Process and Steps for B-Class Medical Device Registration in Indonesia (MOH/BPOM)

Registering a B-class medical device in Indonesia through the Ministry of Health (MOH) and the Indonesian Food and Drug Authority (BPOM) involves several key steps. B-class devices are considered to have moderate risk to patient health and require a more detailed registration process than lower-risk A-class devices but are less rigorous than higher-risk C- and D-class devices.

Here’s the step-by-step process for B-class medical device registration in Indonesia:

Step 1: Classify the Device

• Identify Device Classification: Confirm that your device qualifies as a B-class medical device. B-class devices are categorized as moderate risk medical devices.
  • This classification depends on the intended use, risk to the patient, and degree of invasiveness.
  • B-class devices may include surgical instruments, diagnostic devices, dental devices, etc.
• Regulatory Reference: BPOM uses the Indonesian Medical Device Regulatory Guidelines to classify devices. Ensure that your device matches the description of B-class devices.

Step 2: Appoint a Local Authorized Representative (if applicable)

• If your company is based outside of Indonesia, you must appoint a local authorized representative in Indonesia to submit the registration on your behalf.
• The representative must be registered with BPOM and will act as the liaison between your company and BPOM.

Step 3: Prepare the Required Documents

Gather and prepare the necessary documents for submission. The key documents for a B-class medical device registration typically include:

1. Product Information

   • Name and description of the device.
   • Intended use and indications for use.
   • Materials, design, and components.

2. Manufacturing License / Certificate

   • Proof that the device is manufactured in a licensed facility (domestic or international).

3. Free Sale Certificate

   • A certificate issued by the regulatory authority of the country of origin, confirming that the device is legally marketed there.

4. Clinical Evaluation / Performance Data (if applicable)

   • For certain devices, clinical evidence demonstrating safety and efficacy may be required.

5. Risk Management Documentation

   • A risk assessment or management document showing that the device complies with safety standards.

6. Product Labeling

   • Labels, instructions for use, and packaging materials in Indonesian (Bahasa Indonesia), as required by the regulations.

7. ISO Certifications (if applicable)

   • Proof of compliance with international quality standards (e.g., ISO 13485, ISO 14971).

8. Certificate of Conformity (if applicable)

   • Certification that the device complies with international or Indonesian standards.

Step 4: Submit Application through BPOM’s e-Registration System

• Create an Account: Register on BPOM’s e-registration portal (e-licensing system).
• Complete the Application Form: Fill out the required application forms for B-class medical devices.
• Submit Documents: Upload all necessary documents, including product information, certificates, labeling, and risk assessments.
• Pay Application Fees: Pay the relevant application fees for registration (fees vary depending on the device and the complexity of the application).

Step 5: BPOM Review and Evaluation

• BPOM will review the submitted application to ensure that:
  • The device is correctly classified as a B-class medical device.
  • The submitted documentation is complete and accurate.
  • The device complies with Indonesian medical device regulations.
• BPOM will assess the safety, performance, and quality of the device based on the provided information and, if needed, conduct a risk analysis.

Step 6: Device Testing and Inspection (if required)

• BPOM may request additional testing or inspection depending on the device type. Common requirements include:
  • Performance Testing: Clinical or pre-clinical performance data to verify the safety and effectiveness of the device.
  • Local Testing: Some devices may require testing at an accredited laboratory in Indonesia.
  • Inspection: BPOM may perform an inspection of the manufacturing facility or request additional evidence of compliance with applicable standards.

Step 7: BPOM Approval and Issuance of Registration Certificate

• Approval: Once BPOM is satisfied with the review and testing (if applicable), they will approve the application.
• Registration Certificate: BPOM will issue a Surat Izin Edar (SIE), or Registration Certificate, which allows you to market and sell the device in Indonesia.
  • The registration certificate will include the device's registration number and validity period.

Step 8: Post-Market Surveillance and Reporting

• After receiving the registration certificate, manufacturers must comply with post-market surveillance (PMS) requirements, which include:
  • Adverse Event Reporting: Reporting any adverse events or incidents related to the device to BPOM.
  • Periodic Updates: Submitting updated safety or performance data as required by BPOM.
  • Device Recalls: If there are safety issues with the device, you must comply with any recall procedures initiated by BPOM.

Key Considerations:

• Language Requirement: All documents, including labels and instructions for use, must be in Bahasa Indonesia.
• Local Representative: If you are not based in Indonesia, appointing a local authorized representative is essential.
• Regulatory Compliance: Ensure that your device complies with local Indonesian regulatory standards and international guidelines (e.g., ISO 13485, ISO 14971).
• Risk Management: Proper risk management practices and documentation are critical for successful registration.

By following these steps, you can successfully register a B-class medical device in Indonesia and ensure it is compliant with the regulations set forth by BPOM.

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