Requirements for Class A Medical Device Registration with Indonesia MOH

Registering a Class A medical device in Indonesia involves meeting specific administrative, technical, and procedural requirements set by the Ministry of Health (MOH). Below is a breakdown of the key requirements:

1. Administrative Requirements

1. Local Authorized Representative:

   • A foreign manufacturer must appoint a local representative (distributor or regulatory consultant) registered with Indonesia's MOH. This representative acts as the legal license holder.

2. Legal Documentation:

   • Business license (SIUP or equivalent) of the local representative.
   • Tax identification number (NPWP) of the local representative.
   • Letter of appointment or authorization from the manufacturer to the local representative.

3. Certificate of Free Sale (CFS/FSC):

   • Issued by the competent regulatory authority in the country of origin.
   • Confirms that the device is legally marketed in the country of manufacture.

4. ISO 13485 Certificate:

   • Demonstrates the manufacturer's compliance with international quality management standards for medical devices.

2. Technical Documentation

1. Device Description:

   • Product name and model.
   • Description of the intended use and key features.

2. Risk Management File:

   • Risk analysis and mitigation measures per ISO 14971 standards.

3. Performance and Safety Data:

   • Test reports supporting the device’s safety and performance (e.g., electrical safety, biocompatibility, if applicable).

4. Labeling Information:

   • Labels must be translated into Bahasa Indonesia and include:
     • Device name and model.
     • Manufacturer’s name and address.
     • Local representative’s name and address.
     • Instructions for use, warnings, and precautions.

5. Instructions for Use (IFU):

   • User manuals or operating instructions translated into Bahasa Indonesia.

3. Procedural Requirements

1. Online Submission via ASPAK:

   • All documents must be uploaded to the MOH’s online registration system (ASPAK - Sistem Perizinan Alat Kesehatan).

2. Payment of Registration Fees:

   • Pay the registration fee through the MOH payment gateway. The fee varies depending on the device and classification.

3. Technical Review by MOH:

   • The MOH evaluates the documentation to ensure compliance with Indonesian regulations.

4. Language Requirements

• All documents, labels, and instructions for use must be translated into Bahasa Indonesia.

5. Regulatory Standards Compliance

• Compliance with applicable international standards, such as:
  • ISO 13485 for quality management.
  • ISO 14971 for risk management.

6. Post-Market Surveillance

• Manufacturers and their local representatives must ensure:
  • Reporting of adverse events and recalls to MOH.
  • Ongoing compliance with Indonesian regulations.

7. Validity and Renewal

• The registration certificate (Izin Edar) is valid for five years and must be renewed before expiration.

Would you like help with preparing any specific documents or understanding the submission process?

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