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. Here’s a breakdown of the typical timeline:

Factors Influencing the Timeline:

1. Completeness of the Application:

   • If the application is complete and all required documents are in order, the process is likely to be faster. Missing or incomplete documents can lead to delays as BPOM will need to request additional information.

2. Device Complexity:

   • The more complex the device (e.g., if it involves clinical data or technical evaluations), the longer the review process may take. BPOM may need additional time to assess the safety, efficacy, and regulatory compliance of the device.

3. BPOM’s Workload:

   • The volume of applications BPOM is processing at the time can affect processing times. If there is a backlog of registrations, it may take longer for the device to be reviewed and approved.

4. Responsiveness of the Applicant:

   • If BPOM requests clarification or additional documentation, the speed at which the applicant responds can impact the total processing time. Prompt responses will lead to quicker approval.

Typical Timeline Breakdown:

1. Document Submission and Initial Review: (1-2 months)

   • BPOM reviews the submitted documents for completeness and compliance with the regulatory requirements. This may involve checking the technical documents, risk assessments, and certifications.

2. Technical and Safety Evaluation: (1-2 months)

   • BPOM may require additional time for evaluating the device's safety and performance, especially for more complex or high-risk devices. If clinical trials or other performance data are necessary, this can take longer.

3. Approval and Issuance of Surat Izin Edar (SIE): (1-2 months)

   • If BPOM is satisfied with the documentation and evaluation, they will issue the Surat Izin Edar (SIE), which is the official market authorization for the device.

Summary:

• Total Time: 2-4 months is typical, but it could take longer depending on the complexity of the device and the completeness of the submission.

In order to expedite the process, it’s important to ensure that the application is complete, accurate, and complies with all of BPOM's requirements.

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