The Ministry of Health continues to encourage increased production and use of domestic medical devices from the research and development stage to the sales stage.

Currently, the development of medical devices is very rapid, so medical device regulations and policies must always be updated following the development of global regulations. For this reason, harmonization of medical device regulations is needed in order to minimize regulatory barriers and facilitate trade access between countries. 

In supporting the harmonization of medical device regulations that are beneficial for the advancement of the medical device industry in Indonesia, the Ministry of Health through the Directorate General of Pharmaceuticals and Medical Devices collaborates through information exchange and best practices in implementing medical device regulations with the China National Medical Product Administration (NMPA). June 23, 2024, Director of Medical Device Supervision Eka Purnamasari together with a team from the Directorate of Medical Device Production and Distribution, a team from the Directorate of Pharmaceutical and Medical Device Resilience and the leaders of the Technical Implementation Unit for the Safety of Medical Devices and Health Facilities (PAFK) visited the Center for Medical Device Testing and Inspection (CMTC): Shanghai Institute of Medical Device, which is a medical device testing institution for the needs of pre-market testing (distribution permit registration) and post-market (testing / calibration in health facilities) in China.

The visit was then followed by a 3-day training (June 24-26, 2024) at Shanghai United Imaging Healthcare (UIH) on quality management systems, clinical evaluation/testing, high-tech medical devices (Software as Medical Device, Artificial Intelligent) and post market surveillance. After several series of agendas, on June 27, 2024, the Director General of Pharmaceuticals and Medical Devices, L. Rizka Andalucia, accompanied by a team from the Directorate General of Pharmaceuticals and Medical Devices, conducted benchmarking of medical device regulations to the NMPA located in Beijing-China.

Through this benchmarking, it is expected that medical device regulations and policies in Indonesia can be aligned with global regulations, especially those related to pre-market evaluation, post-market control and medical device standards. In addition, it can strengthen cooperation and communication between the Ministry of Health and NMPA-China to ensure the safety and quality of medical devices globally.

This series of activities is expected to increase knowledge about the regulation and testing of medical devices so as to increase the contribution to efforts to guarantee the safety, quality and benefits of medical devices in Indonesia, especially domestic products.