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), a comprehensive set of documents is required to ensure that the device meets the necessary safety, efficacy, and regulatory standards.

To successfully apply for Class C medical device registration in Indonesia through the Ministry of Health (MOH), specifically BPOM (National Agency of Drug and Food Control), you need to follow a structured process, ensure all necessary documentation is provided, and take precautions to prevent delays or rejections.

To apply for Class C medical device registration in Indonesia, you will need to submit your application to the National Agency of Drug and Food Control (BPOM), which operates under the Ministry of Health (MOH). The application process is handled through BPOM’s e-Registration system.

The cost and timeline for applying for Class C medical device registration in Indonesia through 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 BPOM's workload.

To apply for Class C medical device registration in Indonesia through the Ministry of Health (MOH), specifically under the National Agency of Drug and Food Control (BPOM), you need to fulfill several documentation and regulatory requirements. Class C devices are considered high-risk devices, which means the registration process is more detailed and stringent compared to lower-risk classes.

The process for registering a Class C medical device with the Indonesian Ministry of Health (MOH), through the National Agency of Drug and Food Control (BPOM), involves several detailed steps. Class C medical devices are classified as high-risk devices, meaning they require a thorough evaluation process to ensure their safety, quality, and efficacy.

In Indonesia, medical devices are classified into four categories (Class A, B, C, D) based on their risk level, with Class C being the high-risk category. Class C devices are those that are considered to have a higher potential risk to patients and users, and therefore, they require more extensive regulatory scrutiny during the approval process.

Class C medical devices in Indonesia are considered "high risk" devices, which may require more extensive documentation and testing.