To apply for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong, you need to submit your application to the Medical Device Control Office (MDCO), which operates under the Department of Health. Here’s how you can apply:

Application Process

1. Online Submission:

   • The MDCO has an online application system that allows you to submit your registration application electronically. This is the preferred method for submitting applications.

2. Postal Submission:

   • Alternatively, you can submit your application by postal mail if you are unable to use the online system. Ensure that all documents are complete and organized.

Where to Apply

• Medical Device Control Office (MDCO)
  • Website: MDCO Official Website
  • Contact Information:
    • Address:

      mathematica复制代码Medical Device Control OfficeDepartment of Health21/F, Wu Chung House213 Queen’s Road East, Wan ChaiHong Kong

    • Phone: +852 2961 8989
    • Email: MDCO Email Contact

Steps to Apply

1. Prepare Documentation: Collect all necessary documents, including the application form, technical documentation, clinical data, labeling, and payment receipt.

2. Submit Application:

   • For online submission, visit the MDCO website and navigate to the online application portal.
   • For postal submission, send your completed application and documents to the address mentioned above.

3. Payment: Ensure that you include the application fee payment as specified by the MDCO.

Additional Resources

• Guidelines: Review the specific guidelines for Class IV IVD devices on the MDCO website to ensure you meet all regulatory requirements before applying.
• FAQs and Support: The MDCO website may have a FAQ section that can help clarify common questions regarding the application process.

By following these steps and submitting your application to the MDCO, you can initiate the MDACS registration process for your Class IV in vitro diagnostic medical device in Hong Kong.