Class A Medical Device Registration with Indonesia MOH

This guide outlines the process, required documents, and key considerations for registering a Class A medical device with Indonesia’s Ministry of Health (MOH).

1. Process for Registration

Step 1: Confirm Device Classification

• Ensure the product qualifies as a Class A medical device (low risk) under Indonesia’s classification system.
• Refer to Indonesian MOH regulations or consult with a regulatory expert to verify.

Step 2: Appoint a Local Authorized Representative

• Non-Indonesian manufacturers must appoint a local authorized representative or distributor.
• The representative must be registered with MOH and will act as the license holder for the device.

Step 3: Gather Documentation

• Compile the necessary administrative and technical documents (details provided below).

Step 4: Submit Application via ASPAK

• Use the ASPAK (Sistem Perizinan Alat Kesehatan) online portal to register.
  • Log in or create an account through your authorized representative.
  • Complete the application form and upload documents.

Step 5: Pay Registration Fee

• Follow payment instructions provided in the ASPAK system.
• Fees vary depending on the device and MOH’s current fee structure.

Step 6: MOH Review

• MOH evaluates the submission for compliance with safety, quality, and labeling standards.
• The review process for Class A devices is typically faster, as they are low risk.

Step 7: Receive Distribution License (Izin Edar)

• If approved, MOH issues the Izin Edar, valid for five years, allowing the device to be legally marketed in Indonesia.

Step 8: Post-Market Compliance

• Maintain compliance with post-market requirements, including adverse event reporting and periodic updates.

2. Required Documents

Administrative Documents

1. Local Representative Documentation:
   • Business license (SIUP or equivalent).
   • Tax identification number (NPWP).
2. Letter of Appointment:
   • Authorization letter from the manufacturer to the local representative.
3. Certificate of Free Sale (CFS):
   • Issued by the regulatory authority in the country of origin, indicating the device is legally marketed there.
4. ISO 13485 Certificate:
   • Demonstrates the manufacturer’s compliance with international quality management standards.

Technical Documents

1. Device Description:
   • Product name, model, intended use, and physical characteristics.
2. Risk Management File:
   • Risk analysis and mitigation measures (per ISO 14971).
3. Performance and Safety Data:
   • Supporting test reports, if applicable.
4. Labeling:
   • Labels must include:
     • Product name and model.
     • Manufacturer and local representative details.
     • Instructions for use and warnings.
     • Labels must be translated into Bahasa Indonesia.
5. Instructions for Use (IFU):
   • User manual or operating instructions, also translated into Bahasa Indonesia.

3. Key Considerations

1. Accurate Device Classification

• Misclassifying your device can lead to delays or rejection. Seek expert advice if unsure about classification.

2. Local Language Requirements

• All labels, instructions, and application details must be translated into Bahasa Indonesia.

3. Timelines

• Registration for Class A devices typically takes 1–3 months from the date of submission.

4. Validity and Renewal

• The Izin Edar (distribution license) is valid for five years and must be renewed prior to expiration.

5. Post-Market Obligations

• Ensure compliance with post-market surveillance, including reporting adverse events and maintaining updated records.

Summary

• Process: Includes classification confirmation, local representative appointment, document preparation, ASPAK submission, fee payment, and MOH review.
• Documents: Administrative (e.g., CFS, ISO 13485, appointment letter) and technical (e.g., risk management, labels, IFU).
• Key Considerations: Ensure proper classification, compliance with Bahasa Indonesia requirements, and adherence to post-market obligations.

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