For Class 3 medical device registration with the Indonesian Ministry of Health (MOH) through Badan Pengawas Obat dan Makanan (BPOM), the technical document requirements are crucial for demonstrating the device’s safety, efficacy, and compliance with local regulations. Since Class 3 devices are considered high-risk devices, they undergo a rigorous review process that requires comprehensive technical documentation. Below is an outline of the key technical documents required for Class 3 medical device registration in Indonesia:

1. Device Description and Labeling

• Device Name and Description: A detailed description of the device, including its intended use, indications, model, and any important characteristics.
• Labeling: The product labeling must comply with Indonesian regulations and should include:
  • Device name and model.
  • Manufacturer information.
  • Intended use and any contraindications.
  • Instructions for use (IFU) in Bahasa Indonesia.
  • Warnings, precautions, and storage conditions.
  • Expiration date (if applicable).
  • Device classification and regulatory status.

2. Quality Management System (QMS) and Manufacturing Information

• ISO 13485 Certificate: A certificate that shows the manufacturer’s compliance with the Quality Management System for medical devices (ISO 13485). This demonstrates that the device is manufactured in a controlled environment with proper quality checks.
• Good Manufacturing Practice (GMP) Certificate: Proof that the manufacturer adheres to GMP standards for medical devices. BPOM may require a GMP inspection of the manufacturing facility.
• Manufacturing Facility Information: Details about the manufacturing site, including its compliance with GMP and any FDA, CE, or other international certifications.

3. Clinical Evaluation and Safety Data

• Clinical Trial Data: For Class 3 devices, clinical trial data is required to prove the device’s safety and effectiveness. This could include:

  • Results from pre-market clinical trials or post-market surveillance from other markets.
  • The data must demonstrate that the device performs as intended without causing harm to patients.
  • Clinical trials should be conducted in compliance with Good Clinical Practice (GCP).

• Post-market Data: If the device has been marketed in other countries, post-market surveillance data (e.g., adverse event reports) can supplement clinical data.

• Risk Management Documentation: A risk analysis in accordance with ISO 14971, outlining the potential risks associated with the device and how these risks are mitigated. This includes:

  • Risk analysis for the device (safety, biocompatibility, etc.).
  • Risk control measures implemented during the development and manufacturing process.
  • Post-market risk monitoring plan.

4. Performance Test Reports

• Electrical Safety Testing: If the device is electrical (e.g., diagnostic equipment, therapeutic devices), provide IEC 60601 test reports for electrical safety and electromagnetic compatibility (EMC).

  • The device must pass performance tests related to electrical safety (e.g., insulation, grounding) and electromagnetic emissions (e.g., interference with other devices).

• Biocompatibility Testing: For devices in direct contact with the body, ISO 10993 or equivalent biocompatibility testing is required. This includes:

  • Cytotoxicity, sensitization, irritation, and systemic toxicity tests.
  • Documentation of the test results, performed by accredited laboratories.

• Sterility Testing: If the device is sterilized (e.g., surgical instruments), you must provide sterility validation reports and testing data.

• Packaging and Shelf-life Testing: If applicable, you must demonstrate that the device’s packaging ensures its sterility or integrity during storage and transportation, including shelf-life stability data.

5. Product Testing and Specifications

• Product Specifications: Detailed technical specifications of the medical device, including:
  • Materials used in the device.
  • Technical performance specifications (e.g., operating conditions, accuracy, and precision for diagnostic devices).
  • Dimensions, weight, and other relevant physical characteristics.
• Test Reports: If applicable, any third-party performance testing or evaluation reports to show the device meets relevant performance standards.

6. Certificate of Free Sale (CFS)

• For foreign manufacturers, a Certificate of Free Sale (CFS) from the country of origin is required, indicating that the device is legally sold and marketed in that country.
  • The CFS should be issued by the national health authority (e.g., FDA in the USA, CE mark in the EU).

7. Risk Management File (ISO 14971)

• Risk management documentation compliant with ISO 14971 is essential for Class 3 devices. This should include:
  • Risk analysis: Identification of potential risks to patients, users, and the environment.
  • Risk evaluation: The severity of potential risks and their likelihood.
  • Risk control measures: Actions taken to mitigate identified risks.

8. Post-market Surveillance Plan

• A post-market surveillance plan that outlines how the manufacturer will monitor the device’s safety and performance once it is on the market.
  • This includes procedures for reporting adverse events, conducting field safety corrective actions (FSCA), and maintaining records of complaints.

9. Additional Documentation (if applicable)

• Clinical Evaluation Report (CER): If the device is a high-risk implant or has a novel technology, a Clinical Evaluation Report (CER) may be required, summarizing the clinical data and evaluation of the device's safety and effectiveness.

• Traceability Documentation: In some cases, you may need to provide traceability information, especially for devices that are part of a family or have modular components.

Summary of Required Technical Documents for Class 3 Medical Device Registration in Indonesia:

1. Device description and labeling (including Bahasa Indonesia translation).
2. ISO 13485 certificate and GMP certification.
3. Clinical data (including clinical trials, post-market surveillance).
4. Risk management file (ISO 14971).
5. Performance test reports (electrical safety, biocompatibility, sterility testing, etc.).
6. Product specifications and test reports.
7. Certificate of Free Sale (CFS) for foreign manufacturers.
8. Post-market surveillance plan.
9. Additional reports as necessary (e.g., Clinical Evaluation Report, traceability documents).

Conclusion:

The technical document requirements for Class 3 medical device registration in Indonesia are comprehensive and involve a combination of clinical, performance, and risk management data. It is essential to submit well-organized, complete, and accurate documentation to avoid delays in the registration process. BPOM will review the documents to ensure that the device is safe, effective, and meets local regulatory standards.

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