The time cycle for applying for Class 3 medical device registration with the Indonesian Ministry of Health (MOH) and Badan Pengawas Obat dan Makanan (BPOM) can vary depending on the complexity of the device, the completeness of your submission, and BPOM’s workload. However, the typical time frame for the entire process is generally between 6 months to 12 months, with some cases taking longer if additional information or inspections are required.

The process for applying for Class 3 medical device registration with the Indonesian Ministry of Health (MOH) and Badan Pengawas Obat dan Makanan (BPOM) involves several detailed steps. This process is designed to ensure that high-risk medical devices are safe, effective, and meet the regulatory requirements before being marketed in Indonesia.

After registering a Class 3 medical device with the Indonesian Ministry of Health (MOH) and Badan Pengawas Obat dan Makanan (BPOM), the process does not end with the initial approval. There are periodic updates, renewals, and ongoing compliance requirements that manufacturers and authorized representatives must adhere to.

After applying for Class 3 medical device MOH registration in Indonesia, manufacturers and authorized representatives must continue to follow several important regulations and requirements to ensure compliance throughout the review and approval process and post-registration period. These regulations aim to guarantee the safety, quality, and efficacy of medical devices, as well as the proper handling and distribution of medical devices once they are marketed in Indonesia.

Before applying for Class 3 medical device MOH registration in Indonesia, several critical preparation steps must be completed to ensure the process goes smoothly and meets the regulatory requirements set by the Indonesian Ministry of Health (MOH), specifically Badan Pengawas Obat dan Makanan (BPOM).

After the approval of Class 3 medical device registration by the Indonesian Ministry of Health (MOH) through Badan Pengawas Obat dan Makanan (BPOM), several key responsibilities and compliance requirements need to be followed to ensure the continued validity of the device's registration and its compliance with local regulations.

For Class 3 medical device registration in Indonesia, the following international standards and local regulatory requirements apply to ensure that the device meets safety, performance, and quality requirements. These standards are referenced by the Indonesian Ministry of Health (MOH), through the Badan Pengawas Obat dan Makanan (BPOM), during the evaluation and registration process for high-risk devices.

Device Name and Description: A detailed description of the device, including its intended use, indications, model, and any important characteristics.