The processing time for B-class medical device registration in Indonesia through the Ministry of Health (MOH) and BPOM can vary depending on several factors, including the completeness of the application, the complexity of the device, and BPOM's workload. However, here is a general overview of the typical processing timeline:

Estimated Processing Time for B-Class Medical Device Registration

1. Initial Submission and Document Review:

   • Duration: Typically 2 to 4 weeks.
   • BPOM will first review the submitted application and documents to ensure they meet regulatory requirements. If the documents are complete and in the correct format, BPOM will begin evaluating them.

2. BPOM Evaluation and Request for Additional Information:

   • Duration: If additional information or documentation is required, BPOM may ask for clarifications or further data. This process can add 1 to 3 weeks to the timeline, depending on how quickly the applicant responds.
   • Note: For foreign manufacturers, BPOM may request extra documentation or even an inspection of the manufacturing facility, which can lengthen the review time.

3. Issuance of Approval (Surat Izin Edar - SIE):

   • Duration: After BPOM completes its evaluation and is satisfied with the provided documentation, they will issue the Surat Izin Edar (SIE) (marketing authorization certificate).
   • The entire approval process (from submission to receiving the SIE) can typically take 4 to 6 weeks for a well-prepared application.

4. Post-Market Requirements:

   • After approval, you must comply with post-market surveillance obligations, including adverse event reporting and annual renewal of registration. These processes will continue throughout the lifecycle of the device in the market.

Factors That Can Affect Processing Time

• Completeness of Application: If the submitted documents are incomplete or not properly translated, BPOM may request additional documents, causing delays.
• Device Complexity: Devices that are more complex or involve novel technologies may take longer to evaluate.
• Inspection or Testing: If BPOM requests a manufacturing facility inspection or testing, this can add extra time.
• Response Time: The time it takes to respond to BPOM's requests for additional information or clarifications can influence the overall processing time.

Overall Estimate:

• In general, the total processing time for B-class medical device registration in Indonesia typically takes around 6 to 8 weeks, assuming all documentation is in order and no additional complications arise.

If you are submitting an application, it's important to plan for potential delays and allow extra time for unexpected requests from BPOM.

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