The event began with a report from Soegeng Rahadhy, the Activity Coordinator for the Health, Industry, and Research Regulation Group DP2FRZR, who stated, "This guidance activity regarding regulations for radiation facilities and radioactive materials is organized as part of efforts to improve regulatory effectiveness and strengthen stakeholder understanding of safety and security aspects in the utilization of radiation sources. The activity is designed to provide updates, harmonize regulations, and build a shared understanding among BAPETEN, industry players, healthcare facilities, and other relevant institutions."

"Through the series of presentations and discussions prepared, we hope this forum serves as a platform for sharing technical information, aligning with the latest policies, and strengthening the safety culture across all sectors utilizing radiation facilities and radioactive materials," he added.

The event was opened by BAPETEN’s Deputy Chairman for Nuclear Safety Assessment, Haendra Subekti. In his remarks, he noted, "BAPETEN Regulation Number 1 of 2025 does not include a transition period and will come into effect immediately upon promulgation; therefore, this guidance session is crucial for aligning understanding regarding regulatory changes, particularly concerning conformity assessment and product certification schemes." “This regulatory change serves as a crucial foundation for ensuring that X-ray equipment circulating in Indonesia complies with the Indonesian National Standard (SNI). Through synergy with BSN, BPFK, and other testing and certification bodies, it is expected that all manufacturers, both domestic and importers, will align with the certification scheme so that marketed products bear the SNI label. SNI-certified products will demonstrate conformity with international standards adopted into national regulations, providing quality assurance while enhancing safety during their use,” he emphasized.

“This forum is intended to serve as an effective platform for technical communication, ensuring that all parties understand the certification process, the recognition of foreign-made equipment, conformity assessment procedures, and coordination mechanisms with the regulatory directorate. I hope all participants engage in active discussion, offer critical input, and maintain ongoing communication to ensure the successful implementation of the regulation and the strengthening of the safety culture in Indonesia,” he added.

The event, attended by 120 participants, featured a series of presentations, namely:

1. BAPETEN Regulation Number 1 of 2025 on Conformity Assessment of X-ray Equipment in Diagnostic and Interventional Radiology, presented by Anet Hayani, radiation supervisor at BAPETEN.

2. BSN Regulation Number 6 of 2025 on Conformity Assessment Schemes for Indonesian National Standards in the Medical Equipment Product Sector, presented by Syaiful, Standardization Analyst at the National Standardization Agency (BSN).

3. Procedures for Requesting Recognition of Imported Diagnostic and Interventional Radiology X-ray Equipment and the Certification Process for Domestically Produced Diagnostic and Interventional Radiology X-ray Equipment, presented by M. Subchansyah, Head of the Medical Equipment Certification Installation at the Jakarta Center for Health Equipment and Facility Safety (BPFK), Ministry of Health.

During the discussion and Q&A session moderated by Mukhlisin, Director of DP2FRZR, participants extensively discussed the implementation of new regulations, the readiness of manufacturers and importers, equipment recognition mechanisms, certification requirements, and coordination among testing bodies, regulators, and business operators.

The event concluded with remarks from Mukhlisin, who expressed "appreciation to all speakers, manufacturers, importers, users, professional associations, government stakeholders, and relevant organizations for their active participation in this guidance session. Implementing conformity assessment regulations, including BAPETEN Regulation Number 1 of 2025 and BSN regulations, requires a shared commitment to ensure that X-ray equipment in circulation, whether domestically produced or imported, meets safety and quality standards in accordance with SNI. Today’s discussion, which covered topics ranging from conformity assessment, certification schemes, and country-of-origin recognition procedures to the readiness of testing and certification bodies, is expected to strengthen the understanding and preparedness of all parties in consistently implementing these regulations."

“The government, through BAPETEN, BSN, the Ministry of Health, and conformity assessment bodies, will continue to enhance infrastructure readiness, including by encouraging more Product Certification Bodies (LSPro) and testing laboratories to participate in the certification process so that reliance is not placed on a single institution. He highlighted the importance of simplifying procedures, ensuring inter-agency consistency, maintaining cost affordability, and fostering effective communication, including the potential establishment of a coordination group to ensure that business operators and brand owners do not face obstacles during certification or recognition processes. It is expected that the outcomes of today’s discussion can be promptly acted upon and serve as a shared foundation for improving radiation safety, product quality, and patient protection across all healthcare facilities,” he concluded. [BHKK/HafidReyhanUlyFuad/SP/Translator: GP]