To process Class A medical device registration with Indonesia’s Ministry of Health (MOH), you need to follow a series of steps to ensure compliance with local regulatory requirements. Class A medical devices are considered low-risk and typically have a simpler registration process compared to higher-risk devices. Below is a step-by-step guide to processing Class A medical device registration with the Indonesian Ministry of Health (MOH).

Step 1: Ensure Eligibility and Appoint a Local Authorized Representative

Before starting the registration process, make sure your device qualifies as a Class A medical device under Indonesian regulations. For a Class A device, you must either:

1. Have a local authorized representative or distributor in Indonesia, if you are a foreign manufacturer. This representative will handle all communications and submit the application on your behalf.
2. Be aware of the device’s compliance with local regulations such as safety, labeling, and quality management system standards.

Step 2: Prepare the Required Documentation

The following documents are necessary for the registration process:

1. Manufacturer’s Authorization Letter: A letter from the manufacturer authorizing the local distributor or representative to act on their behalf for registration purposes.

2. Certificate of Free Sale (CFS): A certificate issued by the regulatory authority of the manufacturer’s home country, confirming that the medical device is legally marketed and sold there.

3. Technical Documentation:

   • Product description (including its intended use, specifications, and function).
   • Risk management plan and assessment (if applicable).
   • Compliance with international standards (e.g., ISO 13485 or equivalent).

4. Quality Management System (QMS) Documentation: Proof that the manufacturer follows a recognized quality management system (usually ISO 13485 certification).

5. Labeling and Instructions for Use (IFU): Product labeling must comply with Indonesian regulations, including being in Bahasa Indonesia. The Instructions for Use (IFU) must be clear and understandable.

6. Risk Profile and Device Classification: Confirm the classification of the device as Class A (low-risk) in Indonesia and ensure the device complies with Indonesian National Standards (SNI) if applicable.

Step 3: Submit the Registration Application via e-Registration System

Submit the completed application and documentation through the e-Registration system. The Indonesian Ministry of Health (MOH) or BPOM (Indonesian National Agency of Drug and Food Control) handles the registration process. The application form will be available online on the Ministry of Health's or BPOM’s official portal.

1. Register for an Account: Your local distributor or authorized representative must first create an account on the e-Registration platform.
2. Fill in Application Forms: Complete the online application form, providing detailed information about the device, including its intended use, manufacturer details, and technical specifications.
3. Upload Documents: Upload all required documents, including the technical data, Certificate of Free Sale (CFS), ISO certification, labeling, and any other required materials.

Step 4: Document Review and Evaluation

Once the application is submitted, the Ministry of Health or BPOM will begin evaluating the application and supporting documentation. The review typically includes:

1. Assessment of Technical Documents: The MOH will check that the technical documentation, quality management system, labeling, and risk management documents comply with Indonesian regulations.
2. Verification of Manufacturer’s Authorization: Ensure the local distributor has been authorized to submit the application on behalf of the manufacturer.
3. Review of Product Labeling and IFU: The MOH will verify that product labels and instructions are in Bahasa Indonesia and comply with local language and regulatory requirements.

For Class A devices, this review process is generally quicker compared to higher-risk devices, but it can still take several weeks.

Step 5: Approval and Issuance of Izin Edar (Distribution License)

Once the review is completed and the application is approved, the Izin Edar (Distribution License) will be issued. This is the official permit that allows you to market and distribute the medical device in Indonesia.

• Issuance of Izin Edar: After approval, the device will receive a Certificate of Registration. The Izin Edar is valid for 5 years, after which you must apply for renewal.
• Distribute the Device: Once registered, the device can be legally imported, distributed, and sold in Indonesia.

Step 6: Post-Market Surveillance and Compliance

After your Class A medical device is registered and distributed, you must comply with Indonesian post-market surveillance (PMS) requirements:

1. Adverse Event Reporting: Report any adverse events or product-related issues to the Indonesian Ministry of Health and BPOM.
2. Safety Monitoring: Continue to monitor the safety and performance of the device once it's on the market.
3. Quality Assurance: Follow up with regular inspections and quality checks as required by Indonesian regulations.

Step 7: Renewal of Registration

The Izin Edar is valid for 5 years. To continue marketing the device after this period, you must apply for the renewal of the Izin Edar.

• Start Early: Begin the renewal process 6 months before the expiration of the current registration to ensure continuity in your ability to distribute the device.
• Update Documents: If there have been any changes to the device or its labeling, the updated documents will need to be submitted.

Summary of Steps for Class A Medical Device Registration with Indonesia MOH

1. Prepare Documents: Gather the necessary documentation, including the Certificate of Free Sale, technical documentation, ISO 13485 certification, labeling in Bahasa Indonesia, and authorization letter.
2. Appoint Local Representative: Appoint a local distributor or authorized representative in Indonesia if you are a foreign manufacturer.
3. Submit Application via e-Registration: Complete and submit the online registration application through the MOH or BPOM’s system.
4. Document Review: The MOH will review the technical documents and application for completeness and compliance with Indonesian regulations.
5. Issuance of Izin Edar: Once approved, the device will receive the Izin Edar, allowing you to distribute the device in Indonesia.
6. Post-Market Surveillance: Monitor the device's performance in the market and comply with reporting requirements.
7. Renewal: Apply for renewal of the Izin Edar after 5 years.

By following these steps, you can successfully register a Class A medical device with Indonesia’s Ministry of Health and gain access to the Indonesian market.