The process of registering a Class C medical device under Hong Kong’s Medical Device Administrative Control System (MDACS) is aimed at ensuring that medium-high risk devices meet essential safety and performance standards before being used in healthcare settings. Here’s a breakdown of the process, required documents, and important considerations for successfully completing this registration.

1. Registration Process for Class C Medical Devices under MDACS

Step 1: Determine the Device Classification

• Confirm that the device is correctly classified as Class C. Class C refers to medium-high risk devices (e.g., surgical lasers, long-term implants).
• Classification is based on factors such as intended use, invasiveness, and the duration of contact with the patient.

Step 2: Compile the Required Documents

• You must gather comprehensive documentation to support the safety, effectiveness, and quality of your device. (Details in the next section)

Step 3: Submit the Application

• Submit the application form and the required documents to the Medical Device Control Office (MDCO), either electronically via email or physically by mail or in person.
  • Address for submissions:

    java复制代码Medical Device Control Office (MDCO)Room 3101, 31/F, Hopewell Centre,183 Queen's Road East, Wan Chai, Hong Kong

• Use the MD-C2 Form (Application Form for Class C Medical Devices) for registration.

Step 4: Pay the Application Fee

• Pay the non-refundable application fee (around HKD 5,060 for Class C devices) when submitting the application.
• Follow the payment instructions provided by MDCO (via bank transfer, check, etc.).

Step 5: MDCO Review Process

• Administrative Review: MDCO checks if your application is complete and whether all required documents are submitted.
• Technical Review: The device's safety, quality, and compliance with international standards are evaluated. MDCO may request further information or clarification during this stage.
• Approval: Once all reviews are successfully completed, the device is listed on the MDACS register, and a listing certificate is issued.

Step 6: Post-Market Surveillance

• After approval, you must comply with post-market monitoring requirements, including:
  • Reporting adverse events and incidents.
  • Submitting periodic safety updates.
  • Ensuring that the device continues to meet all safety standards.

2. Required Documents for Class C Medical Device Registration

To register a Class C device, you must provide comprehensive documentation demonstrating the device’s safety, effectiveness, and compliance with international standards. The required documents include:

1. Application Form (MD-C2)

   • Fill out and submit the MD-C2 form, which is specifically for Class C medical devices.

2. Device Description and Technical Information

   • Detailed description of the medical device, including its intended use, technical specifications, design, and materials used.

3. Conformity Assessment Evidence

   • Proof that the device complies with international safety standards (e.g., CE marking, US FDA approval).
   • This can include:
     • Declarations of conformity.
     • Third-party certification (ISO 13485 or equivalent).
     • Testing reports and assessments by a recognized notified body.

4. Essential Principles Checklist

   • A checklist showing that the device complies with the Essential Principles of Safety and Performance of medical devices, covering risk management, design, and manufacturing.

5. Risk Management Report

   • A report based on ISO 14971 or equivalent, detailing risks associated with the device and the mitigation measures taken during design and production.

6. Clinical Evidence

   • Provide clinical data or trial results that demonstrate the safety and efficacy of the device in its intended use.

7. Labeling and Instructions for Use

   • Submit product labels and the Instructions for Use (IFU). Labels should include the following:
     • Product name, intended use, manufacturer information.
     • Warnings, contraindications, and precautions.
     • Instructions for safe use and handling.

8. Post-Market Surveillance Plan

   • A comprehensive plan outlining how you will monitor the device’s performance after it has been placed on the market. This should include procedures for reporting adverse events and recalls.

9. Manufacturer's and Local Representative’s Information

   • Provide details about the manufacturer, including their Quality Management System (QMS) (e.g., ISO 13485 certification).
   • If the manufacturer is based outside Hong Kong, you need to appoint a local authorized representative in Hong Kong, who will handle regulatory and post-market obligations.

10. Declaration of Conformity

• A signed declaration that confirms the device meets all relevant regulatory requirements and conforms to the Essential Principles of Safety and Performance.

3. Important Considerations for Class C Medical Device Registration

a. Device Classification

• Ensure that the device classification is correct. Incorrect classification (e.g., registering a higher-risk device as Class C when it should be Class D) may lead to rejection of the application.

b. Conformity with International Standards

• Your device must conform to international standards (e.g., ISO 13485 for QMS, ISO 14971 for risk management, CE marking, FDA approval). Having this in place reduces delays during the technical review process.

c. Quality Management System (QMS)

• It is critical that the manufacturer operates under a certified QMS (ISO 13485 or equivalent). This demonstrates that the device is consistently designed and manufactured to meet regulatory requirements.

d. Post-Market Obligations

• Be aware that registration is not a one-time process. Post-market surveillance and adverse event reporting are mandatory. You need to have a system in place for monitoring device performance after approval.

e. Renewal of Registration

• Registrations are generally valid for 5 years. Ensure that you apply for renewal before the expiration date to maintain the listing on the MDACS Medical Device Register.

f. Language of Documents

• All documents submitted must be in either English or Chinese. If the original documents are in another language, they must be translated by a certified professional.

Summary of the Process:

1. Classify your device as Class C.
2. Prepare and submit the MD-C2 form along with the required documents.
3. Pay the application fee (around HKD 5,060 for Class C devices).
4. The MDCO reviews the application (administrative and technical reviews).
5. Upon approval, your device is listed in the MDACS Medical Device Register.
6. Post-market monitoring and reporting obligations must be met continuously.

By following these steps and ensuring that you meet all regulatory requirements, you can successfully register your Class C medical device under Hong Kong MDACS.

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