To apply for D-class medical device registration in Indonesia, you will need to submit your application to the National Agency of Drug and Food Control (BPOM), which is the regulatory authority responsible for medical device registration in Indonesia.

The registration process for medical devices is handled electronically through the BPOM e-Registration System. Here are the steps and resources for applying:

1. BPOM e-Registration System

• Platform: The primary platform for submitting medical device registration applications in Indonesia is BPOM's e-Registration System.
• Website: You can access the e-Registration portal through the official BPOM website: https://www.pom.go.id.
• Online Application: All registration applications, including for D-class medical devices, must be submitted through this online system. You will need to create an account, submit required documents, pay fees, and track the progress of your application.

2. Steps for Applying via e-Registration System

A. Create an Account on e-Registration Portal

• You need to first register an account on the BPOM e-Registration portal.
• The account should be created by the local authorized representative or distributor in Indonesia, as they are the primary party responsible for the application process.

B. Prepare the Required Documents

• Gather all required documentation for the registration of the D-class medical device, including:
  • Certificate of Free Sale (CFS)
  • Product description and intended use
  • Risk classification evidence
  • ISO 13485 (if applicable)
  • Labeling and Instructions for Use (IFU) in Indonesian
  • Quality system documentation (if applicable)
• Ensure that all documents are translated into Indonesian if they are in another language.

C. Submit the Application

• Log into the e-Registration system and fill in the necessary forms for device registration.
• Upload all required documentation through the system, including the product details, certificates, and labels.
• Pay the applicable registration fee via the online payment system on the portal.

D. BPOM Review Process

• After submission, BPOM will review your application and the documents. They may request additional information or clarification.
• The review process for D-class devices typically takes 2 to 6 months, depending on the complexity of the application and BPOM’s workload.

E. Issuance of Registration Certificate

• Once the registration is approved, BPOM will issue a Certificate of Registration for your device, allowing it to be marketed and sold in Indonesia.

3. Additional Resources

• BPOM Website: https://www.pom.go.id
  • Visit the official BPOM website for more information on the e-Registration process, guidelines, and other regulatory updates.
• BPOM Helpdesk: If you have technical issues or need assistance with the e-Registration process, you can contact BPOM’s support through their website or designated helpdesk.

4. Role of Local Authorized Representative

• If you are a foreign manufacturer, you must work with a local authorized representative or distributor in Indonesia to submit the application.
• The local representative will act as the legal entity for your product in Indonesia and be responsible for the entire registration process with BPOM.

By following these steps and using the e-Registration system, you can apply for the D-class medical device registration and ensure compliance with Indonesian regulations.