The processing time for Class I medical device registration with the Indonesia Ministry of Health (MOH), through the BPOM (National Agency of Drug and Food Control), is generally faster compared to higher-risk classes (Class II and III). However, the exact duration can vary depending on several factors such as the completeness of the application, BPOM’s workload, and any additional requirements or clarifications needed. Below is an estimated timeline and explanation of the process:

Estimated Processing Time for Class I Medical Device Registration

1. Submission and Acknowledgment:

   • Once the local authorized representative (AR) submits the application through BPOM's e-RD system, BPOM will acknowledge receipt of the application.
   • The initial acknowledgment is typically received within 1-2 working days after submission.

2. Document Review and Evaluation:

   • BPOM will begin the document review process. This includes verifying that all required documents are in place and compliant with Indonesian regulations (e.g., manufacturer information, device description, Certificate of Free Sale (CFS), labeling in Bahasa Indonesia).
   • Class I devices, being lower risk, typically undergo a simplified review process.
   • The review time for Class I medical device registrations is typically 2-4 weeks after submission. If the application is complete and there are no issues, BPOM will issue the approval within this timeframe.

3. Approval or Request for Additional Information:

   • If BPOM finds that the application is complete and in compliance, they will approve the registration and issue a registration certificate.
   • If there are any issues or missing documents, BPOM will notify the local AR and request clarifications or additional documentation. This may extend the processing time by an additional 1-2 weeks or more, depending on how quickly the additional information is provided.

4. Issuance of Registration Certificate:

   • After the application is approved, BPOM will issue the medical device registration certificate.
   • The final certificate is usually issued within 1-2 weeks after the application has been approved.

Total Estimated Processing Time:

• 2 to 6 weeks (approximately 1 to 1.5 months) from the submission date if the application is complete and there are no significant issues.
• Up to 8 weeks if BPOM requests additional documents or clarifications.

Factors That May Affect Processing Time:

• Completeness of the Submission: If all required documents are provided and correct from the outset, the process will be faster. Missing or incorrect information can lead to delays.
• Volume of Applications: BPOM’s workload can impact the processing time. During busy periods, such as year-end, delays might occur.
• Compliance with Local Regulations: Any discrepancies in labeling or packaging, such as failure to provide the label in Bahasa Indonesia, could result in delays.
• Device-Specific Issues: While Class I devices typically do not require clinical trials, any additional technical or performance data required for more complex devices might slow down the process.

Post-Approval Considerations:

• Once approved, the registration certificate is valid for 5 years. After this period, a renewal application will be needed to maintain the device's registration.

Summary of Processing Time:

• Normal Processing Time: 2 to 6 weeks for Class I devices.

• With Delays/Requests for Additional Information: Up to 8 weeks or more, depending on the situation.

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