To apply for Class A medical device registration with Indonesia’s Ministry of Health (MOH), you must submit the application through the ASPAK (Sistem Perizinan Alat Kesehatan) system, which is the official online portal for medical device registration in Indonesia.

Steps to Submit the Application through ASPAK:

1. Access the ASPAK System:

   • The ASPAK portal is managed by Indonesia’s MOH and can be accessed online. To start the registration process, go to the official ASPAK website: ASPAK Portal.

2. Create an Account:

   • If you don't already have an account on ASPAK, you will need to register by providing your company’s details and the contact information of your local representative (if applicable).

3. Log in to ASPAK:

   • Once your account is set up, log in to the system using your credentials.

4. Complete the Application Form:

   • Fill in the required details about your medical device, including:
     • Device name, model, and description.
     • Intended use and risk classification.
     • Manufacturer details and local representative details.

5. Upload Documents:

   • Submit all the necessary documents (as previously mentioned), such as:
     • Free Sale Certificate (FSC)
     • ISO 13485 certificate
     • Device description, risk management file, and test reports.
     • Instructions for Use (IFU) and labels (in Bahasa Indonesia).

6. Pay the Registration Fee:

   • The system will provide payment instructions. Pay the prescribed registration fee via the available payment methods.

7. Submit the Application:

   • After uploading the documents and completing the form, submit the application for MOH review.

After Submission:

• MOH Review: The MOH will review your application and may request additional information or clarification.
• Approval: If the application is approved, the MOH will issue the Izin Edar (Distribution License), allowing the product to be marketed in Indonesia.

If you need further details on how to navigate the ASPAK portal or how to prepare your documents, feel free to ask!

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