To apply for D-class medical device registration in Indonesia with the Ministry of Health (MOH), you need to follow a structured process through the National Agency of Drug and Food Control (BPOM). D-class devices are considered low-risk medical devices, and the registration process for these devices is relatively streamlined, but it still requires thorough documentation and adherence to local regulations.

Here’s a step-by-step guide on how to apply for D-class medical device registration in Indonesia:

Step 1: Confirm Device Classification

• D-Class medical devices are low-risk and may include items like bandages, non-invasive diagnostic tools, or non-sterile devices.
• Ensure that your device qualifies as a D-class device under the Indonesian classification system. The device must meet the criteria for low-risk devices in terms of intended use and safety.

Step 2: Prepare the Required Documentation

Before submitting your application, ensure that you have all the necessary documents in order. The documents you need to prepare include:

1. Product Information:

   • Product name and brand.
   • Manufacturer details, including name, address, and registration status in the country of origin.
   • Device description: A brief description of the device, including its intended use, composition, and functionality.

2. Technical Documentation:

   • Performance data, including results from relevant safety and efficacy tests (e.g., electrical safety, biocompatibility).
   • Clinical data (if applicable), including reports on clinical trials or literature reviews to support the safety and effectiveness of the device.
   • Risk assessment for the device, showing how it meets the safety standards.

3. Manufacturing and Compliance Certificates:

   • ISO 13485 certification (for the manufacturer), or proof of a quality management system.
   • Certificate of Free Sale (CFS) or similar certificates that confirm the device is sold in the country of manufacture.

4. Labeling and Packaging Information:

   • Product label in Indonesian language, containing the product name, manufacturer, expiration date, and other essential information.
   • Instructions for Use (IFU) in Indonesian, outlining how the device should be used, potential risks, and other safety information.

5. Registration Form:

   • Complete the registration form required by BPOM. This form will request general information about the product, the manufacturer, and the intended use.

Step 3: Create an Account on BPOM’s e-Registration System

• Register on BPOM's e-Registration portal: You must create an account in BPOM's online registration system, where you will submit all documentation for device registration.
  • Access the e-Registration portal at https://e-reg.bpom.go.id.
  • Create a profile as a local representative or distributor if you're a foreign manufacturer (you’ll need a local authorized representative to handle the registration).

Step 4: Submit the Application via e-Registration System

1. Login to the e-Registration system with your account credentials.
2. Submit the application for registration by uploading all required documents, including the technical documentation, labeling, and certificates.
3. Complete the online application form, providing information about the product, manufacturer, intended use, and regulatory compliance.
4. Pay registration fees if applicable (BPOM may charge fees depending on the device and its classification).

Step 5: BPOM Review Process

Once BPOM receives your application, they will review the submitted documents. This process involves:

• Document Verification: BPOM will verify that all required documents have been provided, including performance data, compliance certificates, and labeling.
• Technical Review: BPOM will review the device's technical specifications and safety data to ensure it complies with Indonesian medical device standards.
• Labeling Compliance Check: BPOM will confirm that the labels and instructions for use (IFU) are in compliance with Indonesian regulatory requirements (e.g., use of the Indonesian language).

Step 6: Respond to BPOM’s Clarification Requests (if any)

• If BPOM finds any issues or requires clarification regarding your application, they will issue a request for additional information.
• Be prepared to promptly address any queries or provide further documentation.

Step 7: Receive Registration Certificate

• Once the BPOM review is completed successfully and your application is approved, BPOM will issue the registration certificate.
  • This certificate will contain important information, such as the registration number and product details.
  • With the registration certificate, your device can legally be marketed, imported, and sold in Indonesia.

Step 8: Import and Distribute the Device in Indonesia

• Importation: After receiving the registration certificate, you can import the device into Indonesia. Ensure that the local distributor (if you are a foreign manufacturer) handles all importation processes.
• Post-market Surveillance: Ensure that you are complying with post-market surveillance requirements, such as reporting adverse events and monitoring the device’s performance in the market.

Step 9: Renewal of Registration

• The registration for D-class medical devices in Indonesia is typically valid for 5 years.
• To continue selling the device in Indonesia, you will need to apply for renewal before the registration expires, following the same process as the initial application (updating necessary documents and paying renewal fees).

Summary of Steps to Apply for D-Class Medical Device Registration in Indonesia:

1. Confirm Device Classification: Ensure the device is categorized as D-class (low risk).
2. Prepare Documents: Gather all required technical, regulatory, and labeling documents.
3. Register on BPOM’s e-Registration Portal: Create an account and log in to submit the application.
4. Submit the Application: Upload all required documents and complete the online registration form.
5. BPOM Review: BPOM will assess the application and may request additional documentation.
6. Receive Registration Certificate: If approved, receive the registration certificate.
7. Import and Distribute: Once registered, you can import and distribute the device in Indonesia.
8. Renew Registration: Apply for renewal after 5 years to maintain registration.

Additional Notes:

• Local Representative: If you are a foreign manufacturer, you must have a registered local distributor or authorized representative in Indonesia to handle the registration process.
• Cost and Timeframe: The registration process for D-class devices typically takes 3 to 6 months, depending on the complexity of the device and the completeness of your application.

Following this process and ensuring that all the documentation is accurate and complete will help ensure a smoother and quicker registration experience for your medical device in Indonesia.

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