To register and apply for D-class medical device registration in Indonesia through the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM), you need to follow a systematic process. D-class devices are considered low-risk medical devices, and while the process is relatively simpler compared to higher-risk categories, it still requires attention to detail and adherence to regulatory standards.

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

Step 1: Verify Device Classification

Ensure that your medical device falls under D-class as defined by Indonesian regulations. D-class devices are typically low-risk, non-invasive devices that do not pose significant health risks.

• Examples of D-class devices include: non-sterile bandages, simple diagnostic tools, or devices with low risk in their intended use.
• Classification Reference: Check the Indonesian Medical Device Regulations (BPOM’s medical device classification) to confirm the device's classification. If you are unsure, you may need to consult BPOM or seek expert advice.

Step 2: Prepare Required Documentation

The following documentation is required for D-class medical device registration in Indonesia:

1. Product Information:

   • Device name, brand, and model.
   • Manufacturer’s name and address.
   • Product description, including intended use and function.

2. Manufacturing Information:

   • Certificate of Free Sale (CFS) from the country of origin (demonstrating the product is legally sold in the manufacturer's home country).
   • ISO 13485 (or equivalent) certification for the manufacturer’s quality management system (mandatory for most medical devices but may not be required for very basic D-class devices).

3. Technical Documentation:

   • Performance test results, such as electrical safety tests, biological evaluation, and any other necessary tests based on the device type.
   • Risk assessment for the device, demonstrating how it meets safety standards.
   • Clinical evidence (if applicable), though this is usually not required for low-risk D-class devices.

4. Labeling Information:

   • Label in the Indonesian language containing product name, manufacturer name, usage instructions, and expiration date (if applicable).
   • Instructions for Use (IFU) in Indonesian, detailing the proper usage, precautions, and any warnings associated with the device.

5. Registration Application Form:

   • Complete BPOM’s registration form for medical devices, which can be done online via the BPOM e-Registration system.

Step 3: Register on BPOM’s e-Registration System

To submit your application, you need to create an account on BPOM’s e-Registration portal:

1. Create an Account: Visit the BPOM e-Registration portal (https://e-reg.bpom.go.id).
2. Login and Profile Creation: If you are a foreign manufacturer, ensure that you have a local distributor or authorized representative in Indonesia. This entity will submit the application on your behalf.
3. Enter Required Information: Fill in necessary information about the device, the manufacturer, and the intended use.

Step 4: Submit the Application Online

1. Login to the e-Registration portal with your credentials.
2. Upload Required Documents: Submit all the required documents such as product information, certificates, performance test results, risk assessment, and labeling details.
3. Complete the Registration Form: The form will ask for detailed information about the device, its intended use, and its regulatory status.
4. Pay Registration Fees: Pay any applicable fees for the registration process (BPOM charges fees based on the device category).

Step 5: BPOM Review and Evaluation

After submitting the application, BPOM will conduct a thorough review:

1. Document Verification: BPOM will verify that all necessary documents are submitted and complete.
2. Technical Evaluation: BPOM will assess the performance data, safety, and risk assessment of the device. For D-class devices, this typically involves reviewing the safety of materials, device performance, and compliance with Indonesian standards.
3. Labeling and IFU Review: BPOM will check that the product’s labeling and instructions for use comply with Indonesian language and regulatory standards.

Step 6: Respond to BPOM’s Queries (if applicable)

• If BPOM finds any gaps or needs further clarification regarding the documents or the product, they will request additional information or documentation.
• Respond promptly to any requests from BPOM to avoid delays in the registration process.

Step 7: Approval and Registration Certificate

If BPOM approves your application, they will issue the registration certificate. This certificate includes:

• Device registration number.
• Product details (device name, model, manufacturer).
• Validity period (typically 5 years for D-class devices).

This registration certificate is required for legal sale and distribution of the device in Indonesia.

Step 8: Importation and Distribution

Once the registration certificate is issued:

1. Importation: The registered device can be imported into Indonesia.
   • If you are a foreign manufacturer, the local distributor will handle the importation.
2. Post-market Surveillance: The registered device is subject to post-market surveillance by BPOM. Any adverse events, device failures, or safety concerns must be reported to BPOM.

Step 9: Renewal of Registration

The registration for D-class medical devices in Indonesia is valid for 5 years. You must submit a renewal application before the registration expires:

1. Update Required Documents: If necessary, submit updated documentation like post-market surveillance reports, updated certificates, etc.
2. Submit Renewal Application: Follow the same registration process to renew your device’s registration.

Key Points to Remember:

• Local Distributor: If you're a foreign manufacturer, you must have a registered local distributor or authorized representative in Indonesia.
• Registration Timeline: The process typically takes 3 to 6 months for D-class devices, depending on the completeness of the application and the workload at BPOM.
• Device Class: Make sure that your device is correctly classified as D-class before applying. Misclassification can delay the process.
• Compliance with BPOM Regulations: Ensure that all labeling and documentation comply with Indonesian language requirements.

Summary of Steps to Register D-Class Medical Device in Indonesia:

1. Verify device classification as D-class.
2. Prepare required documents: product information, technical documents, manufacturing certificates, labeling.
3. Register on BPOM’s e-Registration system.
4. Submit the application online with all necessary documents and fees.
5. BPOM review: BPOM evaluates the submitted materials.
6. Respond to queries: Provide additional information if required.
7. Receive registration certificate upon approval.
8. Import and distribute the device in Indonesia.
9. Renew registration after 5 years.

Following these steps and ensuring all your documentation is correct will help ensure a smooth registration process for your D-class medical device in Indonesia.

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