To apply for Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you will need to prepare specific documents and submit them to the Medical Device Division (MDD) of the Department of Health. Here’s a step-by-step guide on the application process and where to submit it.

1. Steps to Apply for Class I IVD Medical Device Registration

Step 1: Confirm Device Classification

• Classification Verification: Make sure that your device qualifies as a Class I IVD under MDACS. Class I IVDs are typically low-risk diagnostic devices with minimal risk to patients and users.

Step 2: Prepare Required Documentation

• Complete the MD-IVD-1 Application Form: This form is specifically for Class I IVD registration and includes fields for device details, manufacturer information, and intended use.
• Technical Documentation: Include a detailed description of the device, labeling, instructions for use, risk analysis, and evidence supporting the device’s safety and performance.
• Declaration of Conformity: A formal statement from the manufacturer confirming that the device complies with applicable standards.
• Quality Management System (QMS) Documentation: Although not mandatory, providing ISO 13485 certification or a description of quality control practices enhances your application.
• Manufacturer Information: Full details of the manufacturer, including the contact information of an authorized representative if the manufacturer is based outside Hong Kong.

Step 3: Submit the Application

• Organize the Documents: Arrange the application form and all supporting documents in the correct order.
• Submit to MDD: Send the application package by mail or deliver it in person to the Medical Device Division (MDD) in Hong Kong.

2. Where to Submit the Application

• Medical Device Division (MDD), Department of Health

  • Address: Room 3101, 31/F, Hopewell Centre, 183 Queen's Road East, Wan Chai, Hong Kong.
  • Phone: (+852) 3107 8484
  • Email: mdd@dh.gov.hk

• Online Resources: The Department of Health’s Medical Device Control Office website provides downloadable forms, guidelines, and updates on the MDACS registration process. Visit their website for the latest application forms and detailed instructions.

Key Considerations

• Application Completeness: Ensure all documentation is complete and consistent with MDACS standards.
• Application Language: Documents must be prepared in English or Chinese.
• Application Fees: While Class I devices generally incur minimal or no fees, confirm the fee structure with the MDD.
• Post-Market Surveillance: After registration, ensure compliance with post-market monitoring requirements, including tracking adverse events and reporting significant changes to the device.

By preparing the required documents carefully and submitting them to the MDD, you can facilitate the registration process for your Class I IVD device under the Hong Kong MDACS.

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