The implementation of health care is influenced by three main components, namely drugs, medical devices and health workers. These three components must be available in affordable, quality and quality conditions.

By optimizing the quality and use of domestically produced medical devices, the Ministry of Health is committed to improving the resilience of medical devices through Health Transformation.

Director of Medical Devices Production and Distribution, Dede Mulyadi, stated that in realizing the implementation of health care that are effective and appropriate, especially the components of drugs and medical devices, coordination is needed in all supporting sectors.

For this reason, on November 28 to 29, 2024, the Directorate General of Pharmaceuticals and Medical Devices through the Directorate of Production and Distribution of Medical Devices carried out Cross-Sector Coordination and Inspection Evaluation Analysis in the Context of Strengthening the Quality of Medical Devices as an effort to increase collaboration between stakeholders who play a role in ensuring quality medical devices.

The activity, which was held at the Alana Solo Hotel, Karanganyar Regency, included seminars and discussions from several resource persons, an exhibition of domestic medical devices, and business matching involving relevant stakeholders, namely Hospitals, and Domestic Medical Device Manufacturers.

The series of discussions in the activity included the implementation of the National Formulary, SAS Drug and SAS Medical Device regulations, as well as Clinical Trials of Medical Devices and Strengthening the Safety, Quality and Benefits of Medical Devices in Hospitals. This is expected to be a reference that can be implemented properly in each work unit, so that various obstacles faced in this regard can be minimized in the future.

In addition, there were also presentations from medical device associations related to the role of medical device quality assurance at the Pre-Market and Post-Market stages, delivered by representatives of ASPAKI, GAKESLAB, and HIPELKI. Hopefully, representatives from hospitals can understand the role of associations in supporting the development of better domestic medical devices.

Acting Director General of Pharmaceuticals and Medical Devices, Heri Radison, in his direction focused on discussing the development of the quality of medical devices that have been carried out in various pre-market and post-market stages, which include product development, planning, procurement, use, reporting, and maintenance of medical devices.

Furthermore, Heri said that in the early stages of medical device product development, hospitals have an important role in strengthening the implementation of clinical trials of medical devices, which is one of the quality assurance of medical devices.

In addition, in increasing and producing the use of domestic medical devices, it is necessary to pay close attention to the evaluation of the use of domestic medical devices at the post-market stage. This is necessary to improve the quality of domestic medical devices through improvements that must be made by manufacturers from the evaluation results.

“Efforts to improve the quality of domestic medical devices are important things that we must realize together, so that products can be increasingly accepted by users. In this case, the role of the test laboratory is also needed in supporting the guarantee of safety, quality and benefits of medical devices through medical device testing,” said Heri.

This effort must be carried out jointly and continuously. Heri hopes that through this activity cross-sector coordination can be carried out so that a harmonious relationship between providers and users can be established, so that domestic medical devices can be maximally used and produced according to the needs of health services in Indonesia.