Procedures and Steps for Class A Medical Device Registration with Indonesia MOH

Registering a Class A medical device with Indonesia's Ministry of Health (MOH) involves a systematic process to ensure compliance with local regulations. Here are the detailed procedures and steps:

1. Understand the Regulatory Framework

• Ensure that your device qualifies as a Class A medical device (low-risk category).
• Review the applicable regulations, including:
  • Permenkes (Ministry of Health Regulations).
  • Requirements outlined by the MOH for medical device registration.

2. Appoint an Authorized Representative

• If you are a foreign manufacturer, you must appoint a local distributor or an authorized representative registered in Indonesia.
• The authorized representative acts as the license holder and is responsible for submitting the application.

3. Prepare the Required Documentation

Collect and compile the necessary administrative and technical documents:

Administrative Documents:

• Business License (SIUP or equivalent): Provided by the authorized representative.
• Letter of Appointment: Manufacturer’s authorization for the representative.
• Certificate of Free Sale (FSC): Issued by the competent authority in the manufacturer’s country.
• ISO 13485 Certificate: To prove the manufacturer’s quality management system compliance.

Technical Documents:

• Device Description:
  • Device name, model, and intended use.
• Risk Management File:
  • Risk analysis report following ISO 14971.
• Performance and Safety Data:
  • Relevant test reports for safety and efficacy.
• Labeling Information:
  • Product labels translated into Bahasa Indonesia.
• Instructions for Use (IFU):
  • User manual translated into Bahasa Indonesia.
• Clinical Evidence:
  • Not mandatory for Class A devices but may be needed for specific cases.

4. Register on the ASPAK System

• The authorized representative must log in to ASPAK (Sistem Perizinan Alat Kesehatan), the MOH’s online registration platform.
• Create an account (if not already registered).
• Complete the product details form and upload the required documents.

5. Pay the Application Fee

• Pay the prescribed registration fee through the MOH’s payment system.
• The fee amount varies depending on the product and application type.

6. MOH Review Process

• MOH will review the submitted documentation to ensure compliance with the requirements.
• For Class A devices, the review process is generally faster and less complex, as these devices are low risk.

7. Issuance of Distribution License (Izin Edar)

• Once approved, MOH will issue the Izin Edar, which is the official distribution license.
• This license allows the device to be marketed and sold in Indonesia.

8. Post-Market Compliance

• Maintain compliance with post-market surveillance regulations.
• Report any adverse events, complaints, or recalls to MOH promptly.
• Ensure that product labels and documentation remain accurate and updated.

Timeline

• The entire process for Class A device registration typically takes 1–3 months, depending on the completeness of the submission and the MOH’s workload.

Additional Tips:

• Language Requirements: Ensure that all documentation, including labels and user manuals, is translated into Bahasa Indonesia.
• Renewal: The registration is valid for five years and must be renewed before expiration.

Would you like further details on any specific step?

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