To apply for Class 3 medical device registration with the Indonesian Ministry of Health (MOH), through Badan Pengawas Obat dan Makanan (BPOM), there are specific steps, required documents, and key considerations. Below is a detailed guide:

Steps for Class 3 Medical Device Registration in Indonesia:

Step 1: Appoint an Authorized Representative (for Foreign Manufacturers)

• Foreign manufacturers are required to appoint a local authorized representative in Indonesia. This representative will be the main point of contact with BPOM and will submit the registration application.
• Local manufacturers may apply directly without the need for an authorized representative.

Step 2: Ensure Compliance with Indonesian Regulations

• The medical device must meet Indonesian regulations, which are in line with international standards (e.g., ISO 13485, ISO 14971, IEC 60601, etc.).
• Confirm that the device complies with the Indonesian medical device regulations and classification standards for Class 3 devices (high-risk devices).

Step 3: Prepare the Registration Dossier

Prepare a complete registration dossier that includes all necessary documentation as required by BPOM.

Required Documents for Class 3 Medical Device Registration

1. Application Form

   • Complete BPOM's registration application form, available through the BPOM e-Registry system or physical submission if necessary.

2. Device Description

   • A detailed description of the device, including:
     • Intended use and indications.
     • Mechanism of action.
     • Key components and materials.
     • Product specifications (e.g., performance characteristics, size, etc.).

3. Manufacturing and Quality Information

   • Manufacturing Process: Detailed information about the device’s manufacturing process, design, and controls.
   • ISO 13485 Certificate: Evidence that the manufacturer follows a Quality Management System (QMS) compliant with international standards for medical devices.
   • Good Manufacturing Practice (GMP): Confirmation that the manufacturing facility complies with GMP standards.

4. Clinical Data

   • Clinical evidence showing that the device is safe and effective, particularly for Class 3 devices. This may include:
     • Clinical trial data or studies.
     • Post-market surveillance data (for devices already marketed in other countries).
     • Published scientific literature or white papers that support the device’s safety and efficacy.

5. Risk Management Documentation

   • A risk management file per ISO 14971, identifying the potential hazards and risks, along with measures to mitigate them.
   • Biocompatibility testing (for devices that have direct contact with patients).
   • Any hazard analysis and failure mode assessments.

6. Certificates and Approvals

   • Certificate of Free Sale (CFS): Issued by the country of origin or competent health authority, confirming that the device is legally marketed in the country of manufacture.
   • Declaration of Conformity: A statement confirming that the device complies with all relevant standards and regulations (such as CE marking or FDA approval).
   • ISO 13485 certificate.
   • Test reports for performance or safety testing (e.g., electrical safety for electrical medical devices, compliance with IEC 60601).

7. Labeling and Instructions for Use

   • Product labeling in Bahasa Indonesia (Indonesian language), which must include:
     • Device name, model, and serial number.
     • Intended use and indications.
     • Manufacturer’s details, and the authorized representative (if applicable).
     • Warnings, precautions, contraindications, and instructions for use.
     • Expiry date, if applicable.
   • Packaging Information: Instructions for packaging, storage, and handling.

8. Manufacturing Site Information

   • If applicable, provide documentation showing compliance with GMP at the manufacturing facility.
   • BPOM may request an on-site inspection to verify GMP compliance.

Step 4: Submit the Registration Application to BPOM

• Submit the completed registration dossier to BPOM. This can be done through BPOM’s e-Registry system (for electronic submission) or directly to BPOM’s office in Jakarta (for physical submission).
• The registration application should include all the documents listed above, along with the application form.

Step 5: BPOM Evaluation and Review

• BPOM will review the application to verify that all necessary documents are complete and meet the required regulatory standards.
  • The evaluation process typically involves:
    • Reviewing clinical data, risk management reports, and manufacturing documentation.
    • Assessing the device’s safety, performance, and compliance with Indonesian regulations.
    • BPOM may request additional information or clarification during the review process.
    • BPOM may also request on-site inspections of manufacturing facilities.

Step 6: Issuance of Registration Certificate

• After BPOM’s successful evaluation, they will issue a registration certificate that allows the device to be marketed in Indonesia.
  • The certificate will typically be valid for 5 years, after which the manufacturer will need to apply for renewal.

Step 7: Post-Market Surveillance

• Once the device is on the market, the manufacturer is responsible for monitoring its performance in the market and reporting any adverse events or defects.
• Post-market surveillance requirements include:
  • Reporting any incidents or problems associated with the device.
  • Providing updates to BPOM about any new clinical data or changes in manufacturing.
  • Conducting product recalls if necessary.

Important Notes and Considerations

1. Clinical Data: For Class 3 devices, clinical evidence is essential. BPOM will carefully review clinical trial data and scientific studies demonstrating the device’s safety and efficacy. Devices that are novel or have new technologies will require robust clinical trial data.

2. Labeling in Bahasa Indonesia: Product labeling and instructions for use must be provided in Bahasa Indonesia. If submitting in English, an official translation to Indonesian is required.

3. ISO Certification: It is highly recommended to have ISO 13485 certification (Quality Management System for medical devices) to demonstrate compliance with global standards. This will also be necessary for foreign manufacturers to show their quality system is robust.

4. Post-Market Requirements: After registration, manufacturers must adhere to Indonesia’s post-market surveillance requirements, including reporting any adverse events, conducting recalls if necessary, and complying with BPOM’s periodic reporting requirements.

5. On-Site Inspection: BPOM may conduct on-site inspections of the manufacturing facilities to verify that the manufacturer complies with GMP (Good Manufacturing Practices).

6. Application Timeline: The evaluation process by BPOM can take several months (typically 6-12 months or longer, depending on the complexity of the device and completeness of the submission).

7. Renewal: After 5 years, the registration must be renewed, and the manufacturer will need to submit updated documentation and pay the applicable fees for renewal.

Conclusion:

To apply for Class 3 medical device registration in Indonesia, the key steps include appointing an authorized representative (if foreign), ensuring regulatory compliance, preparing a comprehensive registration dossier, submitting the application to BPOM, and undergoing BPOM’s evaluation process. Once approved, manufacturers must comply with post-market surveillance requirements and periodically renew their registration.

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