Applying for Class A medical device registration with Indonesia's Ministry of Health (MOH) involves several steps. Below is a detailed guide:

1. Understand Regulatory Requirements

• Ensure your device is classified as Class A (low-risk) according to Indonesia's classification system.
• Review relevant regulations, including Peraturan Menteri Kesehatan (Permenkes) and Indonesia’s Ministry of Health guidelines.

2. Appoint a Local Authorized Representative

• Non-Indonesian companies must appoint a local distributor or representative who is registered with Indonesia MOH.
• The representative will act as the license holder for the device.

3. Prepare the Required Documentation

Collect the following essential documents:

• Product Dossier:
  • Device description
  • Intended use
  • Classification justification
  • Technical specifications
• Test Reports:
  • Safety and performance testing
  • Biocompatibility testing (if applicable)
• Certificate of Conformity:
  • ISO 13485 or equivalent quality management certification
  • Free Sale Certificate (FSC) or equivalent from the country of origin
• Labeling Information:
  • Labels must be in Bahasa Indonesia and include the device name, model, and intended use.
• Instruction for Use (IFU):
  • Translated into Bahasa Indonesia.
• Risk Analysis and Mitigation Measures:
  • Include compliance with applicable standards (e.g., ISO 14971 for risk management).

4. Submit Application via MOH Online Portal (ASPAK)

• Create an account on the ASPAK (Sistem Perizinan Alat Kesehatan) platform.
• Your local representative submits the required documentation electronically through ASPAK.

5. Pay the Registration Fee

• Fees depend on the device type and classification.
• Payment details will be provided in the ASPAK system.

6. MOH Review Process

• The MOH reviews the submitted documents for compliance.
• Class A devices generally undergo a simpler review process compared to higher-risk classes.
• Any additional queries or document requests must be addressed promptly.

7. Obtain the Distribution License (Izin Edar)

• If approved, the MOH issues the device registration certificate (Izin Edar).
• This license allows the product to be imported, marketed, and distributed in Indonesia.

8. Post-Market Obligations

• Maintain compliance with post-market surveillance requirements.
• Address any adverse events or recalls promptly.
• Renew the license as required (usually every 5 years).

Notes

• The entire process typically takes 1-3 months for Class A devices, provided all documentation is complete and accurate.
• Local representation and adherence to Bahasa Indonesia requirements are critical for a smooth process.