In Hong Kong, the Medical Device Administrative Control System (MDACS) is the framework for the regulation of medical devices, including B-class medical devices, which are considered to pose moderate risks. Here’s a breakdown of the registration process for B-class medical devices under MDACS:

1. Classification of Medical Devices

• Medical devices are classified into four classes (A, B, C, D) based on their risk levels, with B-class devices being moderate-risk devices.

2. Registration Process

• Step 1: Determine the Device Classification
  Confirm that your device falls under Class B by reviewing the Medical Device Classification Rules provided by the Medical Device Control Office (MDCO).

• Step 2: Prepare Documentation
  You will need to prepare several documents, including:

  • Application form for registration.
  • Evidence of safety and performance, such as clinical data or reports.
  • Labeling and instructions for use.
  • Risk management reports and quality management system documentation.

• Step 3: Submit Application
  Submit your application and all necessary documentation to the MDCO. This can typically be done online through the MDACS website or by mailing the documents to the MDCO.

• Step 4: Review Process
  The MDCO will review your application. They may request additional information or clarification. This process may take several weeks.

• Step 5: Approval and Registration
  If your application is approved, you will receive a registration certificate for your medical device. This certificate is required for the legal sale of the device in Hong Kong.

3. Post-Market Surveillance

• After registration, manufacturers are responsible for post-market surveillance of their devices to ensure ongoing safety and efficacy.

4. Further Information and Resources

• For detailed guidelines, you can visit the MDCO website or contact them directly for specific inquiries regarding the registration process.

5. Consultation

• It’s often advisable to consult with regulatory experts or legal advisors who specialize in medical device regulations in Hong Kong to ensure compliance with all requirements.

Summary

To apply for the MDACS registration for B-class medical devices in Hong Kong, determine the classification, prepare and submit the required documentation, and wait for the review and approval from the MDCO. Always refer to official resources for the most current procedures and requirements.