The device must be classified as a B-class medical device according to BPOM's risk classification system. B-class devices are those that present moderate risks to health and typically require standard documentation and compliance with safety and performance requirements.

To apply for B-class medical device registration in Indonesia, you must go through the Indonesian Food and Drug Authority (BPOM) under the Ministry of Health (MOH). The application process is primarily handled through BPOM's e-Registration portal.

For registering a B-class medical device in Indonesia with the Ministry of Health (MOH) and BPOM, you will need to prepare a range of specific materials. These materials are essential for demonstrating the safety, efficacy, and compliance of your device with Indonesian regulatory standards.

Registering a B-class medical device in Indonesia involves a multi-step process through the Ministry of Health (MOH) and the Indonesian Food and Drug Authority (BPOM). The following outlines the process, the materials you need to prepare, and important precautions to ensure a smooth registration.

In Indonesia, the application for B-class medical device registration is handled by the Indonesian Food and Drug Authority (BPOM), which operates the regulatory framework for medical devices under the Ministry of Health (MOH).

The cost and timeline for registering a B-class medical device in Indonesia with the Ministry of Health (MOH) and BPOM can vary depending on several factors, such as the type of device, the complexity of the registration process, and the need for additional testing or inspections.

To apply for B-class medical device registration in Indonesia with the Ministry of Health (MOH) and BPOM (Badan Pengawas Obat dan Makanan), you need to meet certain requirements and submit specific documentation as part of the application process. B-class devices are considered to have moderate risk and require a detailed review to ensure compliance with safety and performance standards.

Registering a B-class medical device in Indonesia through the Ministry of Health (MOH) and the Indonesian Food and Drug Authority (BPOM) involves several key steps. B-class devices are considered to have moderate risk to patient health and require a more detailed registration process than lower-risk A-class devices but are less rigorous than higher-risk C- and D-class devices.