The process of registering a Class C medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong involves several key steps. Class C devices are considered medium-high risk, and the registration process ensures that these devices meet the necessary safety and performance requirements before being marketed in Hong Kong.

Here are the detailed steps for registering a Class C medical device:

1. Verify Device Classification

• Ensure that your device is correctly classified as Class C. Class C devices have a medium-high risk to the patient, often used in higher-risk medical procedures or therapies.
• Review the classification guidelines in Guidance Notes GN-01 (available on the MDCO website) to confirm the correct class for your device.

2. Prepare Documentation

You will need to gather and prepare the following documents before submitting your application:

• Application Form (MD-C2): Fill out the form which is available on the MDCO website.
• Device Description: Detailed description of the medical device, including its intended use, design, and materials.
• Conformity Assessment Documents: Provide proof that the device complies with recognized international safety standards, such as CE marking or FDA approval. This may include:
  • Declarations of conformity
  • Certification by a notified body (ISO 13485 or equivalent)
  • Test reports
• Essential Principles Checklist: Show that the device meets the Essential Principles of Safety and Performance. This is required to demonstrate compliance with international standards.
• Risk Management Report: Based on ISO 14971 or equivalent, outlining the risks associated with the device and how those risks are mitigated.
• Clinical Evidence: Clinical trials or evaluations demonstrating the safety and performance of the device in its intended use.
• Post-Market Surveillance Plan: A plan for monitoring the safety and performance of the device after it is marketed.
• Manufacturer’s Information: Including details of the manufacturer and, if applicable, a local authorized representative in Hong Kong.
• Labeling and Instructions for Use: Provide product labels and user manuals that contain all necessary information, such as instructions for safe use and warnings.

3. Submit the Application

• Submit the completed application form and supporting documents to the Medical Device Division of the Department of Health (MDCO).
• Applications can be submitted in either electronic or hard copy format.

4. Pay the Application Fee

• A non-refundable application fee is required when submitting your application. The fee amount varies depending on the class of the device, and you can check the latest fee schedule on the MDCO website.

5. Application Review Process

After submission, the application will go through two review stages:

• Administrative Review: This is to check that the application is complete, with all required documents and information.
• Technical Review: MDCO will assess the safety, quality, and performance of the device based on the submitted data. They will check for compliance with international standards and evaluate the risk management and clinical evidence provided.

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