The arrival of the audience participants from BAPETEN was welcomed by the ranks of the Directorate General of Pharmaceuticals and Medical Devices, Ministry of Health, namely Eka Purnamasari, as Director of Medical Device Supervision and team, and Dede Mulyadi, as Director of Production and Distribution of Medical Devices and team. The event began with Mukhlisin's presentation of the purpose of the audience, namely introducing several BAPETEN policies that are closely related to the Ministry of Health, discussing the supervision of the production and distribution of diagnostic and interventional radiology X-ray machines, and government efforts or support from BAPETEN, the Ministry of Health, and other ministries or agencies for the production of domestically made X-ray machines.

In his presentation on the supervision of production and transfer (distribution) of diagnostic and interventional radiology X-ray machines, Mukhlisin said that support for radiology products has become a priority activity in the Renstra of the Ministry of Health of the Republic of Indonesia, Ministry of Industry of the Republic of Indonesia, and BAPETEN, which has been aligned with the RPJMN and RPJMP and has been submitted to Bappenas, but it is still considered necessary to carry out synergy with the Ministry of Health and other ministries/agencies. The basis for this policy is because, according to statistical data, 99% of radiology equipment (X-ray machines) is imported, while 1% is domestically produced. Therefore, as the Ministry of Maritime Affairs and Investment emphasizes that government support is needed for domestic products, in this case the production of radiology equipment can be monitored jointly not only by BAPETEN and the Ministry of Health but also involving other Ministries/Institutions. The production of irradiation equipment, including the production of X-ray machines with KBLI 26601. The main supporter is BAPETEN, but there are supporting supporters (PB UMKU) that overlap a lot with the Ministry of Health, so it is necessary to monitor so that domestic products, especially radiology equipment, can grow by establishing a simplified regulatory scheme, government support through facilities and infrastructure, and increasing human resources so that it can improve the investment climate and TKDN and not depend on foreign imports.

Furthermore, Muhklisin also said that currently the production of domestic X-ray machines has 2 manufacturers that already have production permits and produce quite a lot, especially mobile X-ray machines, but only as an assembly. However, there are many who are interested in producing X-ray machines by applying for a production permit. Thus, BAPETEN cannot be alone and needs to learn and align regulations or policies with the Ministry of Health, including the mechanism for testing product prototypes to have high quality, the interrelated licensing chain between BAPETEN and the Ministry of Health, and so on. In addition, this meeting also discussed Good Medical Device Production Methods (CPAKB), Good Medical Device Distribution Methods (CDAKB), distribution permits, product certification, and KBLI 46643 transfer permits.

From the Ministry of Health, Eka Purnamasari explained the mechanism for monitoring medical devices, which includes pre-market monitoring and post-market monitoring. Pre-market to ensure the suitability of products for distribution in terms of quality, safety, and benefits. In addition to products, pre-market monitoring also targets production facilities that are required to have a CPAKB certificate, and distribution facilities are required to have a CDAKB certificate. For post-market monitoring, which ensures that production facilities and distribution facilities remain committed to implementing CPAKB and CDAKAB, while monitoring is carried out on products by sampling and testing. CPAKB certification and CDAKAB certification are in the Directorate of Medical Device Supervision, while the Medical Device Distributor Permit (IDAK) and product distribution permit are in the Directorate of Medical Device Production and Distribution.

In the discussion session, knowledge and understanding were obtained including regarding the classification of distribution permits based on the risk class of medical devices where radiology devices are in class C, which permits are obtained first or as a requirement to apply for the next permit, either a permit from BAPETEN or from the Ministry of Health, the mechanism for importing raw materials for products and the inclusion of HS Codes, the difference between distribution permits at the Ministry of Health and transfer permits at BAPETEN, an explanation of the requirements (PB UMKU) for production permits for medical devices by the Ministry of Health in KBLI 26601, certification of medical device products in collaboration with the Health Equipment and Facilities Safety Center in testing. (DP2FRZR/Daniel RM/BHKK/GP)