How to Apply for Class A Medical Device Registration with Indonesia MOH

To apply for Class A (low-risk) medical device registration with Indonesia’s Ministry of Health (MOH), follow the steps below. The application must be submitted through the official MOH registration system.

1. Steps to Apply

Step 1: Confirm Device Classification

• Verify the classification of your medical device as Class A based on Indonesia's medical device regulations.
• Refer to MOH guidelines or consult with a regulatory expert if necessary.

Step 2: Appoint a Local Authorized Representative

• Non-Indonesian manufacturers must appoint a local authorized representative (distributor or consultant) to act as the license holder.
• The representative must be registered with the MOH.

Step 3: Prepare Required Documentation

• Collect administrative and technical documents, including:
  • Manufacturer’s ISO 13485 certification.
  • Free Sale Certificate (CFS) from the country of origin.
  • Device description, labeling, and Instructions for Use (IFU) in Bahasa Indonesia.
• Translate all required materials into Bahasa Indonesia.

Step 4: Submit Application via ASPAK Portal

• Log in to the ASPAK (Sistem Perizinan Alat Kesehatan) portal:
  • URL: ASPAK Portal (official MOH portal for medical device registration).
  • Create an account if you don’t already have one.
• Fill out the application form and upload the required documents.

Step 5: Pay Registration Fee

• Follow payment instructions provided in the portal.
• Payment is typically made electronically through the system.

Step 6: MOH Review

• The MOH will evaluate the submitted application. They may request additional information or clarifications during this stage.

Step 7: Receive Approval

• Once approved, the MOH issues an Izin Edar (Distribution License), valid for five years.

2. Where to Apply

• Online Platform: Applications are submitted online via the ASPAK portal.
• Authorized Representative: Applications are submitted through the account of your appointed local representative.

Key Tips

1. Ensure Document Accuracy: Double-check all documents for consistency.
2. Use Certified Translators: All documents must be translated into Bahasa Indonesia, and poor translations can delay approvals.
3. Timely Follow-Ups: Monitor the application status on the ASPAK portal and respond promptly to any MOH inquiries.

If you need guidance on any specific part of the application process or document preparation, feel free to ask!

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