Regulatory Update: Indonesia

In a significant move towards ensuring the safety and quality of medical devices in circulation, the Ministry of Health (MoH) of Indonesia has recently issued Circular Letter HK.02.02/E/1289/2023 on July 21, 2023. This directive focuses on the implementation of Medical Devices Post Market Testing, marking a crucial step in safeguarding public health.

The key objective of this initiative is to guarantee that all medical device products available in the market meet rigorous safety, quality, and efficacy standards. This move comes as part of the government's commitment to enhancing healthcare outcomes and protecting the well-being of its citizens.

Under these new regulations, post-market testing will be conducted at regular intervals in accredited testing laboratories. Each medical device will undergo comprehensive testing at least once every two years. The results of these tests will be meticulously documented and subsequently submitted to the Ministry of Health for evaluation.

This proactive approach to post-market testing not only instills confidence in the safety of medical devices but also demonstrates the government's dedication to upholding the highest standards in the healthcare sector.

By prioritizing ongoing assessments and monitoring, Indonesia sets an exemplary model for countries striving to establish robust regulatory frameworks for medical devices. This move is a testament to the nation's commitment to public health and underscores its resolve to provide its citizens with access to safe and effective medical technologies.

For the full resource in Indonesian (no English available) click HERE.