For the registration of D-class medical devices with the Ministry of Health (MOH) in Indonesia, through the National Agency of Drug and Food Control (BPOM), the regulatory standards are aligned with international norms while also taking into account the specific requirements of the Indonesian regulatory framework.

For D-class medical device registration with the Ministry of Health (MOH) in Indonesia, through the National Agency of Drug and Food Control (BPOM), the technical documentation requirements are generally less stringent compared to higher-risk medical devices. However, you still need to provide comprehensive documentation to demonstrate that the device is safe, effective, and compliant with Indonesian regulations.

The processing time for D-class medical device registration in Indonesia through the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM) typically ranges between 2 to 6 months.

To apply for D-class medical device registration with the Indonesian Ministry of Health (MOH) through the National Agency of Drug and Food Control (BPOM), certain conditions and criteria must be met to ensure compliance with local regulations. D-class devices are classified as low-risk medical devices, so the regulatory requirements for their registration are generally less stringent compared to higher-risk devices, but they still need to meet specific conditions.

To apply for D-class medical device registration in Indonesia through the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM), you need to follow a structured process. Below are the steps on how to apply, as well as the platform where you need to submit your application.

For D-class medical device registration in Indonesia with the Ministry of Health (MOH) through the National Agency of Drug and Food Control (BPOM), specific materials and documentation are required to ensure compliance with Indonesian regulatory standards. D-class devices are typically low-risk devices, and while the registration process is generally simpler than for higher-risk devices, the submission of correct and complete documents is still essential.

Registering a D-class medical device in Indonesia involves a detailed process regulated by the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM). The process is aimed at ensuring that medical devices meet safety, quality, and performance standards before they can be marketed and sold in Indonesia.

To apply for D-class medical device registration in Indonesia, you will need to submit your application to the National Agency of Drug and Food Control (BPOM), which is the regulatory authority responsible for medical device registration in Indonesia.