To apply for Class 3 medical device registration with the Indonesian Ministry of Health (MOH) and Badan Pengawas Obat dan Makanan (BPOM), you need to follow a structured and comprehensive process to ensure that your device meets regulatory requirements and is safe for use in Indonesia. Below is a detailed step-by-step guide on how to apply for Class 3 medical device MOH registration in Indonesia:

Step-by-Step Process for Applying for Class 3 Medical Device MOH Registration in Indonesia

Step 1: Determine Device Classification

• Class 3 Devices are high-risk medical devices that require extensive documentation and clinical data to demonstrate their safety and effectiveness.
• Device Classification: Ensure that your device is classified as Class 3 according to Indonesian regulations. BPOM uses a risk-based classification system to categorize medical devices (Class 1, 2, or 3). Class 3 devices are typically high-risk and require thorough evaluation.

If unsure about the classification, you may consult BPOM or a regulatory expert to verify the classification of your device.

Step 2: Appoint a Local Authorized Representative

• Local Representative: If you are a foreign manufacturer, you must appoint a local authorized representative (such as a local distributor, importer, or regulatory consultant) in Indonesia to act as your official point of contact with BPOM.
• This representative will be responsible for submitting the application on your behalf and managing communications with BPOM.

Step 3: Prepare the Required Documentation

You need to prepare a comprehensive set of documents to support your application for Class 3 medical device registration. These documents include:

1. Application Form: Complete the registration application form available on the BPOM portal or from your authorized representative.

2. Device Description and Information:

   • Device name and model.
   • Manufacturer's details (name, address, and contact information).
   • Intended use and indications of the device.
   • Risk assessment and risk management plan based on ISO 14971.

3. Clinical Data:

   • Clinical trial results or scientific literature to demonstrate the safety and efficacy of the device. BPOM may request clinical data, especially for Class 3 devices.
   • If clinical trials were conducted, include trial protocols, reports, and results.
   • BPOM may accept international clinical trial data if it meets the Indonesian regulatory standards.

4. Manufacturing Documentation:

   • ISO 13485 certificate or equivalent, proving that the manufacturer complies with Good Manufacturing Practices (GMP).
   • Manufacturing process documentation, including any subcontractors involved.
   • Quality Management System (QMS) certificates.

5. Testing and Compliance Reports:

   • Performance testing results demonstrating that the device meets international standards (e.g., IEC 60601 for electrical devices, ISO 10993 for biocompatibility).
   • Stability studies, if applicable.

6. Labeling and Packaging:

   • Device labeling in Bahasa Indonesia, which includes the device’s name, model, manufacturer information, intended use, and safety warnings.
   • Packaging details in accordance with Indonesian regulations.

7. Authorization Documents:

   • If applicable, submit a local importer or distributor license to BPOM.
   • A letter of authorization from the manufacturer designating the local representative to act on their behalf.

Step 4: Submit the Application to BPOM

• Online Submission: After gathering all necessary documentation, submit the application through BPOM's e-registration system or directly to BPOM via the relevant registration portal.
• BPOM may also request hard copies of some documents, especially if clinical trials or manufacturing facility inspections are involved.

If you are using a local authorized representative, they will typically manage the submission and ensure that all documents are in order.

Step 5: BPOM Evaluation and Review

Once your application is submitted, BPOM will begin its evaluation process. The review process typically involves the following steps:

1. Document Review: BPOM will assess all the technical documents, clinical data, and manufacturing information to ensure the device complies with Indonesian standards and regulations.

2. Risk Assessment: BPOM will assess the risk profile of your device based on its intended use and any supporting clinical or performance data.

3. Device Inspection (if necessary): If required, BPOM may conduct a Good Manufacturing Practice (GMP) inspection at the manufacturing site to verify compliance with Indonesian regulatory standards. This is more common for foreign manufacturers.

4. Consultation with Experts: For complex or high-risk devices, BPOM may consult with external experts or advisory committees to ensure the device’s safety and effectiveness.

5. Evaluation of Labeling: BPOM will check whether the labeling and packaging comply with Indonesian regulatory requirements, including language and safety information.

Step 6: Pay Registration Fees

• BPOM will issue an invoice for the registration fee once the initial review of the application is completed.

• Fees depend on the type and classification of the device. For Class 3 devices, the fees are typically higher than those for Class 1 or Class 2 devices.

• Payment: The registration fee must be paid promptly to avoid delays. Once paid, BPOM will proceed with the next steps in the process.

Step 7: BPOM Approval and Registration Certificate

After reviewing your application and verifying the device’s compliance with all regulatory requirements, BPOM will issue the registration certificate for your device.

• The registration certificate will include the registration number, which is required for marketing the device in Indonesia.
• You must include the registration number on your product’s labeling and packaging.

Step 8: Post-Registration Requirements

Once your device is registered, you must comply with ongoing regulatory obligations:

1. Post-Market Surveillance: Monitor the device’s performance once it is in the market, including reporting any adverse events or device malfunctions.

2. Annual Maintenance Fee: Some devices require an annual maintenance fee for continued registration.

3. Renewal: Class 3 device registrations are typically valid for 5 years. After this period, you will need to re-register your device with BPOM.

4. Adverse Event Reporting: You must report any serious adverse events or safety concerns to BPOM as per their guidelines.

Key Considerations

• Local Representative: If you are a foreign manufacturer, you must appoint a local representative (importer or distributor) to handle all interactions with BPOM and ensure compliance with Indonesian regulations.

• Timeframe: The registration process for Class 3 devices typically takes 6 to 12 months, depending on factors such as the complexity of the device, the completeness of the documentation, and BPOM’s workload.

• Compliance with Standards: Ensure that the device complies with international standards (e.g., ISO 13485, ISO 14971) and that clinical data is in line with Indonesian requirements.

Conclusion

The process of applying for Class 3 medical device registration in Indonesia requires thorough preparation, especially when it comes to documentation and compliance with local regulations. It is highly recommended to work with a local authorized representative to help navigate the process efficiently. Additionally, ensuring that your documentation is complete and accurate will help avoid delays during the review process.

If you have specific questions about any stage of the process or need more detailed guidance, feel free to ask!

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