To register and apply for Class A medical device registration with Indonesia's Ministry of Health (MOH), you need to follow specific procedures and meet regulatory requirements for the Indonesian market. Class A devices are considered low-risk medical devices, so the process is relatively straightforward compared to higher-risk devices, but it still involves several steps.

Here is a step-by-step guide 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. This is required because only Indonesian legal entities can submit applications to BPOM (National Agency of Drug and Food Control) or the Ministry of Health.

• Role of the Authorized Representative: The authorized representative will handle all communication with the Ministry of Health (MOH), ensure regulatory compliance, and submit the necessary documents.

Step 2: Prepare the Required Documentation

You will need to gather and prepare the following documents for your registration application:

1. Manufacturer’s Authorization Letter: This letter authorizes the local representative to act on behalf of the manufacturer and submit the registration application.

2. Certificate of Free Sale (CFS): This document, issued by the regulatory authority in the manufacturer's home country, confirms that the medical device is legally marketed and sold in that country. It is often required for registration purposes.

3. Technical Documentation: This should include:

   • A detailed description of the device (including intended use, specifications, and features).
   • Evidence of compliance with international standards such as ISO 13485 (Quality Management Systems) or any other relevant certifications.
   • Risk assessment and safety documentation (especially if required by Indonesian authorities).

4. ISO 13485 Certification: This certifies that the manufacturer follows a recognized quality management system. If the manufacturer does not have ISO 13485, they may need to provide other quality management evidence that meets Indonesian standards.

5. Labeling and Instructions for Use (IFU): Labels and IFUs must comply with Indonesian regulations, which require them to be in Bahasa Indonesia. Ensure that the product labeling is clear, accurate, and meets local language requirements.

6. Product Classification Confirmation: Ensure the device is classified as Class A (low-risk). You must confirm this classification according to Indonesian regulations, which may involve a risk-based classification system.

7. Indonesian National Standards (SNI): If applicable, the product must comply with SNI (Indonesian National Standards) for medical devices.

Step 3: Submit the Application via e-Registration System

Once the documents are ready, your local authorized representative can submit the registration application through the e-Registration system provided by the Indonesian Ministry of Health (MOH) or BPOM (National Agency of Drug and Food Control).

• e-Registration Portal: The local distributor or authorized representative needs to access the official e-Registration portal provided by BPOM or MOH.

1. Create an Account: If the local representative doesn’t have an account, they need to create one on the e-Registration system.
2. Complete the Application Form: Fill in the application form with detailed information about the product, including:
   • Device classification.
   • Manufacturer details.
   • Product description, specifications, and intended use.
3. Upload Required Documents: Upload all the documents, including:
   • Manufacturer Authorization Letter.
   • CFS (Certificate of Free Sale).
   • ISO 13485 certification.
   • Technical documentation.
   • Labels and Instructions for Use (IFU).
4. Payment of Registration Fees: In some cases, you may be required to pay a registration fee, which can be processed through the portal.

Step 4: Document Review by BPOM or MOH

Once the application is submitted, BPOM or the Ministry of Health will review the application and the supporting documents for compliance with Indonesian regulations.

• Document Evaluation: BPOM or MOH will evaluate the quality and completeness of the documents. This will include checking the technical documentation, quality management system certification (ISO 13485), product labeling, and other required documents.
• Approval or Request for Clarification: If the authorities are satisfied with the documentation, they will proceed to approve the application. If any clarification or additional documentation is needed, the local representative will be asked to submit it.

For Class A devices, the review process is typically quicker, but it may still take several weeks depending on the workload of the regulatory bodies.

Step 5: Issuance of Izin Edar (Distribution License)

Once BPOM or the Ministry of Health approves the application, they will issue the Izin Edar (distribution license), which officially allows the device to be sold and distributed in Indonesia.

• Certificate of Registration: Along with the Izin Edar, you will receive the Certificate of Registration for the device.
• Validity: The Izin Edar is typically valid for 5 years from the date of issuance.

Step 6: Importation and Distribution

With the Izin Edar (distribution license) in hand, the authorized representative can now begin importing and distributing the medical device in Indonesia.

• Compliance with Importation Regulations: Ensure the device complies with importation regulations, including customs procedures and duties.
• Labeling Requirements: Ensure that all labels, packaging, and IFUs meet the Indonesian regulatory requirements and are in Bahasa Indonesia.

Step 7: Post-Market Surveillance and Compliance

Once the device is on the market, the manufacturer and authorized representative are required to ensure post-market surveillance to monitor the safety and performance of the device.

• Adverse Event Reporting: If any adverse events or product issues arise, these must be reported to BPOM or the Ministry of Health.
• Product Quality Monitoring: Regularly monitor the device's quality and performance to ensure it continues to meet safety and efficacy standards.

Step 8: 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 registration.

• Renewal Process: The renewal process involves submitting updated documentation and any necessary post-market data.
• Start Early: Apply for renewal at least 6 months before the expiration of the Izin Edar to avoid any interruptions in the device's ability to be marketed and distributed in Indonesia.

Summary of the Registration Process

1. Appoint a Local Authorized Representative: If you are a foreign manufacturer, appoint a local distributor or representative to handle the registration process.
2. Prepare Required Documents: Gather all necessary documents, including the CFS, ISO 13485 certificate, technical documentation, labeling in Bahasa Indonesia, and product classification confirmation.
3. Submit the Application: Submit the application via the e-Registration portal provided by BPOM or the Ministry of Health, along with the required documents.
4. Document Review: BPOM or MOH will review the documents, check compliance with Indonesian regulations, and approve the application.
5. Izin Edar Issuance: Once approved, you will receive the Izin Edar (distribution license) and Certificate of Registration.
6. Importation and Distribution: The device can now be imported and distributed in Indonesia.
7. Post-Market Surveillance: Monitor the safety and performance of the device once it is on the market.
8. Renewal: Apply for renewal of the Izin Edar every 5 years.

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

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