The registration cycle for D-class medical devices in Indonesia through the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) typically takes 3 to 6 months. This duration may vary depending on several factors, including the completeness of the application, the complexity of the device, and the workload of BPOM.

Breakdown of the Registration Cycle:

1. Preparation Phase:

   • Time Frame: 1-2 months (depending on the speed of document collection and preparation).
   • This includes gathering all the required documentation, such as product information, performance data, certificates (e.g., Certificate of Free Sale, ISO 13485), labeling in Indonesian, and the technical files.

2. Submission via BPOM's e-Registration System:

   • Time Frame: 1-2 weeks.
   • After preparing the necessary documents, you will submit the application through BPOM’s e-Registration portal. The time for submission itself is quick, but BPOM will only begin the review once the application is submitted.

3. BPOM Review and Evaluation:

   • Time Frame: 2-3 months.
   • BPOM will review the application, verify that all documents are complete, and assess the safety and compliance of the device. If BPOM identifies any missing information or requires clarification, they may request additional documents, which could extend the review time.
   • For D-class medical devices, the review process is typically faster than higher-risk devices, but the time frame can still vary based on BPOM's workload.

4. Response to Clarifications (if applicable):

   • Time Frame: 1-2 weeks (if necessary).
   • If BPOM requests additional information or clarification, the manufacturer or local distributor must respond promptly to avoid delays. Any delays in response can add to the total time.

5. Issuance of Registration Certificate:

   • Once BPOM is satisfied with the application, they will issue the registration certificate, typically after completing the review. This marks the approval of the device for sale and distribution in Indonesia.

Factors that Can Affect the Registration Cycle:

• Completeness of Documentation: Incomplete or incorrect documentation can lead to delays, as BPOM may need to request additional information.
• BPOM Workload: During periods of high demand, such as regulatory changes or an influx of applications, the review process may take longer.
• Device Complexity: While D-class devices are low-risk and generally faster to process, more complex devices may require additional review time, even within the D-class category.
• Response Time: Delays in responding to any additional requests from BPOM can prolong the process.

Summary:

In general, the registration cycle for D-class medical devices in Indonesia takes about 3 to 6 months. This includes the preparation phase, submission, BPOM review, and issuance of the registration certificate. Ensuring that all documentation is complete and accurate will help expedite the process.

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