The processing time for Class C medical device registration in Indonesia under 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 whether additional information or inspections are required.

In Indonesia, the classification of medical devices follows a risk-based categorization system defined by the Ministry of Health (MOH) and managed by the National Agency of Drug and Food Control (BPOM). These categories are used to determine the regulatory requirements and the level of scrutiny a medical device will undergo during the registration process. Class C refers to moderate-risk medical devices in this classification system.

If you are a foreign manufacturer, you must appoint a local authorized representative or distributor in Indonesia. This is a mandatory requirement because foreign manufacturers cannot submit an application directly to BPOM without a local representative.

The procedures for Class C medical device registration in Indonesia under the Ministry of Health (MOH), specifically through BPOM (Badan Pengawas Obat dan Makanan), involve a series of steps to ensure that the device meets all regulatory requirements for safety, quality, and effectiveness. Class C devices are categorized as moderate-risk devices, and the registration process requires more comprehensive documentation than lower-risk devices (Class A and B).

To apply for Class C medical device registration in Indonesia with the Ministry of Health (MOH) through BPOM (Badan Pengawas Obat dan Makanan), the process involves several key steps to ensure that the medical device meets the safety, quality, and regulatory standards required for the Indonesian market.

The processing time for Class C medical device registration in Indonesia through the Ministry of Health (MOH), specifically BPOM (Badan Pengawas Obat dan Makanan), typically ranges from 3 to 6 months, depending on the complexity of the device, the completeness of the application, and the need for additional clarifications or inspections.

The process for applying for Class C medical device registration in Indonesia through the Ministry of Health (MOH), specifically with BPOM (Badan Pengawas Obat dan Makanan), follows a structured series of steps designed to ensure the safety, efficacy, and quality of medical devices entering the Indonesian market. Below is a detailed breakdown of the steps involved in the registration process for Class C medical devices

The process for registering Class C medical devices with BPOM (Badan Pengawas Obat dan Makanan), the Indonesian Ministry of Health (MOH), is continually evolving to align with international best practices and ensure patient safety. The latest updates to standards and processes typically reflect changes in regulatory frameworks, evolving international guidelines (such as ISO standards), and specific updates to BPOM regulations.Here is an overview of the updated standards and processes for Class C medical device registration in Indonesia, based on the latest available guidelines and regulatory requirements.