Processing Timeline for Class A Medical Device Registration with Indonesia MOH

The processing time for Class A medical device registration with Indonesia’s Ministry of Health (MOH) can vary depending on several factors, including the completeness of the application and the volume of applications being processed. However, for Class A devices (low-risk devices), the process is generally quicker compared to higher-risk classifications (B, C, D). Here's an outline of the expected timeline:

1. Pre-Submission: Document Preparation

• Timeline: 2–4 weeks
  • This includes gathering all required documents, such as the ISO 13485 certification, Certificate of Free Sale (CFS), product labeling, risk management documentation, and Instructions for Use (IFU).
  • You must also ensure that all documents are translated into Bahasa Indonesia and properly notarized (if required).
  • The process may take longer if translation or document legalization is required.

2. Submission of Application via ASPAK

• Timeline: 1–2 days
  • After all documents are ready, the application can be submitted through the ASPAK (Sistem Perizinan Alat Kesehatan) portal.
  • If you have already created an account and your local representative is registered, submission is quick.

3. MOH Review and Evaluation

• Timeline: 1–3 months (Typically 1–2 months for Class A devices)
  • After submission, the Ministry of Health (MOH) reviews the application to ensure that all required documents are in order and meet regulatory standards.
  • For Class A devices, the review time is typically 1–2 months, but it may take up to 3 months depending on factors such as:
    • Volume of applications being processed.
    • The completeness and accuracy of submitted documents.
    • Any requests for additional information or clarifications.
• Possible Delays:
  • If there are any missing documents or the application is incomplete, the MOH may request further information, which could delay the processing time.
  • Delays may also occur due to the high volume of applications.

4. Approval and Issuance of Izin Edar (Distribution License)

• Timeline: 1 week to 1 month after approval
  • Once the MOH approves the application, they will issue the Izin Edar (Distribution License), which is valid for five years.
  • The license will allow the product to be marketed and distributed in Indonesia.
  • If there are no issues, the Izin Edar is typically issued within 1 month after approval.

5. Total Estimated Timeline

• Overall Timeline for Class A Device Registration: 2–4 months
  • From the time of submitting the application to receiving approval, the total timeline is usually 2–4 months for Class A devices.
  • Key factors: Document completeness, translation accuracy, and responsiveness to MOH requests for additional information.

Key Considerations for Timeline:

• Document Completeness: Ensuring that all documents are correct and complete before submission can reduce the processing time.
• Translation: Documents must be properly translated into Bahasa Indonesia, and this can add time to the preparation stage.
• MOH Workload: During periods of high application volume (e.g., industry events, regulatory changes), processing times may be longer.
• Response to Queries: If the MOH requests additional documentation or clarifications, the clock may stop until the requested information is provided.

Summary Timeline:

• Pre-Submission (Document Preparation): 2–4 weeks
• Application Submission (via ASPAK): 1–2 days
• MOH Review and Evaluation: 1–3 months
• Issuance of Izin Edar: 1 week to 1 month

The total processing time is typically around 2 to 4 months from start to finish for Class A devices.

Let me know if you'd like further guidance on document preparation or any part of the process!

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