To apply for Class II medical device MDACS registration in Hong Kong, you will need to submit your application to the Medical Device Control Office (MDCO), which operates under the Department of Health (DH) in Hong Kong. The MDCO is responsible for managing the registration of medical devices under the Medical Device Administrative Control System (MDACS).

Where to Apply:

1. Online Submission (If available):

   • You may be able to submit the application for registration of Class II medical devices through the MDACS online platform, which is hosted by the Hong Kong Department of Health.

   • This platform allows you to fill out and submit the registration forms electronically, as well as upload the necessary documents.

   • For more details, visit the MDACS section of the Hong Kong Department of Health website: Department of Health - Medical Device Control Office.

2. Postal Submission:

   • If online submission is not available or you prefer submitting physical copies, you can mail your application and supporting documents to the Medical Device Control Office at the following address:

   Medical Device Control Office (MDCO)
   Department of Health
   21/F, Wu Chung House, 213 Queen's Road East, Wan Chai, Hong Kong
   Tel: +852 3107 2741
   Fax: +852 3107 2697
   Email: mdco@dh.gov.hk (for inquiries)

   • Important: Ensure that all required documents and forms are completed accurately before submission to avoid delays.

3. In-person Submission:

   • In some cases, you may be able to submit your application in person at the MDCO office, though this is generally less common. It's best to contact the MDCO directly to confirm this option and schedule an appointment if needed.

Steps to Apply:

1. Prepare Documents: Collect and prepare all necessary documents, such as the product description, risk management plan, labeling information, compliance certificates, etc.

2. Fill Out Application: Complete the MDACS registration application form.

3. Submit Application: Either submit your application online or mail it to the MDCO office.

4. Follow Up: You can track the progress of your application or provide any additional information if requested by MDCO.

Contact Information for MDCO:

For any questions or assistance with the registration process, you can contact the Medical Device Control Office:

• Phone: +852 3107 2741

• Fax: +852 3107 2697

• Email: mdco@dh.gov.hk

This office is the central point for all medical device registration matters in Hong Kong, and they can assist with any specific queries related to your Class II device registration.

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