Requirements for Technical Documents in Class A Medical Device Registration with Indonesia MOH

For Class A medical device registration with Indonesia’s Ministry of Health (MOH), you need to submit comprehensive technical documentation to demonstrate the safety, performance, and quality of the device. Although Class A devices are considered low-risk, the MOH still requires essential technical documents to ensure that the device complies with regulatory standards.

Below are the key technical document requirements for Class A medical device registration in Indonesia:

1. Device Description and Specifications

• Content: A detailed description of the medical device, including:
  • Device name and model.
  • Intended use: Clear description of the device’s purpose (e.g., diagnostic, therapeutic, preventive).
  • Product features and key specifications (e.g., dimensions, materials used, function).
  • Device classification (confirming that the device is Class A based on Indonesian regulation).
• Purpose: This document helps the MOH understand the basic nature and functionality of the device.

2. Risk Management Documentation

• Content: A risk management file that includes:
  • Risk analysis for the device, as per ISO 14971 (Risk management for medical devices).
  • Risk control measures: Steps taken to minimize identified risks (e.g., design changes, safety features).
  • Residual risks: A statement of any remaining risks after mitigation efforts.
• Purpose: To ensure that the device does not pose unacceptable risks to patient safety or user health. Even though Class A devices are low-risk, a thorough risk analysis is still necessary.

3. Performance and Safety Data

• Content: Documentation or test reports that demonstrate the device meets applicable safety and performance standards, which may include:
  • Biocompatibility (for devices that come into contact with patients or users).
  • Electrical safety (for electrical devices).
  • Sterility testing (if applicable for devices that require sterility).
  • Mechanical performance testing (for devices that involve mechanical functions).
  • Other relevant tests based on the device type (e.g., chemical stability, durability).
• Purpose: To demonstrate that the device is safe to use, effective for its intended purpose, and conforms to applicable technical standards.

4. Labeling

• Content: The label for the device must include:

  • Device name and model number.
  • Manufacturer’s name and address.
  • Local representative’s name and address (for non-Indonesian manufacturers).
  • Lot number/serial number for traceability.
  • Intended use and any warnings or precautions.
  • Expiration date (if applicable).
  • Storage conditions (e.g., temperature, humidity).
  • Instructions for use (IFU), including any Contraindications or Warnings.

• Translation: All labeling must be in Bahasa Indonesia, including the IFU.

• Purpose: To ensure that users can correctly identify the device, understand its use, and follow safety instructions.

5. Instructions for Use (IFU)

• Content: A user manual or Instructions for Use (IFU) that provides:

  • Step-by-step directions for using the device.
  • Warnings and contraindications (if applicable).
  • Maintenance and cleaning instructions.
  • Troubleshooting guidance (if applicable).

• Translation: The IFU must be translated into Bahasa Indonesia.

• Purpose: To ensure that users can safely and effectively use the medical device.

6. Declaration of Conformity (DoC)

• Content: A formal statement by the manufacturer (or authorized representative) declaring that the device conforms to applicable Indonesian regulations and standards, as well as any international standards (e.g., ISO 13485, ISO 14971).

• Purpose: To demonstrate the manufacturer's commitment to regulatory compliance and the device’s safety and quality.

7. Technical Drawings (if applicable)

• Content: For devices with complex designs or critical mechanical components, provide:
  • Design drawings and schematics.
  • Exploded views of the device assembly (if necessary).
• Purpose: To give the MOH a clearer understanding of the device’s construction and functioning, particularly for devices with intricate parts or innovative features.

8. Clinical Data (if applicable)

• Content: Clinical data may not always be necessary for Class A devices, but for certain low-risk devices, it may be required to demonstrate:
  • Clinical performance of the device (e.g., if it is used for diagnostic purposes).
  • Clinical safety (to show that the device does not harm patients).
• Purpose: To substantiate the device’s safety and effectiveness through clinical trials or real-world data (if applicable).

9. Compliance with Indonesian Standards

• Content: Documentation that proves compliance with any specific Indonesian national standards for medical devices (e.g., BPOM regulations, local safety standards).

• Purpose: To ensure that the device meets Indonesian-specific regulatory requirements and quality standards.

10. Packaging Information

• Content: Details or images of the packaging, including:
  • Primary packaging (e.g., individual device packaging).
  • Secondary packaging (e.g., shipping boxes).
• Purpose: To demonstrate that the packaging meets safety standards (e.g., integrity, protection against contamination) and includes appropriate labeling.

Summary of Technical Document Requirements:

1. Device Description and Specifications: Basic product details and intended use.
2. Risk Management Documentation: Risk analysis and control measures (per ISO 14971).
3. Performance and Safety Data: Test reports for safety, biocompatibility, electrical safety, etc.
4. Labeling: Includes device name, manufacturer, warnings, and instructions (translated into Bahasa Indonesia).
5. Instructions for Use (IFU): Detailed user manual, translated into Bahasa Indonesia.
6. Declaration of Conformity: Compliance statement with regulatory standards.
7. Technical Drawings (if applicable): Detailed design schematics.
8. Clinical Data (if applicable): Data supporting clinical safety and effectiveness.
9. Compliance with Indonesian Standards: Proof of adherence to local standards.
10. Packaging Information: Details of packaging materials and design.

Preparing Technical Documents

• Translate documents into Bahasa Indonesia to meet the regulatory requirement.
• Ensure accuracy in the description of the device and its risk management to avoid delays in approval.
• Consult with experts (e.g., regulatory consultants) if you’re uncertain about compliance with Indonesian regulations or specific testing requirements.