Handling the registration of B-class medical devices under the Medical Device Administrative Control System (MDACS) in Hong Kong requires adherence to specific regulatory requirements. Here’s a comprehensive overview of these requirements:

1. Device Classification

• Correct Classification: Ensure that the device is classified as Class B according to the Medical Device Classification Rules. This involves determining the intended use and associated risks of the device.

2. Documentation Requirements

To register a B-class medical device, the following documentation must be prepared and submitted:

• Application Form:

  • Complete the official MDACS application form for medical device registration.

• Device Description:

  • Provide a clear and detailed description of the device, including its purpose, design, components, and intended user population.

• Evidence of Safety and Performance:

  • Submit clinical data or scientific evidence demonstrating the device's safety and effectiveness. This may include:
    • Clinical trial results.
    • Preclinical studies.
    • Literature reviews.
    • Bench testing data.

• Labeling and Instructions for Use:

  • Include draft labeling that complies with regulatory requirements. This should contain:
    • Product name.
    • Manufacturer details.
    • Instructions for use.
    • Warnings and precautions.
    • Storage and handling instructions.

• Quality Management System (QMS) Documentation:

  • Demonstrate that the manufacturing facility adheres to a quality management system, typically ISO 13485, or an equivalent standard. This includes:
    • Quality manual.
    • Procedures for design control, production, and post-market surveillance.

• Risk Management Report:

  • Provide a risk management report that outlines the identification, evaluation, and mitigation of risks associated with the device, in compliance with ISO 14971 (if applicable).

3. Submission Process

• Online Submission:
  • Applications can be submitted electronically via the MDACS e-portal or through traditional mail. Ensure all documents are complete and formatted according to MDCO specifications.

4. Fees

• Registration Fees:
  • Be prepared to pay any applicable registration fees associated with the application process. The fee schedule can typically be found on the MDCO website.

5. Compliance with Regulatory Standards

• Adherence to Relevant Standards:
  • Ensure that the device complies with relevant safety and performance standards established by the MDCO. This may include standards from the International Organization for Standardization (ISO) or other recognized standards.

6. Post-Market Surveillance Plan

• Ongoing Monitoring:
  • Develop a plan for post-market surveillance to monitor the device's performance and safety once it is on the market. This includes tracking adverse events and implementing corrective actions as necessary.

7. Communication with MDCO

• Inquiries and Clarifications:
  • Maintain open communication with the MDCO. Be prepared to respond to any requests for additional information or clarifications during the review process.

8. Record Keeping

• Documentation Retention:
  • Keep thorough records of all submissions, correspondence, and approvals related to the registration process for compliance and reference purposes.

Summary

Handling B-class medical device registration under MDACS requires careful attention to classification, comprehensive documentation, adherence to regulatory standards, and ongoing compliance. It’s advisable to consult the MDCO website and consider seeking expert guidance to navigate the process effectively.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn