The time it takes to obtain Class 3 medical device registration with the Indonesian Ministry of Health (MOH) and Badan Pengawas Obat dan Makanan (BPOM) generally ranges from 6 to 12 months, but it can vary depending on several factors, including the complexity of the device, completeness of the submission, and BPOM's workload. Here's a breakdown of the typical time cycle:

Stages and Timeline for Class 3 Medical Device Registration

1. Preparation of Documents (1–2 months)

   • Before submitting the application, you need to gather and prepare all required documentation, such as clinical data, risk management reports, GMP certificates, performance testing results, labeling, and other regulatory documents.
   • This stage depends on how quickly you can prepare and finalize the necessary paperwork. If you're working with a local authorized representative or distributor, this step can take 1 to 2 months.

2. Initial Submission and Document Review (2–3 months)

   • Once the application is submitted via BPOM’s e-registration system, BPOM begins reviewing the documentation for completeness.
   • BPOM checks whether all required documents are submitted and ensure they meet the regulatory standards.
   • During this time, BPOM may request additional information or clarification, which can add time to the review process.

3. Evaluation of Clinical Data and Testing (3–4 months)

   • BPOM will assess the clinical data, performance testing results, and other safety-related documentation to ensure the device meets the required standards for safety and efficacy.
   • For Class 3 devices, this process is more thorough and may involve expert consultation or additional information gathering.
   • If the device is already marketed in other countries, BPOM may consider foreign clinical trial data or post-market surveillance data. This can potentially shorten the time frame, but the review will still be detailed.

4. GMP Compliance and Inspection (if applicable) (1–2 months)

   • If the device is manufactured outside Indonesia, BPOM may require an inspection of the manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP).
   • Depending on the location of the manufacturing site and the availability of inspectors, this inspection can take 1 to 2 months or longer.
   • If the manufacturer already has GMP certification from a recognized authority (e.g., US FDA, EU), BPOM may expedite the process.

5. Final Review and Approval (1–2 months)

   • After all documentation is reviewed and inspections (if any) are completed, BPOM will conduct the final assessment.
   • BPOM will issue a registration certificate if the device meets all requirements. This usually takes 1 to 2 months.
   • Once the certificate is granted, the device can be marketed and distributed in Indonesia.

Factors That Can Impact the Timeline

Several factors can influence the length of the registration process for a Class 3 device:

• Completeness of the Application: If the application is incomplete or lacks necessary documentation, BPOM may request additional information, which can delay the process.

• Device Complexity: Class 3 devices typically involve more detailed documentation and data (e.g., clinical trials, performance testing), which can extend the review time.

• Foreign Manufacturer Inspections: If your device is manufactured outside Indonesia, BPOM may request an inspection of the manufacturing facility to ensure it complies with GMP. This could add additional time if the inspection is needed.

• BPOM’s Workload: The overall timeline may vary depending on BPOM’s current workload and how many other devices are undergoing review at the same time.

Typical Total Time for Registration:

• 6 to 12 months from the time the application is submitted to the receipt of the registration certificate.

• Quickest Scenario: If all documents are complete and the device is already marketed in other countries with acceptable data, the process could take closer to 6 months.

• Longest Scenario: If BPOM requests additional information or conducts a manufacturing site inspection, the process could extend closer to 12 months or more.

Tips to Accelerate the Process:

• Ensure Complete Documentation: Submit a complete and accurate set of documents to avoid delays due to missing or incomplete information.
• Work with an Experienced Local Representative: Having a local authorized representative familiar with BPOM’s requirements can help streamline the process and avoid common pitfalls.
• Prepare for GMP Inspection: If your manufacturing facility is outside Indonesia, ensure that your facility complies with Good Manufacturing Practices and is prepared for inspection.

If you need more guidance on how to prepare for registration or how to navigate the process, feel free to ask!

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