Indonesia is one of the ASEAN member countries committed to improving the safety and quality standards of medical devices, which are harmonized through the ASEAN Medical Device Directives (AMDD). As part of this commitment, Indonesia along with other ASEAN countries have ratified the AMDD and officially adopted it into national regulations in 2018.

In facing global health challenges and encouraging innovation and technological advances in the medical device sector, the Ministry of Health through the Directorate of Medical Device Production and Distribution organized the 13th ASEAN Medical Device Committee (AMDC) in Yogyakarta from 10 to 13 September 2024.

The meeting was attended by representatives of eight ASEAN countries, namely Laos, Malaysia, Myanmar, Singapore, Thailand, Vietnam, Cambodia, and Brunei Darussalam. In addition, the 13th AMDC also collaborated with two Asia Pacific-level associations, namely the Asia Pacific Technology Association (APACMed) and the Pharmaceuticals and Medical Devices Agency (PMDA), which contributed to sharing knowledge and deepening insights into regulation and innovation in the medical device sector.

Director General of Pharmaceuticals and Medical Devices, L. Rizka Andalucia, in her speech emphasized the importance of this activity to oversee and ensure the implementation of AMDD in all ASEAN countries. “The purpose of this activity is to strengthen the harmonization of medical device regulations in accordance with AMDD, so that ASEAN countries can jointly face global challenges, while encouraging innovation and technological advances in the medical device sector,” Rizka said.

Rizka expressed her hope that this series of meetings will make a major contribution in improving the health status and welfare of the community, not only in ASEAN but also at the global level. “I really hope this meeting will give birth to new ideas to strengthen regulations, innovation, and medical device technology, so that it can improve the health status of people around the world,” said Rizka.

In addition, the 13th AMDC is a strategic forum for regulators, industry, and stakeholders to exchange information, expand networks, and solve medical device regulatory challenges. With close collaboration among stakeholders, regulators and industry, it is hoped that innovation and improvement of medical device safety and quality standards that meet global needs will be achieved.

“I believe that through regulatory harmonization and effective collaboration, we can achieve our common goal of improving public access to safe, high-quality, and innovative medical devices. Let us continue to work together and commit to achieving this vision” concluded Rizka.