To apply for Class 3 medical device registration with the Indonesian Ministry of Health (MOH), which is handled by Badan Pengawas Obat dan Makanan (BPOM), you need to follow a structured process. This includes preparing the required documentation, submitting your application, and complying with regulatory requirements. Below are the steps, requirements, and where to apply:

1. Appointment of Authorized Representative (for Foreign Manufacturers)

• Foreign manufacturers are required to appoint an authorized representative in Indonesia. This representative will be responsible for submitting the registration application and managing communication with BPOM on behalf of the foreign company.
• Local manufacturers can apply directly without the need for an authorized representative.

2. Prepare the Application Documents

Prepare a complete registration dossier, which includes:

• Device description: Product name, model, intended use, specifications, etc.
• Quality system documentation: ISO 13485 certification (Quality Management System), GMP compliance.
• Clinical data: Safety and efficacy data, clinical trial results, or post-market surveillance data.
• Performance test reports: Electrical safety, biocompatibility testing, etc.
• Certificate of Free Sale (CFS), Declaration of Conformity, and other relevant certificates.
• Labeling: Product labels, instructions for use (IFU) in Bahasa Indonesia.
• Risk management documentation: ISO 14971-compliant risk analysis.

3. Submit Application to BPOM

Where to Apply:

• You must submit your application to Badan Pengawas Obat dan Makanan (BPOM), the Indonesian Food and Drug Authority, which oversees medical device regulation in Indonesia.

Online Submission (Preferred) via e-Registry:

• BPOM’s e-Registry system is the most common and efficient way to submit the registration application for medical devices.
  • Website: Visit the BPOM official website and register on the e-Registry system.
  • Submission Process: Upload the complete registration dossier, including the application form, device description, clinical data, certificates, labeling, and other required documents.
  • After submission, BPOM will process the application and may request additional information or clarification.

Physical Submission (If Necessary):

• If the e-Registry system is unavailable or you prefer paper submission, you can submit your application in person to BPOM’s office in Jakarta.

  BPOM Office Address:

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

• In this case, the registration dossier must be submitted along with all required documentation.

4. BPOM Evaluation

• BPOM will review your application and documentation to ensure that the medical device complies with Indonesian regulations. The review will typically involve:
  • Clinical and safety data review.
  • Verification of quality management system (ISO 13485, GMP).
  • Evaluation of product performance and compliance with standards (e.g., IEC 60601 for electrical devices).
• If BPOM requests additional documentation or information, you will need to submit it promptly.

5. BPOM Decision and Issuance of Registration Certificate

• After the evaluation, BPOM will either approve the application or request further documentation.
• Once the application is approved, BPOM will issue a registration certificate, allowing you to legally market the Class 3 medical device in Indonesia.
  • The registration is typically valid for 5 years, after which you will need to renew the registration.

6. Post-Market Surveillance

• After registration, the manufacturer is responsible for ongoing post-market surveillance, including:
  • Reporting adverse events or safety issues.
  • Conducting product recalls if necessary.
  • Submitting any new clinical data or changes to the device.

Conclusion:

To apply for Class 3 medical device registration in Indonesia:

1. Appoint an authorized representative (for foreign manufacturers).
2. Prepare the required documentation, including clinical data, certificates, performance reports, and labeling.
3. Submit the application via BPOM’s e-Registry system (or physically at BPOM’s office if needed).
4. BPOM will evaluate your application and issue a registration certificate upon approval.
5. Comply with post-market surveillance and renewal requirements after the registration period.

Where to Apply:

• BPOM e-Registry system (online submission).
• BPOM Office: Jl. Percetakan Negara No. 23, Jakarta, Indonesia (for paper submissions).

If you need help with specific steps or documents, feel free to ask!

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn