To apply for Class 3 medical device registration in Indonesia, you need to submit your application to the Badan Pengawas Obat dan Makanan (BPOM), which is the Indonesian Food and Drug Authority responsible for the regulation of medical devices.

Where to Apply:

• Badan Pengawas Obat dan Makanan (BPOM)
  • BPOM is the regulatory body overseeing medical device registration in Indonesia.
  • The BPOM office you will need to contact is in the Directorate of Medical Devices and Household Health Supplies.

Application Process:

1. Submission through BPOM's Online System (e-Registry)

   • BPOM has an e-Registry system that facilitates the submission of medical device registration applications. This is the most common method of application for medical devices.
   • The e-Registry platform is designed for local representatives (for foreign manufacturers) or direct applicants (for local manufacturers) to upload required documents for BPOM’s evaluation.

2. Submission through BPOM’s Physical Office (if needed)

   • If the online registration system is unavailable or you prefer to submit paper applications, you can submit your documents to BPOM’s physical office. The BPOM office is located in Jakarta, the capital city of Indonesia.
   • You will need to provide a complete registration dossier, including technical and clinical data, risk management files, certificates, labeling, and other documents as required.

BPOM Contact Information:

• Head Office:
  Badan Pengawas Obat dan Makanan (BPOM)
  Jl. Percetakan Negara No. 23,
  Jakarta Pusat, 10560,
  Indonesia.

• Website for e-Registry and Guidance:
  Visit BPOM's official website for more information on the online submission process, application guidelines, and updates:
  BPOM Website

  • On the website, you can find further details on the e-Registry system for medical devices and how to use it for the application process.

Steps for Applying:

1. Log into BPOM's e-Registry System: If you have an Indonesian Authorized Representative, they will need to create an account and submit the application via the BPOM e-Registry platform.
2. Submit Documents Electronically: Upload all necessary documents, including the registration dossier, clinical data, risk management file, certificates, and labeling in Bahasa Indonesia.
3. BPOM Review: BPOM will evaluate the submitted dossier and may request additional information or documentation.
4. Follow Up: Monitor the status of the application through the e-Registry system or via your local representative.

Additional Notes:

• Authorized Representative: If you are a foreign manufacturer, make sure you have appointed a local authorized representative in Indonesia to handle the application process. The representative will interact with BPOM on your behalf.
• Fees: There may be application fees that must be paid during the submission process. Check BPOM’s website or consult with your authorized representative for details.

Conclusion:

• The BPOM e-Registry system is the primary way to submit a Class 3 medical device registration application.
• If necessary, you can submit a paper application to BPOM's office in Jakarta.
• BPOM's evaluation process will take place after your submission, and they may request additional documentation or conduct inspections as needed.

If you need further assistance navigating the application or e-Registry system, feel free to ask!

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