Class C Medical Device Registration under Hong Kong MDACS

Class C medical devices are categorized as medium-high risk devices under the Medical Device Administrative Control System (MDACS) in Hong Kong. These devices are subject to more stringent regulatory control compared to lower-class devices, given their potential impact on patient health. Examples of Class C devices include surgical lasers, long-term implantable devices, and infusion pumps.

MDACS is a voluntary registration system managed by the Medical Device Control Office (MDCO), part of the Department of Health in Hong Kong. While voluntary, many hospitals and healthcare providers in Hong Kong may only use devices listed under MDACS, making it an essential process for medical device manufacturers and distributors.

Steps to Apply for Class C Medical Device Registration

Here’s how to apply for registration under MDACS:

1. Verify Device Classification

• First, confirm that your device falls into Class C. This classification is based on intended use, contact duration with the body, and potential risks. The higher the risk, the stricter the requirements.

2. Ensure Compliance with Essential Requirements

• The device must meet the Essential Principles of Safety and Performance of Medical Devices. These are international standards that ensure the safety, quality, and performance of the medical device.
• Gather clinical evidence and documentation to support that the device complies with recognized standards (e.g., CE marking or FDA approval).

3. Prepare Required Documents

You will need to prepare the following:

• Application Form (MD-C2 Form): Fill out the registration form available on the MDCO website.
• Device Description and Technical Information: Provide technical data, specifications, and a description of the device’s functions.
• Labeling and Instructions for Use: Include information on device labels and user manuals that meet regulatory requirements.
• Conformity Assessment Evidence: Submit documentation such as certifications, audit reports, and testing that show the device meets safety standards.
• Risk Management Report: Based on ISO 14971 or equivalent, detailing identified risks and mitigations.
• Post-Market Surveillance Plan: How you plan to monitor the device once it is marketed.
• Manufacturer and Local Distributor Information: Including details about the device’s manufacturer and any local representatives in Hong Kong.
• Quality Management System Certification: ISO 13485 certification or equivalent.

4. Submit the Application

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

• Electronically via email or
• In hard copy format, by submitting it directly to the MDCO office.

5. Pay the Registration Fee

• A non-refundable application fee is required at the time of submission. The exact fee can be found on the MDCO website or the guidance notes attached to the application form.

6. MDCO Review Process

• The MDCO will conduct an administrative review to ensure all documentation is complete and then proceed to a technical review of the device.
• You may be asked to provide additional information or clarification during this phase.
• The review process can take several months, depending on the complexity of the device and the completeness of the submitted documentation.

7. Approval and Listing

• Upon successful review, the medical device will be listed in the MDACS Medical Device Register, and you will receive a certificate of registration with a listing number.
• The listing is valid for a specified period (usually 5 years), after which you need to renew the registration.

8. Post-Market Obligations

• Once your device is listed, you are responsible for post-market monitoring and reporting any adverse events, updates, or safety concerns about the device to the MDCO.

Helpful Resources:

• MDACS Official Website: MDACS
• Application Forms and Guidelines: Available on the MDCO website.