BAPETEN Audience with the BSN Regarding the Draft of BAPETEN Regulation on the Conformity Assessment Scheme for Diagnostic and Interventional Radiology X-ray Machines
Kembali 03 Juli 2025 | Berita BAPETEN | 14 lihatThe Nuclear Energy Regulatory Agency (BAPETEN) held an audience with the National Standardization Agency (BSN) regarding the Draft of BAPETEN Regulation on the Conformity Assessment Scheme for Diagnostic and Interventional Radiology X-ray Machines on Thursday, July 3, 2025, at the BAPETEN Office, Jakarta.
This audience was held as a follow-up to the Plenary Meeting on the Harmonization of the Draft of BAPETEN Regulation on the Conformity Assessment Scheme for Diagnostic and Interventional Radiology X-ray Machines, held by the Ministry of Law on June 23, 2025.
The activity was attended by Wahyu Purbowasito, Deputy for Accreditation, BSN; Singgih Harjanto, Head of the Human Resources, Legal, and Public Relations Bureau; and his staff. They were warmly welcomed by BAPETEN participants, including Haendra Subekti, Deputy Chairman for Nuclear Safety Assessment; Mukhlisin, Director of Regulation of Radiation Facilities and Radioactive Materials (DP2FRZR); Dedik Eko Sumargo, Head of the Centre for Regulatory Assessment of Radiation Facilities and Radioactive Materials (P2STPFRZR); and representatives from the Bureau of Legal Affairs, Cooperation, and Public Communication (BHKK); the Director of Regulation of Nuclear Installations and Materials (DP2IBN); and other relevant staff.
The activity began with remarks from Haendra, who explained that the implementation of the Indonesian National Standard (SNI) aims to improve product quality; provide protection for consumers, businesses, workers, and the wider community, including safety, security, and health; realize healthy business competition in trade; and enhance the competitiveness of domestic products. Currently, more and more businesses are seeking to establish X-ray machine production facilities, necessitating the government's development of product quality assurance instruments by developing regulations related to X-ray machine conformity assessment. This regulation applies to diagnostic radiology and interventional X-ray machines.
The activity continued with remarks from Wahyu, who emphasized the need for regulatory development to align with related regulations, particularly Government Regulation No. 34 of 2018 on the National Standardization and Conformity Assessment System. The mandatory implementation of SNI takes into account safety, security, health, and environmental preservation; the competitiveness of national producers and healthy business competition; the capabilities and readiness of the national business community; the readiness of LPK infrastructure; and culture, customs, or traditions based on local wisdom. and/or other national interests in accordance with statutory provisions. Therefore, it is highly appropriate to apply this SNI to X-ray products, but the necessary infrastructure is still needed for its implementation.
The activity concluded with a discussion session on the application of SNI for general radiography X-ray products, CT scan X-ray machines, and fluoroscopy X-ray machines for both domestic and imported products. Follow-up on the harmonization of the draft regulations is expected to create harmonious norms among related laws and regulations, and upon enactment, the regulations are expected to be implemented effectively. [DP2FRZR/Intanung/BHKK/OR/Translator: GP]










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