The development of harmonization of medical device regulations both at the ASEAN and global levels is one of the important components in ensuring the safety, quality and benefits/performance of medical devices. Indonesia as one of the countries with comprehensive medical device regulations, must continue to update regulations that follow technological developments.

The medical sector is very close to the use of technology that is always developing rapidly. This character requires regulators in the health sector to always adapt to new technologies. Increased understanding of the development of medical device technology is one of the important points in ensuring the safety, quality and benefits of medical devices.

In line with this, on 8 - 10 September 2022 the Directorate General of Pharmaceuticals and Medical Devices through the Directorate of Medical Device Production and Distribution again held a Meeting to Improve the Technical Capability of Human Resources in Implementing the Asean Medical Device Directive (AMDD) at the Royal Padjadjaran Hotel, Bogor.

In this training, topics were discussed in accordance with technological developments, ranging from the Innovation Landscape of the Medical Device Industry, Quality Management System, Artificial Intelligence and Software as a Medical Device, Electrical Safety, Pre-clinical and Clinical tests/Evaluation to those related to Post Market medical device testing.

This meeting was held in collaboration between the Directorate General of Pharmaceuticals and Medical Devices and the USAID - Medical Device Regulatory Convergence Project (MDRC) team.

Director of Production and Distribution of Medical Devices Sodikin Sadek in his report said that the meeting which was held online and offline was attended by around 102 participants including central participants from the Directorate General of Pharmaceuticals and Medical Devices and also involved cross-sector participants consisting of representatives of the Electronics and Information Technology Research Organization, the National Research and Innovation Agency, the Health Research Organization, the National Research and Innovation Agency, the Health Facility Safety Center throughout Indonesia, the Indonesian Medical Education and Research Institue (IMERI) Faculty of Medicine, University of Indonesia, the domestic medical device industry and medical device distributors.

"This activity is carried out as a means of updating information and knowledge, especially regarding the harmonization of medical device regulations according to global practice, this is to ensure that medical devices circulating in Indonesia have met safety, quality and benefit standards, and can be accepted at home and abroad," said Sodikin.

Director General of Pharmaceuticals and Medical Devices L. Rizka Andalucia in her speech when opening the meeting officially said that this competency improvement is in line with the Ministry of Health's priority program within the framework of the Digital Transformation of the Health Security System.

"I hope that this activity can be utilized as well as possible, especially for evaluators to improve their competence, and for the Directorate in an effort to harmonize regulations and achieve indicators," said the Director General.

Furthermore, the Director General said that technological developments have an impact on the industry as business actors in registering their products to obtain distribution permits. In its active role in meeting the requirements for safety, quality and benefits in exporting and importing medical devices, the industry needs to keep abreast of regulatory developments in other countries and regions.

"For this reason, collaboration is the main key to accelerate communication in implementing regulatory changes. I hope this training can also be passed on to other medical device industry colleagues, both to increase competence in Good Submission Practice, as well as for industries that will enter the European market," said the Director General.

Special Staff of the Indonesian Minister of Health for the Resiliency of the Pharmaceutical and Medical Device Industry, Prof. dr. Laksono Trisnantoro in closing the activity said that in the future it is necessary to develop the capacity of various strategic issues in the medical device industry with meetings, training and benchmarking with neighboring countries.