The procedures for applying for Class A medical device registration with Indonesia's Ministry of Health (MOH) involve a series of steps to ensure compliance with local regulatory requirements. These procedures are designed to confirm that the medical device is safe and effective for use in Indonesia, even for low-risk devices like Class A. Below is a step-by-step guide for applying for Class A medical device registration with the Indonesian Ministry of Health (MOH).

Step 1: Appoint a Local Authorized Representative

If you are a foreign manufacturer, you must have a local authorized representative or distributor in Indonesia to submit the registration application on your behalf. The local representative will handle communication with the Indonesian authorities, including the Ministry of Health and the National Agency of Drug and Food Control (BPOM).

• Role of Local Representative: The local representative is responsible for submitting the application, ensuring compliance with Indonesian regulations, and acting as the point of contact with regulatory bodies.

Step 2: Prepare the Required Documentation

You need to gather and prepare the following documentation for submission:

1. Manufacturer's Authorization Letter: A letter from the manufacturer authorizing the local representative or distributor to submit the application for registration.

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

3. Technical Documentation: This should include:

   • Product description (including intended use, specifications, and functions).
   • Compliance with applicable standards, such as ISO 13485 or other recognized quality management systems.
   • Risk management documentation, including assessment of potential risks associated with the device.

4. Quality Management System (QMS) Certificate: Proof of the manufacturer’s compliance with an internationally recognized QMS, such as ISO 13485.

5. Labeling and Instructions for Use (IFU): All product labels and IFU must be in Bahasa Indonesia and comply with local regulatory requirements. Ensure that they are clear and accurate for the Indonesian market.

6. Product Classification Confirmation: The device must be classified as Class A (low-risk) according to Indonesian regulations. Make sure your device meets the criteria for Class A, which involves minimal risk to patients and users.

7. Indonesian National Standards (SNI) (if applicable): Ensure that the device complies with SNI standards for medical devices if required.

Step 3: Submit the Registration Application via e-Registration

Once you have all the required documents, you can proceed to submit the application for registration through the e-Registration system provided by Indonesia's Ministry of Health or BPOM (National Agency of Drug and Food Control).

• Access the e-Registration System: The local authorized representative needs to register on the official BPOM website or the Ministry of Health’s registration portal.
• Create an Account: Create an account for the representative on the e-Registration portal if they don't already have one.
• Fill Out the Application Form: Complete the online registration form, providing detailed information about the device, including its classification (Class A), intended use, product specifications, and manufacturing details.
• Upload Supporting Documents: Upload all the necessary documents, such as:
  • Manufacturer’s Authorization Letter.
  • Certificate of Free Sale (CFS).
  • Quality Management System Certificate (ISO 13485).
  • Labeling and IFU.
  • Technical documentation.

Step 4: Review of Documents by BPOM/MOH

After submission, the MOH or BPOM will begin reviewing the application and supporting documents to ensure they meet all regulatory requirements.

• Document Evaluation: BPOM or MOH will evaluate the submitted documents for completeness, accuracy, and compliance with Indonesian standards.
• Device Assessment: They will review the technical documentation, risk management plan, labeling, and any other required materials to confirm the device meets safety, quality, and efficacy standards.
• Compliance Check: Ensure that the device complies with Indonesian regulations, such as SNI (Indonesian National Standards), and meets the criteria for Class A classification.

If any additional information or clarification is needed, BPOM/MOH will contact the local representative or distributor.

Step 5: Issuance of Izin Edar (Distribution License)

Once the application is approved, the Indonesian Ministry of Health (MOH) will issue an Izin Edar, which is the official distribution license. This license allows the device to be marketed and distributed in Indonesia.

• Certificate of Registration: In addition to the Izin Edar, the device will receive a Certificate of Registration, confirming that it is authorized for sale in Indonesia.
• Validity Period: The Izin Edar is typically valid for 5 years.

Step 6: Importation and Distribution

With the Izin Edar in hand, the local distributor or representative can begin importing and distributing the medical device within Indonesia. Make sure the device complies with all importation regulations, including:

• Compliance with Labeling Requirements: Ensure that product labeling, packaging, and Instructions for Use (IFU) are in Bahasa Indonesia.
• Importation Compliance: The device must comply with Indonesian import regulations and be properly documented for customs.

Step 7: Post-Market Surveillance (PMS)

Once the device is on the market, it is important to maintain post-market surveillance to monitor the device’s performance and safety.

• Adverse Event Reporting: If any adverse events or issues related to the device arise, they must be reported to the Ministry of Health and BPOM.
• Periodic Monitoring: Ensure regular monitoring and quality checks to identify potential safety or quality issues that may arise post-market.

Step 8: Renewal of Registration

The Izin Edar is valid for 5 years, after which the device’s registration must be renewed. The renewal process is similar to the initial application and involves submitting updated documentation and, if necessary, new post-market surveillance data.

• Start Early: Begin the renewal process at least 6 months before the Izin Edar expires to avoid any disruption in the device’s ability to be marketed and distributed in Indonesia.

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

1. Appoint a Local Authorized Representative: A local distributor or representative must submit the application if the manufacturer is not based in Indonesia.
2. Prepare the Required Documents: Gather all necessary documentation, including the Certificate of Free Sale, ISO 13485 certification, technical documentation, labeling, and instructions in Bahasa Indonesia.
3. Submit the Application via e-Registration: Submit the completed application through the BPOM or Ministry of Health’s e-Registration portal.
4. Document Review by BPOM/MOH: BPOM or MOH will review the application, technical documents, and labeling for compliance.
5. Issuance of Izin Edar: Once approved, BPOM/MOH will issue the Izin Edar (distribution license) and Certificate of Registration.
6. Importation and Distribution: The device can now be imported and distributed in Indonesia, provided all regulatory requirements are met.
7. Post-Market Surveillance: Monitor the device’s performance and safety, reporting any adverse events to the authorities.
8. Renewal of Registration: Apply for renewal of the Izin Edar after 5 years.

By following these steps, you can successfully apply for Class A medical device registration in Indonesia and bring your product to market.