For B-class medical device registration in Indonesia under the Ministry of Health (MOH) and BPOM, specific technical documentation is required to demonstrate the safety, efficacy, and compliance of the device with Indonesian regulatory standards. These documents provide BPOM with the necessary information to assess the device's quality, performance, and risks.

Here’s a list of the key technical document requirements for B-class medical device registration:

1. Device Description and Classification

• Detailed Device Information:
  • Name of the device, model, and type.
  • Intended use and indications (e.g., diagnostic, therapeutic, monitoring).
  • Functionality and operational principles of the device.
  • Classification justification: Explanation and evidence to support the B-class classification based on its risk level (moderate risk devices). This will include references to relevant regulations or standards.

2. Manufacturer Information

• Manufacturing License: A copy of the valid manufacturing license from the regulatory authority in the country where the device is produced, indicating the manufacturing facility complies with relevant regulations and standards.
• Good Manufacturing Practices (GMP) Certificate: Proof that the manufacturing facility adheres to Good Manufacturing Practices (GMP). If the manufacturer is located outside Indonesia, GMP certification must be issued by the appropriate regulatory authority (e.g., FDA, CE, or other recognized bodies).
• ISO 13485 Certification (if applicable): Proof that the manufacturer complies with ISO 13485, which outlines the quality management system requirements for medical devices. This is often required for manufacturers based outside Indonesia.

3. Clinical Data and Performance Evaluation

• Clinical Evaluation: If applicable, you must provide clinical data supporting the safety and efficacy of the device, especially for devices that are used in critical or life-supporting applications.
  • This may include:
    • Clinical trial data (if applicable).
    • Post-market clinical experience or literature reviews (if the device is similar to devices already marketed in other regions).
• Risk Management Report: A report detailing how the device's risks have been assessed and mitigated, typically in accordance with ISO 14971 (Risk management for medical devices).
  • This document should outline:
    • Identified risks associated with the device.
    • The procedures and measures taken to minimize or control these risks.

4. Product Labeling and Instructions for Use

• Labeling: The device's labels must be in Bahasa Indonesia and include:
  • Device name, model, manufacturer’s information, and intended use.
  • Warnings, contraindications, and precautions.
  • Batch number, serial number, and expiry date (if applicable).
  • Storage conditions (e.g., temperature, humidity requirements).
  • Instructions for use (IFU).
• Instructions for Use (IFU):
  • Detailed instructions for safe and effective use of the device.
  • Indications for use, contraindications, warnings, precautions, and maintenance instructions.
  • Translated into Bahasa Indonesia.

5. Testing and Safety Compliance

• Safety and Performance Testing Reports: These include documentation proving that the device complies with relevant safety standards. For example:
  • Electrical safety (for electrical medical devices), which may require compliance with IEC 60601 standards.
  • Biocompatibility testing for devices that come into contact with human tissue, ensuring they are free from harmful effects (e.g., testing in accordance with ISO 10993).
  • Sterility testing (if the device is sterile) to ensure that the device maintains sterility until it is used.
• Environmental Compliance: Proof that the device complies with environmental standards (e.g., RoHS, REACH) if applicable.

6. Free Sale Certificate (FSC)

• Free Sale Certificate: This is a certificate issued by the regulatory authority in the country of origin, confirming that the device is legally sold and available on the market there. It demonstrates that the device is recognized as safe for public use and has been approved for sale in the manufacturer's home market.

7. Certificate of Conformity (if applicable)

• If the device is already registered in other jurisdictions (e.g., CE Mark, FDA approval), a Certificate of Conformity or similar documentation may be required to demonstrate that the device complies with international regulatory standards.

8. Packaging and Transportation Information

• Packaging: Information on the device's packaging, including:
  • Type of packaging materials used (e.g., cardboard, plastic, blister packs).
  • Storage conditions (e.g., temperature and humidity requirements).
  • Shelf life (if applicable).
• Labeling and Barcodes: If the device is sold in packages, labels must include necessary information and compliance symbols.

9. Declaration of Conformity (for European Devices)

• If the device has already been approved or is in compliance with CE marking (in the European Union), you may need to provide a Declaration of Conformity that confirms the device meets all relevant European directives and standards.

10. Additional Documents

• Post-Market Surveillance Plan: Although not always required for B-class devices, BPOM may ask for a post-market surveillance plan, especially if the device is innovative or has a high-risk profile. This outlines the monitoring activities after the device is marketed to ensure its continued safety and performance.