The process for applying for D-class medical device registration in Indonesia through the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM) involves a series of steps. D-class medical devices are low-risk devices and typically follow a simpler registration process compared to higher-risk devices.

Here’s a detailed breakdown of the steps to apply for D-class medical device registration in Indonesia:

Step 1: Confirm Device Classification

• Determine the Classification: Ensure that your device qualifies as a D-class medical device. D-class devices are considered low-risk (e.g., non-invasive devices, simple instruments).
• Check the Indonesian Classification Criteria: You should ensure that your device fits the criteria for low-risk (D-class) based on intended use and risk factors. If you're unsure, consult BPOM's official guidelines or classification system.

Step 2: Prepare the Necessary Documents

To apply for registration, you need to prepare several key documents that will be submitted to BPOM:

1. Product Information:

   • Device name, brand, and model.
   • Manufacturer details (name, address, country).
   • Intended use of the device.
   • A brief description of the device's function and design.

2. Technical Documents:

   • Performance data (test reports related to safety, efficacy, and biocompatibility).
   • Clinical evidence (if applicable, especially for certain low-risk devices that have clinical data supporting their performance).
   • Risk assessment: A basic risk analysis demonstrating the device's safety and low risk.

3. Manufacturing Documentation:

   • Certificate of Free Sale (CFS) or similar certification (showing that the device is legally sold in the country of origin).
   • ISO 13485 or equivalent certification (showing compliance with quality management systems; this is not always mandatory for D-class devices but can be helpful).

4. Labeling and Packaging Information:

   • Labels in Indonesian language that comply with BPOM's requirements (including the product name, manufacturer's name, expiration date, and usage information).
   • Instructions for Use (IFU) in Indonesian, with details on how to use the device, safety precautions, and warnings.

5. Registration Application Form:

   • Complete BPOM's online registration form with basic information about the device, the manufacturer, and the product's intended use.

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

• Create an Account: Go to the BPOM e-Registration portal (https://e-reg.bpom.go.id) and create an account. This portal is used to submit your registration application online.
• Prepare a Local Distributor: If you're a foreign manufacturer, you must have a local distributor or an authorized representative in Indonesia to handle the registration process on your behalf.

Step 4: Submit the Application Online

1. Login to the BPOM e-Registration system with your account.
2. Submit the Application: Upload all the necessary documents, including technical files, certificates, and labeling information.
3. Fill in the Application Form: Complete the registration form in the portal, providing all necessary details about the product and the manufacturer.
4. Pay the Registration Fee: BPOM may charge a fee for the registration process. The exact fee will depend on the device type and registration category.

Step 5: BPOM Review and Evaluation

Once your application is submitted, BPOM will review the documents you have provided. The review process includes the following:

1. Completeness Check: BPOM will verify that all required documents are submitted and complete.

   • If any documents are missing or incomplete, BPOM will request additional information or clarification.

2. Technical and Safety Evaluation: BPOM will evaluate the technical data provided to ensure the device is safe and effective.

   • This includes reviewing biocompatibility, performance testing, and other relevant safety data.

3. Labeling Compliance Review: BPOM will check that your labels and instructions for use (IFU) comply with Indonesian regulations, particularly that they are in Indonesian language and meet local health and safety requirements.

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

• If BPOM has any questions or requires additional documentation or clarification, they will notify you.
• Respond promptly to these requests to avoid delays in the approval process.

Step 7: Approval and Registration Certificate

If BPOM is satisfied with the application and documents, they will issue the registration certificate for your device.

• The certificate will include important information such as the registration number, device details, and validity period.
• With the registration certificate, the device is now approved for sale and distribution in Indonesia.

Step 8: Importation and Distribution

After receiving the registration certificate, you can proceed to import the device into Indonesia.

• Ensure that the local distributor handles the importation process and complies with BPOM's import regulations.
• You must also adhere to post-market surveillance requirements, including reporting any adverse events or product defects to BPOM.

Step 9: Renew Registration (if applicable)

The registration certificate for D-class devices is usually valid for 5 years. To continue selling the device in Indonesia after this period, you must apply for renewal before the certificate expires.

• The renewal process will be similar to the initial registration, but you will need to provide updated documentation, such as post-market surveillance reports, if required.

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

1. Confirm device classification as D-class (low-risk).
2. Prepare necessary documentation: product details, technical files, certificates, labeling, etc.
3. Register on BPOM’s e-Registration system and create an account.
4. Submit the application through the e-Registration portal, including all necessary documents and registration fees.
5. BPOM review and evaluation: BPOM will assess the completeness and compliance of your submission.
6. Respond to requests for clarification from BPOM (if needed).
7. Receive registration certificate after approval.
8. Import and distribute the device in Indonesia with the registration certificate.
9. Renew registration after 5 years to continue marketing the device.

Key Considerations:

• Local Distributor: If you're a foreign manufacturer, you must have a registered local distributor or authorized representative in Indonesia.
• Timeframe: The registration process for D-class devices typically takes 3 to 6 months, depending on the completeness of the application and BPOM's workload.
• Compliance with BPOM Regulations: Make sure that the labels, instructions for use, and all other aspects of your product meet Indonesian regulations.

By following these steps and ensuring your documents are complete and accurate, you can successfully apply for D-class medical device registration in Indonesia.