For Class I medical device registration with the Indonesia Ministry of Health (MOH) through BPOM, the technical document requirements are generally less stringent compared to higher-risk medical devices (Class II and III), but they still need to comply with specific regulatory standards. The required technical documents ensure that the device is safe, effective, and compliant with Indonesian laws.

Here are the key technical document requirements for Class I medical device registration with BPOM:

1. Device Description and Technical Specifications

• Description of the Device: A detailed explanation of the device’s function, intended use, and how it operates.

  • What is the device? (e.g., thermometer, bandage, wheelchair)
  • What is its intended purpose? (e.g., temperature measurement, wound care)
  • Any technical specifications (e.g., materials used, dimensions, operating principles).

• Product Features and Specifications: Include specific details about the product, such as:

  • Materials: What materials are used in the device (e.g., latex, plastic, metal).
  • Dimensions: Size and weight of the device.
  • Mechanical/Performance Features: Any specific features related to how the device works (e.g., temperature range for thermometers).
  • Electrical Safety (if applicable): If the device has electrical components, include documentation on safety standards (e.g., IEC 60601 for electrical safety).

• Risk Classification: Ensure the device is classified correctly as Class I based on its risk category and intended use.

2. Manufacturer Information

• Manufacturing Details: Provide details about the manufacturer’s name, address, and contact information.
  • A Good Manufacturing Practice (GMP) or ISO 13485 certification or equivalent is required to ensure that the device is manufactured following internationally recognized quality standards.
• Authorization for the Local Representative: A letter or document authorizing the local representative (in Indonesia) to submit the registration on behalf of the manufacturer.

3. Certificate of Free Sale (CFS)

• A Certificate of Free Sale (CFS) issued by the competent regulatory authority in the country of origin.
  • The CFS confirms that the medical device is legally sold in the country of origin and that it meets the applicable regulatory requirements for sale.
  • If the device is sold in other countries, the CFS should list these countries and confirm the device is in good standing.

4. Labeling and Packaging Information

• Labeling in Bahasa Indonesia: All medical devices must have labeling in the official language of Indonesia (Bahasa Indonesia). This includes:
  • Product Name and Intended Use.
  • Manufacturer's name and contact information.
  • Instructions for Use (IFU): Clear and concise instructions on how to use the device.
  • Warnings and Precautions: Any safety information, contraindications, or warnings.
  • Expiration Date (if applicable).
  • Storage Conditions (if applicable).
• Packaging: Detailed description of how the device is packaged and protected for shipment. Include any packaging labels and material specifications.
  • Ensure packaging materials comply with safety standards (e.g., anti-static for electronic devices, sterile packaging for medical devices that require sterility).

5. Safety and Performance Data

• Safety and Performance Documentation: While Class I devices are low-risk and typically don’t require clinical trial data, safety and performance test reports may still be required, especially for devices that are new or innovative.
  • Test Reports (if applicable):
    • For biocompatibility (if the device contacts the body).
    • Electrical Safety (for electrical devices).
    • Mechanical performance tests (e.g., tensile strength, durability).
    • Sterility testing (for sterile devices).
• These documents can either be internal test data or third-party testing results that demonstrate the device's safety and effectiveness.

6. Declaration of Conformity

• A Declaration of Conformity from the manufacturer confirming that the medical device complies with the relevant Indonesian regulations and international standards.
  • This document typically includes a statement that the device complies with GMP or ISO 13485 (if applicable) and confirms the device’s safety and effectiveness.

7. Post-Market Surveillance Plan

• A post-market surveillance plan outlining how the manufacturer or local representative will monitor the device after it is placed on the market.
  • This includes processes for managing adverse events, reporting defects or recalls, and ensuring that the device continues to meet safety standards once it is in use.
• Adverse Event Reporting: A process to ensure that any safety issues or adverse events related to the device are reported to BPOM and the manufacturer takes corrective actions when needed.

8. Importer and Distribution Details (for Imported Devices)

• Importer License: If the device is being imported into Indonesia, the importer must have a valid import license from BPOM. The local representative (AR) is usually responsible for this.
• Distributor Information: Details about the distributor in Indonesia, if applicable.

9. Additional Documents for Specific Device Types (if applicable)

• Sterility Certification: For devices that are sterile, such as surgical instruments, provide sterilization validation documentation (e.g., validated sterilization processes, batch certificates).
• Animal Testing Reports: If the device uses materials of animal origin or is involved in procedures that require animal testing, provide relevant documentation on animal testing or certification that no animal-derived materials are used.

Summary of Key Technical Document Requirements for Class I Medical Device Registration:

1. Device Description and Technical Specifications: Details of device function, specifications, materials, and any safety standards (e.g., electrical safety).
2. Manufacturer Information: Manufacturer’s contact information and GMP or ISO certifications.
3. Certificate of Free Sale (CFS): Confirming the device is legally sold in its country of origin.
4. Labeling and Packaging Information: Labels and instructions for use in Bahasa Indonesia.
5. Safety and Performance Data: Test reports for biocompatibility, electrical safety, sterility, or other relevant safety/performance data.
6. Declaration of Conformity: Statement that the device complies with relevant regulations.
7. Post-Market Surveillance Plan: Ensuring device safety after being sold.
8. Importer License: Required for imported devices.

Conclusion

The technical documents required for Class I medical device registration with BPOM are mainly aimed at ensuring the device’s safety, effectiveness, and compliance with Indonesian regulations. The local authorized representative (AR) will be responsible for preparing and submitting these documents on behalf of the foreign manufacturer.

If you need any help with specific documents or further clarification, feel free to ask!