To register and apply for Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you need to submit the application and required documentation to the Medical Device Division (MDD) of the Department of Health in Hong Kong. Here’s how to proceed:

Where to Apply

1. Medical Device Division (MDD), Department of Health, Hong Kong
   • The MDD is responsible for overseeing the MDACS registration process, reviewing applications, and managing the database of registered devices. All application materials for Class I IVD devices should be submitted to the MDD.

How to Submit Your Application

1. Application Form and Supporting Documents

   • Complete the MD-IVD-1 form, specifically for Class I IVD devices, which is available on the Department of Health’s website.
   • Prepare all required supporting documents, including technical files, Declaration of Conformity, and quality management system documentation, as well as any additional materials that demonstrate the device’s safety and performance.

2. Submission Method

   • By Mail or In-Person: Applications can typically be submitted by mailing the completed application form and supporting documents to the Medical Device Division’s office, or by delivering them in person.

   • Contact Information:

     • Address: Medical Device Division, Department of Health, 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: Check the Department of Health’s official website (Medical Device Control Office) for forms, guidelines, and updates regarding submission procedures.

Recommendations

• Authorized Representative (if applicable): For manufacturers based outside Hong Kong, consider appointing a local authorized representative to liaise with the MDD and handle administrative tasks.
• Confirm Submission Requirements: As requirements and processes can be updated, it’s wise to confirm any specific submission instructions directly with the MDD.

By following these steps and submitting the application to the MDD, you’ll initiate the registration process for a Class I IVD device under Hong Kong’s MDACS.

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