika and PT Mindray Indonesia work units, continued with a discussion session with topics of discussion including product certification assessment schemes, production standards, test standards, fulfillment of requirements, personnel (experts and quality control), personnel training, test parameters, and test methods.
From this activity, it is expected that PT Graha Teknomedika can immediately meet all requirements and immediately obtain product certification, and BAPETEN can immediately prepare instruments/regulations for the preparation of the Draft Regulation on the "Conformity Assessment Scheme for National Standards for Diagnostic and Interventional Radiology X-Ray Medical Device Products," which can later be implemented properly to support government efforts in improving the domestic investment climate. [DP2FRZR/IntanungSyafitri/BHKK/SP/Translator: GP]
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