After applying for Class C medical device registration with the Indonesian Ministry of Health (MOH) and BPOM, there are several key regulations and requirements that must be followed to ensure compliance and ensure that the device remains legally marketable in Indonesia. These regulations cover aspects such as labeling, post-market surveillance, reporting, and renewing the registration.

Before applying for Class C medical device registration in Indonesia through the Ministry of Health (MOH) and BPOM, you should make several critical preparations to ensure that the process runs smoothly and that your device meets all necessary regulatory requirements.

After the registration is approved, BPOM will issue the Marketing Authorization (NOM) for your Class C medical device. This authorization allows you to legally market and distribute the device in Indonesia.

When applying for Class C medical device registration in Indonesia through the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control), the device must comply with a set of standards and regulations to ensure safety, performance, and quality. These standards primarily include international standards recognized by BPOM, Indonesian National Standards (SNI), and specific BPOM guidelines.

For Class C medical device registration in Indonesia under the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control), several technical documents are required to demonstrate that the medical device complies with the safety, performance, and regulatory requirements set by Indonesian authorities.

The processing time for Class C medical device registration in Indonesia under the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) can vary based on several factors such as the complexity of the device, the completeness of the submission, and whether any additional information or inspections are required.

To apply for Class C medical device registration in Indonesia through the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control), certain conditions must be met to ensure the device complies with Indonesia's regulatory requirements. These conditions primarily revolve around safety, efficacy, quality control, and compliance with local regulations.

To apply for Class C medical device registration in Indonesia, you will need to follow a structured process via the National Agency of Drug and Food Control (BPOM), which operates under the Ministry of Health (MOH). The registration process is done through BPOM's e-Registration System.