The process for registering a Class 3 medical device with the Indonesian Ministry of Health (MOH) and Badan Pengawas Obat dan Makanan (BPOM) involves a series of steps that ensure compliance with Indonesian regulations, including submission of technical documentation, risk assessments, and clinical data. Class 3 medical devices are considered high-risk, so the registration process is more detailed and thorough compared to lower-risk devices. Below is a breakdown of the step-by-step process for Class 3 medical device registration in Indonesia:

1. Pre-Registration Preparation

Before beginning the registration process, it is essential to ensure that all the necessary prerequisites are in place:

1.1 Appoint a Local Authorized Representative

• Foreign manufacturers must appoint a local authorized representative in Indonesia, such as a local distributor, importer, or regulatory consultant. This representative will handle all interactions with BPOM, submit the registration application, and manage post-market obligations.

1.2 Device Classification Verification

• Confirm that your device is classified as Class 3 under Indonesian regulations. This classification applies to high-risk medical devices, such as implantable devices, life-supporting devices, and devices that require a high level of clinical validation.
• If you are unsure about the classification, consult BPOM or a regulatory expert to determine the appropriate classification.

1.3 Device Compliance with International Standards

• Ensure the device complies with relevant international standards, such as ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), and IEC 60601 (electrical safety for medical devices).

2. Prepare the Required Documentation

For Class 3 medical devices, the documentation requirements are extensive and must be prepared carefully. Below is a list of the key documents that must be submitted:

2.1 Application Form

• Complete the official registration application form provided by BPOM. This form will ask for general details about the device, manufacturer, and local representative.

2.2 Device Information

• Detailed description of the device, including:
  • Device name, model, and brand.
  • Intended use, clinical indications, and target patient population.
  • Device classification and rationale.

2.3 Clinical Data

• Since Class 3 devices are high-risk, BPOM typically requires clinical evidence to support the device's safety and efficacy. This may include:
  • Clinical trial data, if applicable, to demonstrate safety and effectiveness.
  • Clinical performance data, including studies or post-market surveillance reports.
  • If the device is already approved in other countries (e.g., CE Mark, FDA approval), BPOM may accept clinical data from these markets.

2.4 Risk Management Documentation

• Submit a risk management report in compliance with ISO 14971 that evaluates potential risks associated with the device and describes how these risks are mitigated.

2.5 Manufacturing Information

• Provide evidence that the manufacturing facility complies with Good Manufacturing Practices (GMP), such as:
  • ISO 13485 certification.
  • Manufacturing process details.
  • Quality control procedures and testing methods.
  • If the device is manufactured outside Indonesia, BPOM may request a GMP inspection of the foreign manufacturing facility.

2.6 Product Testing and Compliance

• Submit any relevant performance testing, including electrical, mechanical, and biological testing.
• Provide evidence of compliance with applicable standards such as IEC 60601 for electrical safety and ISO 10993 for biocompatibility.

2.7 Labeling and Packaging

• Submit the product labeling in Bahasa Indonesia, including:
  • Device name, manufacturer details, intended use, and safety information.
  • Instructions for use and any applicable warnings.
  • Packaging information, ensuring it complies with BPOM's labeling standards.

2.8 Authorized Representative Letter

• Include a letter of authorization from the manufacturer that designates the local representative to act on their behalf in Indonesia.

3. Submit the Application to BPOM

• Once all the required documentation is prepared, the local authorized representative can submit the application through BPOM’s e-registration system or directly to BPOM.
• BPOM may require both electronic and hard copies of the documentation, depending on the type of device and the complexity of the application.

4. BPOM Evaluation and Review

BPOM will carefully evaluate the submitted application and all related documentation. The evaluation process for Class 3 devices typically includes:

4.1 Document Review

• BPOM reviews the clinical data, testing results, risk management, and manufacturing compliance.
• Labeling and packaging will be reviewed to ensure compliance with Indonesian regulations.

4.2 Inspection (if required)

• BPOM may conduct an on-site GMP inspection of the manufacturing facility if the device is produced overseas. This is typically required for higher-risk devices like Class 3 medical devices.

4.3 Expert Consultation

• For particularly complex or high-risk devices, BPOM may consult with external experts or an advisory committee to ensure the device’s safety and efficacy.

4.4 Evaluation Timeline

• The evaluation process for Class 3 devices can take 3 to 6 months or longer, depending on the complexity of the device, completeness of the submitted data, and whether BPOM requires additional information or inspection.

5. Pay Registration Fees

• BPOM will issue an invoice for the registration fee after completing the initial evaluation. The fees depend on the type of device and its classification.
• The payment of the registration fee must be made promptly to continue the process. The payment receipt will need to be submitted to BPOM.

6. BPOM Approval and Registration Certificate

• After successful evaluation and payment of the registration fee, BPOM will issue the registration certificate.
• The certificate will include the registration number, which is required for marketing the device in Indonesia.
• This registration typically lasts for 5 years, after which the device will need to be re-registered.

7. Post-Registration Obligations

Once your device is registered with BPOM, several post-registration requirements must be met:

7.1 Post-Market Surveillance

• You must monitor the device’s performance in the market and report any adverse events or malfunctions to BPOM.

7.2 Annual Maintenance Fee

• Some devices require an annual maintenance fee to maintain registration status.

7.3 Re-Registration

• Class 3 medical devices must be re-registered every 5 years. The re-registration process involves submitting updated documentation and paying the necessary fees.

7.4 Adverse Event Reporting

• Manufacturers must report any serious adverse events or device malfunctions to BPOM, as per Indonesian regulations.

Typical Timeline for Class 3 Medical Device Registration

• Pre-Registration Preparation: 1-2 months to gather documentation.
• BPOM Evaluation and Review: 3-6 months (or longer depending on device complexity).
• Payment of Fees: 1-2 weeks.
• Approval and Issuance of Registration Certificate: 1-2 months.
• Total Time: The full process generally takes 6 to 12 months from submission to approval.

Key Considerations

• Local Representation: It is mandatory for foreign manufacturers to have a local authorized representative in Indonesia to submit the application and manage communication with BPOM.
• Clinical Data: BPOM requires substantial clinical data for Class 3 devices. Ensure that you have sufficient clinical trial results or scientific literature to demonstrate the safety and effectiveness of the device.
• Compliance with Standards: Ensure your device complies with international standards (e.g., ISO 13485, ISO 14971) and BPOM’s specific requirements.
• Post-Market Surveillance: After registration, maintain a robust post-market surveillance system to monitor device performance and address any adverse events.

Conclusion

Registering a Class 3 medical device with BPOM in Indonesia is a rigorous process that requires careful preparation of documentation, clinical data, and compliance with local regulations. Working with a local authorized representative and ensuring that all the required information is submitted in a timely manner will help ensure a smooth registration process. Be prepared for a review process that can take several months and be ready to address any additional requests from BPOM.

If you have any specific questions or need further assistance with the process, feel free to ask!

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