The cost and timeline for registering a D-class medical device in Indonesia with the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM) can vary depending on several factors, including the specific device, the completeness of the application, and BPOM's current workload. However, there are general guidelines you can expect in terms of both cost and time.

In Indonesia, the registration of medical devices is regulated by the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM). Medical devices are classified into four classes (A, B, C, and D) based on their risk level. D-class devices are considered low-risk devices and are subject to less stringent regulatory requirements compared to higher-risk devices. However, the registration process still requires the submission of various documents and compliance with Indonesian standards.

The registration of a D-class medical device (low-risk medical device) in Indonesia is regulated by the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM). The process is relatively straightforward compared to higher-risk classes, but it still requires careful attention to compliance with Indonesian regulatory standards.

In Indonesia, medical devices are classified into four classes (A, B, C, and D) based on the level of risk associated with the device. D-class medical devices are considered low-risk devices. These are typically devices that pose minimal risk to patient safety and health, and their use does not involve invasive procedures.

To apply for D-class medical device registration in Indonesia with the Ministry of Health (MOH), the process typically involves several key steps.

The processing time to obtain Class C medical device registration in Indonesia under the Ministry of Health (MOH) and BPOM can vary depending on several factors, such as the complexity of the device, the completeness of the application, and whether additional documentation or inspections are required.

Yes, annual renewal is required for the Class C medical device registration in Indonesia under the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control).

The purpose of applying for Class C medical device registration in Indonesia under the Ministry of Health (MOH) is primarily to ensure that medical devices meet the necessary regulatory standards for safety, efficacy, and quality before they are allowed to be marketed, distributed, or used in the country. Registration helps protect public health and patient safety by ensuring that only approved, compliant devices are available for use in healthcare settings.