The time it takes to obtain B-class medical device registration in Indonesia with the Ministry of Health (MOH) and BPOM generally ranges from 2 to 4 months. However, this can vary depending on several factors.

Ongoing Monitoring: Once the B-class medical device is registered and approved by BPOM, manufacturers and distributors must engage in post-market surveillance. This means monitoring the performance of the device in the market to ensure that it continues to meet safety and efficacy standards.

Official Approval: The Surat Izin Edar (SIE) issued by BPOM is a legal certification allowing the device to be marketed and sold in Indonesia. Without this approval, it is illegal to distribute medical devices in the country.

If the submitted application is complete and all required documents are in order, the processing time is generally quicker. Incomplete applications or missing documents can lead to delays as BPOM will need additional information.

B-class medical device registration in Indonesia refers to the regulatory process for registering moderate-risk medical devices with the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM) in Indonesia. These devices are subject to a specific regulatory framework that ensures they meet safety, efficacy, and quality standards before being marketed or distributed in Indonesia.

To register and apply for B-class medical device registration in Indonesia with the Ministry of Health (MOH), through the National Agency of Drug and Food Control (BPOM), you need to follow a structured process.

The process for B-class medical device registration in Indonesia, overseen by the Ministry of Health (MOH) through the National Agency of Drug and Food Control (BPOM), involves several key steps. B-class devices are considered moderate-risk medical devices, and their registration requires detailed documentation to ensure safety and efficacy.

Handling the registration of B-class medical devices in Indonesia with the Ministry of Health (MOH) through the National Agency of Drug and Food Control (BPOM) involves several detailed steps. The registration process can be complex, but with the right preparation and understanding of regulatory requirements, you can successfully navigate the process.