For Class A medical device registration with Indonesia's Ministry of Health (MOH), compliance with both international and Indonesian national standards is required. These standards ensure that the medical device is safe, effective, and of high quality.

For Class A medical device registration with Indonesia’s Ministry of Health (MOH), you need to submit comprehensive technical documentation to demonstrate the safety, performance, and quality of the device. Although Class A devices are considered low-risk, the MOH still requires essential technical documents to ensure that the device complies with regulatory standards.

The processing time for Class A medical device registration with Indonesia’s Ministry of Health (MOH) can vary depending on several factors, including the completeness of the application and the volume of applications being processed. However, for Class A devices (low-risk devices), the process is generally quicker compared to higher-risk classifications (B, C, D).

To apply for Class A medical device registration with Indonesia’s Ministry of Health (MOH), several regulatory conditions and requirements must be met. These conditions ensure that the device complies with Indonesian health, safety, and quality standards.

To apply for Class A (low-risk) medical device registration with Indonesia’s Ministry of Health (MOH), follow the steps below. The application must be submitted through the official MOH registration system.

Business license (SIUP) or equivalent document of the local representative.

Ensure the product qualifies as a Class A medical device (low risk) under Indonesia’s classification system.

To apply for Class A medical device registration with Indonesia’s Ministry of Health (MOH), you must submit the application through the ASPAK (Sistem Perizinan Alat Kesehatan) system, which is the official online portal for medical device registration in Indonesia.