The cost and time required for Class I medical device registration with the Indonesia Ministry of Health (MOH) depend on several factors, including the specific device, the complexity of the application, and the efficiency of the process.

To apply for Class I medical device registration with the Indonesia Ministry of Health (MOH), you must meet specific requirements related to the device, the manufacturer, and the application process.

Classification Determination: Ensure your medical device qualifies as a Class I device, which is typically a low-risk device. Class I devices generally include non-invasive devices, such as thermometers, bandages, and gloves.

Class I medical device registration with the Indonesia Ministry of Health (MOH) refers to the process of obtaining official approval for medical devices classified as low-risk in accordance with Indonesian regulations. Class I medical devices are generally considered to pose minimal risk to patients or users, such as basic tools or equipment like thermometers, bandages, and certain diagnostic devices.

Confirm that your medical device falls under Class I, which are low-risk devices (e.g., bandages, thermometers). Class I devices have a simpler registration process compared to higher-risk classes.

The process of obtaining Class II medical device registration with the Indonesian Ministry of Health (MOH) through BPOM typically takes 3 to 6 months. The timeline can vary depending on several factors, including the complexity of the device, completeness of the submitted documentation, and BPOM’s review workload.

Class II medical device registration in Indonesia does not specifically require annual audits as part of the standard registration process. However, there are certain ongoing compliance and regulatory requirements that manufacturers must follow to maintain the validity of the registration.

Registering a Class II medical device with the Indonesian Ministry of Health (MOH) through BPOM provides several key benefits that can significantly impact the product’s marketability, legal standing, and success in Indonesia’s healthcare sector.