The processing time for B-class medical device registration with the Ministry of Health (MOH) and BPOM in Indonesia typically ranges from 2 to 4 months. However, the exact duration can vary depending on several factors, including:

Factors Affecting Processing Time:

1. Completeness of the Application:

   • 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.

2. Complexity of the Device:

   • The more complex the device (e.g., involving clinical data, advanced technology, or multiple components), the longer the review process may take. BPOM may need more time for technical evaluation or to assess clinical trials, safety data, or risk management plans.

3. BPOM’s Workload:

   • The volume of applications BPOM is handling at any given time can also affect processing times. High submission volumes or internal administrative delays may extend the review process.

4. Response to Queries:

   • If BPOM raises questions or requests additional documentation, the processing time will increase based on how quickly the applicant responds.

Typical Steps and Timeframes:

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

   • BPOM will check the completeness and validity of the application and supporting documents (e.g., clinical data, ISO certificates, risk management files, etc.).

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

   • If the device requires technical or safety evaluations, such as assessing clinical data or performance testing, this can take additional time.

3. Approval or Request for Additional Information: (Variable)

   • BPOM may approve the registration or request additional information from the applicant. If additional documentation is needed, the review process will take longer.

4. Issuance of Surat Izin Edar (SIE): (After successful review)

   • Once BPOM is satisfied with the application, they will issue the Surat Izin Edar (SIE), which allows the device to be marketed in Indonesia.

Key Timeline Summary:

• Total processing time: 2-4 months, assuming the application is complete and there are no significant delays or additional requirements.

However, applicants should plan for possible delays and monitor the process through the BPOM’s e-Registration portal to ensure timely submission of additional information if needed.