In Indonesia, the application for B-class medical device registration is handled by the Indonesian Food and Drug Authority (BPOM), which operates the regulatory framework for medical devices under the Ministry of Health (MOH).

To apply for B-class medical device registration, you need to use the BPOM's online e-Registration system. This system is designed for submitting applications, tracking the status, and managing documentation related to medical device registration.

Where to Apply: BPOM's e-Registration System

1. BPOM's e-Registration Portal:

• The official platform for medical device registration in Indonesia is BPOM's e-Registration Portal.
• This system allows you to submit and manage your registration application, including uploading required documents, paying registration fees, and tracking the status of your application.

Accessing the e-Registration Portal:

• The BPOM e-Registration portal is accessible online. To apply for B-class medical device registration, you need to create an account on this platform and then submit your application.

  • e-Registration Portal Link: https://eservice.pom.go.id (this is the official BPOM e-Registration portal for medical device applications).

2. Registration Process via e-Registration Portal:

• Step 1: Register an account and log in to the portal.
• Step 2: Fill out the necessary application form for the B-class medical device.
• Step 3: Upload required documents, such as product details, certificates (e.g., Free Sale Certificate, Manufacturing License), clinical data (if needed), and other supporting documents.
• Step 4: Pay the registration fees through the portal.
• Step 5: Submit the application and await BPOM’s review and approval.

3. Local Authorized Representative (for Foreign Manufacturers):

• If you are a foreign manufacturer, you must have a local authorized representative in Indonesia to handle the registration on your behalf.
• The authorized representative must be registered with BPOM and can submit the application through the same portal.

Additional Information for B-Class Medical Device Registration:

• Required Documents: Make sure that you have all necessary documents ready for submission (e.g., Free Sale Certificate, Manufacturing License, product labeling, etc.). BPOM may also request additional information or testing results depending on the nature of the device.
• Application Fee: You will need to pay the registration fee during the application process via the portal.
• Submission Deadline: There is no specific deadline for submitting your application, but it’s important to ensure all documentation is complete to avoid delays in processing.

Contact BPOM for Assistance:

If you have questions about the process, fees, or specific requirements for your device, you can contact BPOM for clarification:

• BPOM Official Website: https://www.pom.go.id
• BPOM Contact Information: BPOM provides contact details on their website for support and inquiries related to medical device registration.

By using the BPOM's e-Registration portal, you can efficiently apply for B-class medical device registration and track your application status in real time.

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