For Class I medical device registration with the Indonesia Ministry of Health (MOH), through the BPOM (National Agency of Drug and Food Control), the device must meet a variety of regulatory standards to ensure that it is safe, effective, and compliant with Indonesian health and safety requirements. These standards are in line with both national regulations and international standards, providing a framework for the safety and performance of medical devices in Indonesia.

For Class I medical device registration with the Indonesia Ministry of Health (MOH) through BPOM, the technical document requirements are generally less stringent compared to higher-risk medical devices (Class II and III), but they still need to comply with specific regulatory standards. The required technical documents ensure that the device is safe, effective, and compliant with Indonesian laws.

The processing time for Class I medical device registration with the Indonesia Ministry of Health (MOH), through the BPOM (National Agency of Drug and Food Control), is generally faster compared to higher-risk classes (Class II and III). However, the exact duration can vary depending on several factors such as the completeness of the application, BPOM’s workload, and any additional requirements or clarifications needed.

To apply for Class I medical device registration with the Indonesia Ministry of Health (MOH) through the BPOM (National Agency of Drug and Food Control), certain conditions must be met. These conditions ensure that the device complies with Indonesian regulations and is deemed safe and effective for use in the country. Below are the main conditions that must be met for Class I medical device registration in Indonesia.

To apply for Class I medical device registration with the Indonesia Ministry of Health (MOH), the process is done through the e-RD (electronic Registration) system, which is managed by the Indonesian National Agency of Drug and Food Control (BPOM). The local authorized representative (AR) is required to handle the submission process, as foreign manufacturers cannot submit directly. Below is a detailed guide on how to apply for Class I medical device registration and where to submit the application.

For Class I medical device registration with the Indonesia Ministry of Health (MOH), there are specific materials and documents that must be prepared and submitted through the e-RD system (electronic Registration system) managed by the Indonesian National Agency of Drug and Food Control (BPOM). Below is a detailed list of the required materials, along with guidance on how to prepare the application documents.

The process of registering a Class I medical device with the Indonesia Ministry of Health (MOH) involves several key steps, along with specific documentation requirements and important considerations. Below is a detailed breakdown of the process, documents, and considerations to ensure successful registration.

You can apply for Class I medical device registration with the Indonesia Ministry of Health (MOH) through the e-RD (electronic Registration) system, which is the official online platform for medical device registration in Indonesia.