To apply for Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you need to follow specific procedures laid out by the Medical Device Control Office (MDCO), under the Department of Health. Here’s a step-by-step guide:

1. Understand the Classification

• Confirm that your medical device falls under Class C. Class C refers to medium-high risk devices. This classification is based on the intended use and the level of risk associated with the device.

2. Prepare the Required Documentation

The required documents include:

• Application Form (MD-C2 Form): Available from the Department of Health’s website.
• Essential Principles Checklist: Demonstrates that your device meets the safety and performance requirements.
• Conformity Assessment Evidence: Such as certifications, testing reports, or other documentation showing compliance with recognized standards (e.g., CE marking, US FDA approval).
• Device Description: Including design, materials, and specifications.
• Labeling and Instructions for Use: Provide the label and user manual with necessary information.
• Risk Management Report: Details the potential risks associated with the device and their mitigations.
• Clinical Evidence: Proof of clinical trials or evaluations that demonstrate the safety and effectiveness of the device.
• Post-Market Surveillance Plan: How you plan to monitor the device’s performance after it’s on the market.
• Manufacturer's Information: Information about the manufacturer and, if applicable, an authorized local representative.
• Quality Management System Certification: Such as ISO 13485, if available.

3. Submit the Application

Submit the completed application along with the required documents to the Medical Device Division of the Department of Health (MDCO):

• Via email (for electronic submissions) or
• In hard copy format at the MDCO office.

4. Pay the Application Fee

There’s a non-refundable application fee that must be paid at the time of submission. The amount depends on the device class.

5. Review Process

After submission, MDCO will review your application, including:

• Administrative Review: To check the completeness of your application.
• Technical Review: To assess the safety, quality, and effectiveness of the device.

They may ask for additional information or clarifications during this process.

6. Approval and Listing

If your application is approved, your device will be registered and listed in the MDACS Medical Device Register. You will receive a listing certificate and the registration number.

7. Post-Market Obligations

• Ensure compliance with post-market surveillance requirements, including reporting adverse events or updates to the device.
• Renew the registration periodically (usually every 5 years), as required.

Helpful Resources:

• MDACS Guidelines: MDACS Website
• Application Forms and Fees: Available on the Department of Health website.

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