Indonesia has followed ASEAN harmonization in the field of medical devices and ASEAN Medical Device Directives (AMDD) regulations. Indonesia is also an active member of APEC, WHO-SEARN, and actively participates in the GHWP, so the requirements and standards of medical device regulation in Indonesia also adjust to global practice.

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, is also affected if there are changes in regulations in other regions, including in Europe.

In 2017, the European Union established the Medical Device Regulation (EU MDR) and In Vitro Diagnostics Regulation (IVDR) as a replacement for the Medical Device Directive (EU MDD) and In Vitro Diagnostics Directive (IVDD) which then began to be applied from 2020 to 2024. With several changes to key concepts, the change of MDD and IVDD to MDR and IVDR has a significant impact on the industry and regulators, both in Europe and Non-EU countries, including Indonesia.

Therefore, increasing understanding of changes in medical device regulations is one of the important points in ensuring the safety, quality and benefits of medical devices. The competence of medical device evaluators is highly demanded, in order to significantly accelerate the medical device evaluation process and ensure the availability of medical devices needed according to safety, quality and benefit standards.

The Directorate General of Pharmaceuticals and Medical Devices through the Directorate of Production and Distribution of Medical Devices held an activity to increase the technical capacity of Central Human Resources in the Implementation of the Asean Medical Device Directive (AMDD) on 11-13 August 2022 at Bigland Sentul Hotel and Convention.

In his report, Director of Medical Device Production and Distribution Sodikin Sadek said that this hybrid activity was held as a means of updating information and knowledge, especially regarding the harmonization of medical device regulations according to global practice.

This activity was attended by 102 participants consisting of central participants from the Directorate of Medical Device Production and Distribution, Directorate of Pharmaceutical and Medical Device Resilience, Directorate of Medical Device and PKRT Supervision; as well as involving cross-sector participants consisting of representatives from the Electronics and Informatics Research Organization, National Research and Innovation Agency, Health Research Organization, National Research and Innovation Agency, Jakarta Health Facility Safety Center, Indonesian Medical Education and Research Institue (IMERI) Faculty of Medicine, University of Indonesia, as well as domestic and foreign medical device industries.

Online speakers from The Asia Pacific Medical Technology Association (APACMed) delivered presentations and discussions related to the European Union Medical Devices Regulation / European Union In Vitro Diagnostics Regulation including differences with the European Union Medical Devices Directive / European Union In Vitro Diagnostics Directive and its application to products.

Director General of Pharmaceuticals and Medical Devices Lucia Rizka Andalucia had the opportunity to officially open this activity. In her remarks and direction, the Director General said that this training can also be forwarded 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.

"I hope this meeting can obtain useful results and can encourage the improvement of the competence of medical device evaluators and also business actors in the field of Medical Devices and IVD Medical Devices," said the Director General.