In Indonesia, Class 3 medical devices are those that are considered to carry a high risk to the patient or user. These devices are typically life-sustaining or life-supporting, implantable, or those that may have a significant risk of causing harm if they fail to perform as intended. Examples include pacemakers, heart valves, and neurostimulators.

The Indonesian Ministry of Health (MOH) oversees the registration and regulation of medical devices through the Badan Pengawas Obat dan Makanan (BPOM), which is the Indonesian Food and Drug Authority. To market and distribute Class 3 medical devices in Indonesia, manufacturers must complete a registration process with BPOM. Below is an outline of how to apply for Class 3 medical device registration with the Indonesian MOH.

Steps to Apply for Class 3 Medical Device Registration in Indonesia:

1. Appoint an Authorized Representative

• Foreign manufacturers must appoint a local authorized representative in Indonesia to handle the registration process with BPOM. This representative will serve as a point of contact for all communications and submissions.
• Indonesian companies can apply directly if they are the manufacturer.

2. Ensure Compliance with Indonesian Regulations

• The device must comply with Indonesian medical device regulations, which are generally in line with international standards, including:
  • ISO 13485 for Quality Management Systems (QMS).
  • ISO 14971 for Risk Management.
  • IEC 60601-1 for medical electrical equipment (if applicable).

3. Prepare the Registration Dossier

The application dossier should include detailed information about the medical device and its compliance with regulatory requirements. Key documents for a Class 3 medical device registration include:

• Product Information:
  • Description of the device.
  • Intended use and indications.
  • Design and manufacturing process.
  • List of components and materials.
• Clinical Data:
  • Clinical trials or scientific evidence showing safety and effectiveness.
  • Post-market surveillance data (if applicable).
• Risk Management Documentation:
  • A risk analysis based on ISO 14971.
• Certificates and Approvals:
  • Certificate of Free Sale (CFS) issued by the competent health authority in the country of manufacture.
  • ISO 13485 certificate (if applicable).
  • Declaration of Conformity to state that the device complies with international standards (e.g., CE marking or FDA approval).
• Product Labeling and Instructions for Use:
  • In Indonesian, this should include clear instructions, safety warnings, and proper labeling as required by BPOM regulations.
• Packaging and Storage Information:
  • Including information on shelf life, conditions for storage, and transportation.

4. Submit the Application to BPOM

• Once all documents are ready, submit the complete registration dossier to BPOM. BPOM may request additional information or clarification during the evaluation process.
• The submission can be done either through BPOM's e-registry system (if available) or directly through BPOM offices.

5. Evaluation by BPOM

• BPOM will evaluate the registration application, including reviewing the technical and clinical data, assessing the risk profile of the device, and ensuring compliance with Indonesian standards.
• For Class 3 devices, BPOM may require additional clinical data or performance tests before approval is granted.
• BPOM may also conduct on-site inspections of manufacturing facilities or request product samples for testing.

6. Issuance of Registration Certificate

• If BPOM is satisfied with the submission, they will issue a registration certificate for the Class 3 medical device. This certificate grants the legal right to market and distribute the device in Indonesia.

7. Post-Market Surveillance

• Once the device is on the market, the manufacturer must comply with Indonesia's post-market surveillance requirements.
• This includes monitoring the device's performance, reporting adverse events, conducting recalls if necessary, and maintaining ongoing compliance with BPOM regulations.
• The manufacturer must also provide periodic reports or updates to BPOM, as required.

Key Requirements and Considerations for Class 3 Device Registration:

• Clinical Evidence: Class 3 medical devices require robust clinical data to demonstrate safety and efficacy due to their high-risk nature.
• Risk Management: BPOM requires a comprehensive risk management file to ensure patient safety.
• Documentation in Bahasa Indonesia: While documents can be submitted in English, the final product labeling and instructions for use must be in Bahasa Indonesia.
• Registration Validity: The registration is typically valid for 5 years, after which the device must undergo re-registration.

Timeline:

• The entire registration process can take several months (often 6–12 months) depending on the complexity of the device and the completeness of the submission.

Costs:

• Costs for registration may include application fees, testing fees, and the cost of appointing an authorized representative (if applicable).

Conclusion:

To register a Class 3 medical device in Indonesia, manufacturers need to submit a detailed registration dossier to BPOM, including clinical and technical data, risk management documentation, and other compliance evidence. Working with a local authorized representative can streamline the process. After BPOM's review and approval, the device will be granted a registration certificate for marketing in Indonesia.

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