The time it takes to obtain D-class medical device registration in Indonesia through the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) typically ranges from 3 to 6 months. This timeframe may vary depending on factors such as the completeness of the application, the complexity of the device, and BPOM’s workload.

Breakdown of the Timeline:

1. Preparation of Documents:

   • Time Frame: 1-2 months (depending on how quickly the necessary documents can be gathered).
   • This phase involves preparing all required documentation, such as product information, performance test reports, Certificates of Free Sale (CFS), labeling in Indonesian, and other regulatory documents like ISO 13485 certification.

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

   • Time Frame: 1-2 weeks.
   • Once the documents are ready, the application is submitted through BPOM’s e-Registration portal. The time taken here is usually quick, as it mainly involves uploading the files to the online system.

3. BPOM Review and Evaluation:

   • Time Frame: 2-3 months.
   • BPOM will review the submitted application and documents. This process includes ensuring the device meets regulatory standards for safety, quality, and effectiveness. If any additional information is required, BPOM may request clarifications, which could delay the process.

4. Response to BPOM's Requests (if applicable):

   • Time Frame: 1-2 weeks (if necessary).
   • If BPOM asks for additional documents or clarifications, the response time will affect the overall duration of the registration process.

5. Issuance of Registration Certificate:

   • Time Frame: 1-2 weeks (after the review is complete).
   • Once BPOM is satisfied with the application, they will issue the registration certificate, allowing the device to be legally marketed and sold in Indonesia.

Factors that Can Affect the Timeline:

• Completeness of Application: Incomplete or incorrect documentation can delay the process, as BPOM may require additional information.
• BPOM Workload: The time required may vary depending on BPOM's current workload, which can fluctuate, especially during peak periods or regulatory changes.
• Additional Information Requests: If BPOM needs more documentation or clarification on any part of the application, it can add extra time to the approval process.
• Device Complexity: Although D-class devices are generally low-risk, any complications in device specifications or regulatory documentation could result in delays.

Summary:

The total time to obtain D-class medical device registration in Indonesia is typically between 3 to 6 months, but this can vary depending on factors like document completeness, BPOM’s workload, and the need for additional clarifications.

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