The processing time for Class 3 medical device registration with the Indonesian Ministry of Health (MOH), through Badan Pengawas Obat dan Makanan (BPOM), typically ranges from 3 to 6 months. However, the exact time can vary based on several factors, including the complexity of the device, the completeness of the application, and the responsiveness of the manufacturer or authorized representative in providing additional documentation or clarifications when requested.

Key Factors Affecting Processing Time:

1. Completeness of the Application:

   • If the registration application is complete and includes all required documents (clinical data, performance test results, ISO certifications, etc.), the review process will be faster.
   • Incomplete applications may result in delays, as BPOM may request additional information or documentation.

2. Clinical Data Review:

   • Class 3 medical devices require extensive clinical data to demonstrate safety and efficacy. If the clinical data is complex or if BPOM needs additional time to review the data or conduct further analysis, this may extend the processing time.

3. Device Complexity:

   • High-risk devices such as implantable devices, electrical devices, or devices requiring extensive clinical trials may take longer for review.
   • Simpler devices (within Class 3) may undergo a quicker evaluation.

4. Response Time to Requests for Additional Information:

   • BPOM may request clarifications, additional documents, or further test reports. Delays in providing these documents can significantly extend the processing time.
   • Prompt and thorough responses to such requests can help keep the registration process on track.

5. BPOM’s Internal Workload:

   • BPOM may have varying processing times depending on the volume of applications they are handling at any given time.
   • During peak periods, the processing time may be longer.

6. Manufacturer’s Location:

   • Foreign manufacturers may experience longer processing times due to the extra steps involved (e.g., appointment of an authorized representative in Indonesia and translation of documents into Bahasa Indonesia).

Typical Timeline for Class 3 Registration Process:

1. Preparation of Documents: Depending on how quickly the necessary documentation (clinical trials, quality certificates, etc.) can be prepared, this may take a few weeks to a few months.

2. Application Submission: The application is submitted to BPOM either via the e-Registry system or in physical form. The submission itself can take 1-2 weeks, depending on the application format and whether it’s done online or offline.

3. BPOM Review and Evaluation:

   • BPOM will evaluate the documentation for completeness and compliance.
   • Clinical data and other technical documentation will be reviewed.
   • This review process typically takes 2 to 4 months, depending on the complexity of the device.

4. Additional Documentation Requests: BPOM may request more information, which could extend the timeline by an additional 2-4 weeks.

5. Approval and Issuance of Registration Certificate: Once BPOM is satisfied with the submitted documents, they will issue the registration certificate. The final approval typically takes 1 to 2 weeks after the review is complete.

Estimated Total Processing Time:

• For well-prepared applications: 3 to 6 months from submission to approval.
• For complex devices or those requiring additional data: up to 9 months or longer.

Important Considerations:

• Expedited Processing: In some cases, if the device is deemed critical for public health or there is an urgent need, BPOM may expedite the process, though this is rare.
• Post-Approval: After receiving approval, you will also need to adhere to post-market surveillance and reporting requirements, which may take additional time.

Conclusion:

The typical processing time for Class 3 medical device registration in Indonesia is around 3 to 6 months, but it can vary based on factors like application completeness, clinical data review, and BPOM’s workload. Ensuring that the application is complete and promptly responding to any BPOM requests for additional documentation can help minimize delays.

Let me know if you need assistance with specific parts of the registration process!

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