When applying for Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), the submission of comprehensive technical documentation is crucial. This documentation demonstrates the safety, efficacy, and quality of the medical device. Below are the key requirements for technical documentation:

Technical Documentation Requirements for Class C Medical Device Registration

1. Device Description

• What it should include:
  • Device Name and Model: Clearly state the name and model number of the medical device.
  • Intended Use: Describe the specific medical purpose and indications for use.
  • Technical Specifications: Provide details on design, materials, and operational principles.
  • Diagrams and Images: Include labeled diagrams, photographs, or sketches of the device to aid in understanding.

2. Conformity Assessment Evidence

• What it should include:
  • Documentation proving that the device conforms to relevant international standards (e.g., ISO, IEC).
  • Copies of certifications such as CE marking, FDA approval, or equivalent regulatory approvals from recognized authorities.
  • A Declaration of Conformity stating that the device meets applicable regulatory requirements.

3. Essential Principles of Safety and Performance Checklist

• What it should include:
  • A completed checklist demonstrating compliance with the Essential Principles of Safety and Performance as defined by local regulations.
  • For each principle, provide evidence or references to relevant documents that confirm compliance (e.g., test reports, clinical evaluations).

4. Risk Management Report

• What it should include:
  • A report based on ISO 14971, outlining the risk management process for the device.
  • Identification of potential hazards, risk assessment, risk control measures, and evaluation of the residual risks.
  • Documentation of the ongoing risk management process post-market.

5. Clinical Evidence

• What it should include:
  • Clinical data demonstrating the safety and efficacy of the device, such as clinical trial reports or literature reviews.
  • Summaries of any clinical evaluations conducted, including the methods used, population studied, and results.
  • If applicable, provide information on previous approvals or studies conducted in other jurisdictions.

6. Labeling and Instructions for Use (IFU)

• What it should include:
  • Draft labels for the device, including the product name, manufacturer’s details, and intended use.
  • Comprehensive Instructions for Use (IFU) that provide clear guidelines on the proper use, maintenance, and potential risks associated with the device.
  • Any warnings, contraindications, or important information related to the device’s use.

7. Post-Market Surveillance Plan

• What it should include:
  • A plan detailing the procedures for monitoring the device's performance and safety after it is marketed.
  • Procedures for reporting adverse events and handling product recalls.
  • A description of the methods to collect post-market data, including user feedback and clinical outcomes.

8. Manufacturer’s Information

• What it should include:
  • Information about the manufacturer, including the name, address, and contact details.
  • Certification that the manufacturer’s Quality Management System (QMS) complies with ISO 13485 or equivalent.
  • If applicable, information about the local authorized representative in Hong Kong.

9. Local Authorized Representative (if applicable)

• What it should include:
  • If the manufacturer is not based in Hong Kong, provide the name and contact details of the local authorized representative who will handle regulatory matters on behalf of the manufacturer.

Summary

When preparing technical documentation for Class C medical device registration under MDACS, ensure the following:

• Documentation is comprehensive, accurate, and well-organized.
• All necessary components, including device descriptions, risk management reports, clinical evidence, and labeling, are included.
• Information is aligned with local and international regulatory standards.

By adhering to these technical documentation requirements, applicants can facilitate a smoother registration process for their Class C medical devices in Hong Kong.